Order No. 1684 by the Ministry of Health of the Russian Federation

GOVERNMENT OF THE RUSSIAN FEDERATION

 

RESOLUTION

 

dated November 30, 2024, No. 1684

 

MOSCOW

 

On Approval of the Rules for State Registration of Medical Devices

 

The Government of the Russian Federation hereby resolves:

1. To approve the attached Rules for the State Registration of Medical Devices.

2. State registration of medical devices, including state registration of medical devices with a low degree of potential risk in their application, for which special conditions of state registration have been established, as well as amendments to the documents contained in the registration dossiers for medical devices, applications for which were submitted to the Federal Service for Surveillance in Healthcare prior to the effective date of this resolution, shall be carried out in accordance with the requirements of the rules for state registration of medical devices that were in force before the effective date of this resolution.

Registration certificates issued for medical devices that have undergone state registration based on an application submitted to the Federal Service for Surveillance in Healthcare prior to the effective date of the Rules approved by this resolution shall remain valid until amendments are made to the information contained in the registry entry of the state register of medical devices and organizations (individual entrepreneurs) engaged in the production and manufacture of medical devices.

3. Medical organizations that meet the requirements for medical organizations conducting clinical trials of medical devices, as approved in the prescribed manner, and that confirm such compliance by March 1, 2025, shall notify the Federal Service for Surveillance in Healthcare by sending a letter to the Service (on paper directly, by registered mail with acknowledgment of receipt, or as an electronic document signed with a qualified electronic signature or a non-qualified electronic signature, the verification key certificate of which is created and used within the infrastructure ensuring information and technological interaction of information systems used for the provision of state and municipal services in electronic form, as established by the Government of the Russian Federation, to the email address of the Federal Service for Surveillance in Healthcare) by September 1, 2025, regarding compliance with the requirements established by subparagraph "f" of paragraph 6 and/or subparagraph "e" of paragraph 7 of the Rules approved by this resolution.

4. To declare void the acts of the Government of the Russian Federation listed in the annex.

5. To approve the attached amendments to the acts of the Government of the Russian Federation.

6. The implementation of the powers provided for in this resolution shall be carried out by the Federal Service for Surveillance in Healthcare within the established limits of the maximum number of its employees determined by the Government of the Russian Federation, as well as the budget allocations provided to the Federal Service for Surveillance in Healthcare for leadership and management in the area of established functions.

7. This resolution shall enter into force on March 1, 2025, except for subparagraph "f" of paragraph 137 of the Rules approved by this resolution, which shall enter into force on September 1, 2025.

Paragraphs 1, 2, and 6 of this resolution and the Rules approved by this resolution shall remain in effect until December 31, 2026, except for paragraphs 63, 87, and 101 of the said Rules, which shall remain in effect until December 31, 2025.

 

 

Chairman of the Government
of the Russian Federation M. Mishustin

 

 

 

 

 

APPROVED

by the Resolution of the Government

of the Russian Federation

dated November 30, 2024, No. 1684

 

RULES
for the State Registration of Medical Devices

 

I. General Provisions

 

1. These Rules establish the procedure for the state registration of medical devices intended for circulation in the territory of the Russian Federation (hereinafter referred to as medical devices).

2. Subject to state registration are any instruments, apparatus, devices, equipment, materials, and other products used for medical purposes, either individually or in combination with one another, as well as with other accessories necessary for their intended use, including specialized software. Such devices are intended by the manufacturer (producer) for the prevention, diagnosis, treatment, and medical rehabilitation of diseases, monitoring the human body's condition, conducting medical research, restoring, replacing, altering anatomical structures or physiological functions of the body, or preventing or interrupting pregnancy, whose functional purpose is not realized through pharmacological, immunological, genetic, or metabolic effects on the human body.

Medical devices specified in Part 5 of Article 38 of the Federal Law "On the Fundamentals of Health Protection of Citizens in the Russian Federation" are not subject to registration in the territory of the Russian Federation.

3. State registration of medical devices is carried out by the Federal Service for Surveillance in Healthcare (hereinafter referred to as the registering authority).

4. The following key terms are used in these Rules:

"safety of medical devices" – the absence of unacceptable risk associated with harm to human life, health, and the environment;

"evidence materials of the manufacturer (producer) of a medical device" – evidence materials (documents) from the manufacturer (producer) of the medical device or another organization containing the results of tests to determine the quality and safety of the medical device, its compliance with the requirements of regulatory documentation, technical and operational documentation of the manufacturer (producer), and/or studies to assess the biological safety of the medical device. These materials also include justifications for selected methods, their validity, and the equipment used for testing;

"applicant" – the manufacturer (producer) of a medical device or an authorized representative of the manufacturer (producer);

"unified personal account of the applicant" – a subsystem of the unified personal account of the applicant in the federal state information system "Unified Portal of State and Municipal Services (Functions)";

"unified personal account of the medical organization" – a subsystem of the unified personal account of the medical organization in the federal state information system "Unified Portal of State and Municipal Services (Functions)";

"quality of medical devices" – the combination of properties and characteristics of a medical device that influence its ability to perform as intended, provided it complies with the requirements of regulatory documentation and the manufacturer’s (producer’s) technical and operational documentation. The intended purpose of a medical device is defined as the decision by the manufacturer (producer) regarding its target use based on its specific properties, ensuring achievement of medical application goals, and reflected in the manufacturer’s (producer’s) technical and operational documentation;

"clinical trials" – a designed and planned systematic study conducted, including the participation of a human as a subject, to evaluate the safety and effectiveness of a medical device;

"model (brand) of a medical device" – a version of a medical device characterized by specific design and technological solutions and specific performance indicators of its intended (functional) purpose;

"regulatory documentation" – a document establishing the requirements for safety, quality, as well as the expected effectiveness of the intended use and the methods for controlling the compliance of the medical device with these requirements. The set of information specified in the regulatory documentation is approved by the registering authority;

"accessory" – a product that is not a medical device, designated by its manufacturer for joint use with one or more medical devices in accordance with their intended purpose;

"manufacturer (producer) of a medical device" – a legal entity or an individual registered as an individual entrepreneur responsible for the development and manufacture of a medical device, making it available for use under their name, regardless of whether the medical device was developed and/or manufactured by this entity or on its behalf by another entity (entities), and bearing responsibility for the safety, quality, and effectiveness of the medical device;

"production site" – a geographically separate facility designed to perform the entire process of manufacturing a medical device or its specific stages. The specific stages of the production process include:

manufacturing the entire medical device or its main components, except for main components that are medical devices registered in accordance with established procedures in the Russian Federation, at geographically separate facilities that are part of the organizational structure of the manufacturer (producer) of the medical device;

manufacturing under contracts with an external manufacturer (contractor) the entire medical device or its main components, except for main components that are medical devices registered in accordance with established procedures in the Russian Federation;

sterilizing the medical device (for medical devices produced in sterile form);

labeling the medical device (when labeling is performed by the manufacturer (producer) of the medical device).

The main components refer to products, excluding spare parts of the medical device, released for circulation under the name of the manufacturer (producer) of the registered medical device, not mechanically connected to other main components of the medical device upon delivery, and ensuring the functioning of the medical device according to its intended purpose.

Buildings, structures, or premises designated as "residential" cannot serve as production sites for medical devices;

"registration dossier" – a set of documents submitted by the applicant for the state registration of a medical device, for making amendments to such documents, for canceling the state registration of a medical device, as well as copies of decisions made by the registering authority and the federal state budgetary institution under its jurisdiction (hereinafter referred to as the expert institution) concerning a specific medical device;

"registration number of a medical device" – a code assigned to a medical device upon its state registration, under which it is entered into the state register of medical devices and organizations (individual entrepreneurs) engaged in the production and manufacture of medical devices (hereinafter referred to as the state register), and which remains unchanged during the circulation of the medical device;

 

"technical documentation of the manufacturer (producer) of a medical device" – a document (or documents) defining the design of the medical device, establishing technical requirements, and containing data for its development, production, application, operation, maintenance, repair, disposal, or destruction;

"technical tests of a medical device" – tests conducted to determine the quality and safety of a medical device, to verify its characteristics (properties) comply with the requirements of regulatory, technical, and operational documentation of the manufacturer (producer), and to make subsequent decisions on the possibility of conducting clinical trials. These tests are performed in a testing laboratory (center) accredited in the national accreditation system, considering its scope of accreditation;

"toxicological studies of a medical device" – studies conducted to assess the biological safety of a medical device and to make subsequent decisions on the possibility of conducting clinical trials. These studies are performed in a testing laboratory (center) accredited in the national accreditation system, considering its scope of accreditation;

"authorized representative of the manufacturer (producer) of a medical device" – a legal entity or an individual registered as an individual entrepreneur, residing in the Russian Federation, authorized by the manufacturer (producer) of a medical device to represent its interests regarding the circulation of the medical device in the Russian Federation, including issues of conformity assessment procedures and state registration;

"operational documentation of the manufacturer (producer) of a medical device" – a document (or documents) intended to familiarize the consumer with the design of the medical device, regulating the conditions and rules of operation (intended use, maintenance, current repair, storage, and transportation). It includes guaranteed values of the main parameters and characteristics (properties) of the medical device, warranty obligations, and information on its disposal or destruction;

"applicant's electronic account " – a service within the automated information system of the registering authority in the information and telecommunication network "Internet" (hereinafter referred to as the Internet), enabling the applicant, after completing identification and authentication procedures, to interact with the registering authority and access information and documents contained in the registration dossier as provided for in these Rules;

"electronic document image" – a document in hard copy converted into electronic form through scanning, preserving its requisites;

"effectiveness of a medical device" – the ability of a medical device to fulfill the intended purpose established by the manufacturer (producer). The effectiveness of a medical device is confirmed through clinical application, including clinical trials.

5. State registration of medical devices, the effectiveness of which requires conducting clinical trials involving human participants and obtaining authorization from the registering authority for conducting clinical trials, shall be carried out in accordance with paragraphs 63–86 of these Rules.

State registration of medical devices, the effectiveness of which does not require conducting clinical trials involving human participants or obtaining authorization from the registering authority for conducting such clinical trials, shall be carried out in accordance with paragraphs 87–100 of these Rules.

Amendments to the documents contained in the registration dossier shall be made in accordance with paragraphs 112–118 of these Rules for amendments that do not require an examination of the quality, effectiveness, and safety of the medical device, and in accordance with paragraphs 120–133 of these Rules for amendments that require an examination of the quality, effectiveness, and safety of the medical device.

Amendments to the documents contained in the registration dossier for software using artificial intelligence technologies classified as a medical device shall be made in accordance with paragraphs 112–118, 120–133, or 135–136 of these Rules.

State registration of medical devices is conducted based on the results of technical tests, toxicological studies, clinical trials (which represent forms of conformity assessment of medical devices considering the classification depending on the potential risk of their use), production inspections, analysis of evidence materials from the manufacturer (producer) of the medical device, quality, effectiveness, and safety examinations of medical devices, as well as tests for the approval of the type of measuring instruments (for medical devices classified as measuring instruments in the field of state regulation of ensuring the uniformity of measurements, the list of which is approved by the Ministry of Health of the Russian Federation).

6. Clinical trials of medical devices (excluding in vitro diagnostic medical devices) are conducted in medical organizations that meet the following requirements:

a) possession of a license for medical activities indicating the list of works (services) constituting medical activities, based on the intended use and application area of the medical devices undergoing testing;

b) inclusion in the charter of the medical organization of the following types of activities:

scientific (research) activities;

conducting clinical trials of medical devices;

c) availability of an intensive care and resuscitation unit (ward) (if clinical trials involve human participants as subjects for devices classified as class 2b and class 3 depending on the potential risk of use);

d) ensuring the protection of confidential information;

e) availability of standard operating procedures regulating the conduct of clinical trials of medical devices, including:

qualification requirements and staff training;

interaction with the ethics committee;

obtaining informed consent;

procedures for conducting clinical trials;

maintenance and record-keeping of clinical trial documentation;

procedures related to the creation and verification of datasets for conducting clinical trials of software using artificial intelligence technologies classified as a medical device (if such trials are conducted);

f) ensuring the entry of data on conducted trials, including the issuance of an evaluation report on the clinical trial results, into the automated information system of the registering authority in accordance with the procedure established by the registering authority;

g) having specialists within the medical organization who directly conduct procedures related to clinical trials or make decisions related to clinical trials, with higher medical education in a specialty corresponding to the area of medical application of the medical device.

7. Medical organizations conducting clinical trials of in vitro diagnostic medical devices must meet the following requirements:

a) a license for medical activities in laboratory diagnostics and clinical laboratory diagnostics;

b) inclusion in the charter of the medical organization of the following types of activities:

scientific (research) activities;

conducting clinical trials of medical devices;

c) ensuring the protection of confidential information;

d) availability of standard operating procedures regulating the conduct of clinical trials of medical devices, including:

qualification requirements and staff training;

procedures for verification and calibration of equipment;

procedures for conducting clinical trials;

maintenance and record-keeping of clinical trial documentation;

e) ensuring the entry of data on conducted clinical trials, including the issuance of an evaluation report on the results of clinical trials of in vitro diagnostic medical devices, into the automated information system of the registering authority in accordance with the procedure established by the registering authority;

f) having specialists within the medical organization who directly conduct procedures related to clinical trials or make decisions related to clinical trials, with higher medical education or secondary professional medical education in a specialty corresponding to the area of medical application of the medical device.

8. Determination of the compliance of a medical organization with the requirements of paragraphs 6 and/or 7 of these Rules is carried out by the registering authority to recognize the competence of the medical organization in conducting clinical trials of medical devices according to the relevant profile of medical care provided by the medical organization.

The registering authority maintains a list of medical organizations conducting clinical trials and publishes it on its official website on the Internet.

9. A medical organization intending to conduct clinical trials of medical devices shall submit to the registering authority, using the federal state information system "Unified Portal of State and Municipal Services (Functions)," an application for conducting clinical trials of medical devices and the documents specified in paragraph 11 of these Rules, in the form of electronic documents or electronic copies of documents signed with a qualified electronic signature or a non-qualified electronic signature, the verification key certificate of which is created and used in the infrastructure ensuring information and technological interaction of information systems used for the provision of state and municipal services in electronic form, as established by the Government of the Russian Federation (hereinafter referred to as the application for conducting clinical trials).

10. The application for conducting clinical trials must include the following information:

a) the full and abbreviated (if available) name, including the trade name, organizational and legal form of the medical organization, address of its location, as well as the telephone numbers and email addresses of the medical organization (if available);

b) details of the license for medical activities;

c) taxpayer identification number;

d) a list of works (services) in accordance with the license for medical activities;

e) information on the presence (or absence) of accreditation in the national accreditation system as a testing laboratory (center) and/or medical laboratory (for medical organizations conducting clinical trials of in vitro diagnostic medical devices);

f) information on the sanitary-epidemiological certificate (indicating the number and date) confirming compliance of the premises necessary for performing works (services) in anesthesiology and resuscitation with sanitary regulations (excluding medical organizations conducting clinical trials of in vitro diagnostic medical devices);

g) information on the sanitary-epidemiological certificate (indicating the number and date) confirming compliance of the premises necessary for performing works (services) in laboratory diagnostics, clinical laboratory diagnostics with sanitary regulations (for medical organizations conducting clinical trials of in vitro diagnostic medical devices);

h) information on the sanitary-epidemiological certificate confirming compliance of the conditions for handling biological substances, biological and microbiological organisms, and their toxins with sanitary regulations (for medical organizations conducting clinical trials of in vitro diagnostic medical devices);

i) details of documents confirming the compliance of specialists in the medical organization directly conducting procedures related to clinical trials or making decisions related to clinical trials with the requirements of subparagraph "g" of paragraph 6 and/or subparagraph "f" of paragraph 7 of these Rules, including the full names of specialists, dates of birth, education level, specialty name, series and number of the education document, its date, and the insurance individual account number.

11. To establish the compliance of medical organizations with the requirements for conducting clinical trials of medical devices, the medical organization must submit the following documents, certified by the medical organization in accordance with the established procedure:

a) copies of documents confirming the availability of an intensive care and resuscitation unit (ward) (in cases of clinical trials involving human participants as subjects for devices classified as class 2b and class 3 depending on the potential risk of use);

b) a copy of a document approved by the head of the medical organization establishing the bed capacity, structure, and staffing schedule of the medical organization;

c) copies of documents confirming the availability of a clinical-diagnostic (diagnostic) laboratory indicating its profile (for medical organizations conducting clinical trials of in vitro diagnostic medical devices);

d) a copy of a document approved by the head of the medical organization establishing the procedure for handling confidential information;

e) copies of standard operating procedures regulating the conduct of clinical trials of medical devices;

f) a copy of a document approved by the head of the medical organization establishing the procedure for transferring information about conducted clinical trials, including details of the issued evaluation report on clinical trial results, into the automated information system of the Federal Service for Surveillance in Healthcare;

g) copies of documents confirming the compliance of specialists in the medical organization directly conducting procedures related to clinical trials or making decisions related to clinical trials with the requirements of subparagraph "g" of paragraph 6 and/or subparagraph "f" of paragraph 7 of these Rules (to be submitted if the documents were obtained by specialists before 1992, issued by educational institutions belonging to the armed forces or military departments of the Russian Federation, or obtained abroad).

12. A medical organization may, at its own discretion, submit documents for which information is specified in the application for conducting clinical trials in accordance with paragraph 10 of these Rules.

The registering authority is not entitled to require the submission of documents and information that are in the possession of bodies providing state services, bodies providing municipal services, other state bodies, local self-government bodies, or organizations subordinate to state or local self-government bodies participating in the provision of state and municipal services.

The registering authority is not entitled to require the medical organization to submit documents not provided for in paragraph 11 of these Rules.

13. The documents specified in paragraph 11 of these Rules must be prepared in multicolor format with a resolution of at least 300 dots per inch in *.pdf format with a text layer allowing for the selection and copying of blocks, as well as for search functionality.

The size of any file containing the documents specified in this paragraph must not exceed 100 MB.

The application for conducting clinical trials and the documents submitted by the medical organization in accordance with paragraph 11 of these Rules are accepted and registered by the registering authority on the day of their receipt.

14. The registering authority shall, within a period not exceeding 20 business days from the date of receipt of the application for conducting clinical trials and the documents submitted by the medical organization in accordance with paragraph 11 of these Rules, review them, verify the completeness and accuracy of the information contained therein, and check the compliance of the medical organization with the requirements for medical organizations conducting clinical trials of medical devices as established by paragraphs 6 and/or 7 of these Rules.

Verification of the founding documents and the presence of a license for medical activities in the medical organization in accordance with the area of medical application of medical devices is carried out by the registering authority using the unified system of interdepartmental electronic interaction and its connected regional systems of interdepartmental electronic interaction or through an interdepartmental request by the registering authority.

15. The registering authority shall, within the period specified in paragraph 14 of these Rules, make a decision on the compliance or non-compliance of the medical organization with the requirements for medical organizations conducting clinical trials of medical devices, as established by paragraphs 6 and/or 7 of these Rules. This decision is formalized in an official resolution.

16. If a decision is made regarding the compliance of the medical organization with the requirements established by paragraphs 6 and/or 7 of these Rules, the registering authority, on the day the decision is made, includes information about the medical organization in the list of medical organizations conducting clinical trials of medical devices and informs the medical organization about its inclusion in the list by posting the corresponding notification in the unified personal account of the medical organization.

17. The list of medical organizations conducting clinical trials of medical devices includes the following information:

a) the date of inclusion in the list of medical organizations conducting clinical trials of medical devices;

b) the full name and organizational-legal form of the medical organization;

c) the address of the medical organization's location;

d) contact phone number and fax (if available);

e) e-mail address (if available);

f) the list of works (services) in accordance with the license for medical activities.

18. If a decision is made that the medical organization does not meet the requirements established by paragraphs 6 and/or 7 of these Rules, the registering authority shall, on the day of the decision, notify the medical organization by posting the corresponding notification with a reasoned explanation of the decision in the unified personal account of the medical organization.

19. Removal from the list of medical organizations conducting clinical trials of medical devices shall be carried out by the registering authority in the following cases:

a) submission of an application for removal from the list of medical organizations conducting clinical trials of medical devices in the form of an electronic document signed with a qualified electronic signature or a non-qualified electronic signature via the unified personal account of the medical organization;

b) identification by the registering authority of violations of mandatory requirements during the clinical trials of medical devices conducted by the medical organization based on the results of state control over the circulation of medical devices;

c) provision of inaccurate information by the medical organization when submitting an application for conducting clinical trials and documents in accordance with paragraph 11 of these Rules, as well as during the preparation of clinical trial reports for medical devices;

d) liquidation of the medical organization or termination of the license for medical activities;

e) failure to submit or untimely submission of the information and documents specified in paragraph 20 of these Rules;

f) failure to notify the registering authority by September 1, 2025, of compliance with the requirements established by subparagraph "f" of paragraph 6 and/or subparagraph "e" of paragraph 7 of these Rules. 

20. If there is a change in the information contained in the list of medical organizations conducting clinical trials of medical devices, the medical organization included in the list must, within 30 calendar days from the date of the change, submit an application to the registering authority using the unified personal account of the medical organization to update the information. The application must be accompanied by documents confirming the changes, in the form of electronic documents or electronic images of documents signed with a qualified electronic signature or a non-qualified electronic signature.

The registering authority, within 20 business days from the date of submission by the medical organization of an application to amend the information contained in the list of medical organizations conducting clinical trials of medical devices:

reviews the submitted application and documents;

notifies the medical organization of the decision in writing by posting it as an electronic document signed with a qualified electronic signature of an authorized official in the unified personal account of the medical organization.

21. If a medical organization is excluded from the list of medical organizations conducting clinical trials of medical devices (except in the case provided for in subparagraph "a" of paragraph 19 of these Rules), the medical organization has the right to reapply to the registering authority for conducting clinical trials after addressing the issues that led to the exclusion, but no earlier than three years from the date of exclusion from the list.

In the event of repeated violations identified by the registering authority during the clinical trials conducted by the medical organization, the organization will be excluded from the list of medical organizations conducting clinical trials of medical devices without the right to reapply for conducting clinical trials.

22. Medical organizations conducting clinical trials of medical devices must enter information about the completed trials into the automated information system of the registering authority within three business days of their completion.

23. The register of issued permits for conducting clinical trials of medical devices is published by the registering authority in the manner established by it on its official website on the Internet.

24. Special conditions for the state registration of domestically manufactured medical devices (medical devices for which the manufacturer (producer) indicated in the registration application (hereinafter referred to as the registration application) is a legal entity or an individual entrepreneur residing in the Russian Federation and having a production site located in the Russian Federation) are provided under the following conditions: technical and toxicological tests of the medical device are conducted, as well as tests for type approval of measuring instruments (for medical devices classified as measuring instruments within the state regulation of ensuring measurement uniformity, the list of which is approved by the Ministry of Health of the Russian Federation) are carried out at the Federal State Budgetary Institution "All-Russian Scientific Research and Testing Institute of Medical Technology" of the Federal Service for Surveillance in Healthcare (hereinafter referred to as the institution), clinical trials are conducted in medical organizations that meet the requirements of paragraphs 6 and 7 of these Rules, are included in the network of national medical research centers approved by the Ministry of Health of the Russian Federation, and for software using artificial intelligence technologies intended for processing medical images obtained from radiological studies, including computed tomography, X-ray imaging, fluorography, and mammography. Clinical trials for such software must be conducted at the State Budgetary Healthcare Institution of the City of Moscow "Scientific and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Healthcare Department" (hereinafter referred to as the clinical center, domestic medical devices), as specified in paragraphs 101–109 of these Rules.

State registration of domestically manufactured medical devices is carried out in accordance with paragraphs 63–86 or 87–100 of these Rules, or in accordance with the special conditions for the state registration of domestically manufactured medical devices established by paragraphs 101–109 of these Rules, at the discretion of the applicant.

25. The fact of state registration of a medical device in accordance with these Rules is confirmed by a registry entry made by the registering authority in the state register (hereinafter referred to as the registry entry).

State registration of a medical device in accordance with these Rules is perpetual.

26. The inclusion of several models (brands) of a medical device in one registry entry, including those belonging to different types of medical devices according to the nomenclature classification of medical devices by type approved by the Ministry of Health of the Russian Federation (hereinafter referred to as the nomenclature classification of medical devices by type), is possible provided that these models (brands) meet all the following criteria:

a) the production of models (brands) of the medical device is carried out by one manufacturer (producer) in accordance with one technical documentation of the manufacturer (producer);

b) the models (brands) of the medical device belong to the same class of potential risk of use;

c) the models (brands) of the medical device have the same functional purpose and principle of operation;

d) the models (brands) of the medical device are intended to determine the presence and/or quantitative content in a biological sample of the same clinically (diagnostically) significant analyte(s) (for in vitro diagnostic medical devices);

e) the models (brands) of the medical device have different configurations that do not affect the principle of operation and functional purpose, allowing for the expansion or specialization of their use for medical purposes (if applicable);

f) the models (brands) of the medical device have different technical parameters that do not affect the principle of operation and functional purpose (if applicable);

g) the models (brands) of the medical device form a size range (model series) or constitute a group of implementations of the medical device. A group of implementations of the medical device refers to products for which a single group drawing of parts and/or one technical documentation of the manufacturer (producer) for the medical device has been developed;

h) the models (brands) of the medical device have the same characteristics regarding:

area of application;

invasiveness;

sterility (including sterilization methods);

frequency of use (single-use, multiple-use by one patient, multiple-use by multiple patients);

operational and design features.

27. The state fee for actions performed by the registering authority in the course of state registration of medical devices is paid in accordance with the legislation of the Russian Federation on taxes and fees.

The registering authority obtains information about the payment of the state fee through access to the State Information System on State and Municipal Payments as provided for by Article 21³ of the Federal Law "On the Organization of the Provision of State and Municipal Services."

28. The registering authority publishes information related to the state registration of a medical device, amendments to the documents contained in the registration dossier, and the cancellation of state registration on its official website on the Internet, in the unified personal account of the applicant, and in the applicant's electronic account.

29. For the purpose of completing the state registration procedure for a medical device, a foreign manufacturer (producer) of the medical device must appoint an authorized representative of the manufacturer (producer) who will act during the circulation of the medical device in the territory of the Russian Federation and ensure that the information about such a representative in the registration dossier is kept up-to-date.

If information about the authorized representative of the manufacturer (producer) is not specified in the documents contained in the registration dossier or is outdated, the foreign manufacturer (producer) must, by September 1, 2025, appoint an authorized representative of the manufacturer (producer) who will act during the circulation of the medical device in the territory of the Russian Federation or update the information about them.

30. Before submitting an application to the registering authority for the registration of a medical device or for making amendments to the documents contained in the registration dossier in accordance with paragraphs 63, 87, 112, 120, and 135 of these Rules or submitting an application to the institution for the examination of the quality, effectiveness, and safety of a domestically manufactured medical device in accordance with paragraph 101 of these Rules, the applicant must collect evidence of the safety and effectiveness of the medical device and prepare the corresponding documents for the registration dossier.

31. For the purpose of preparing the documents contained in the registration dossier for subsequent submission to the registering authority or the institution, the applicant (as applicable, depending on the procedure):

a) ensures the conduct of technical tests and/or includes existing data (evidence materials from the manufacturer (producer) of the medical device) in the document set;

b) ensures the conduct of toxicological studies of the medical device and/or accessories to the medical device that directly or indirectly come into contact with the human body's surface, mucous membranes, or internal environments, where such interaction (contact) is necessary for the performance of their intended functions, and/or includes existing data (evidence materials from the manufacturer (producer) of the medical device) in the document set;

c) ensures the conduct of clinical trials of the medical device (excluding the state registration of medical devices, for which the confirmation of effectiveness requires clinical trials involving human participants and obtaining authorization from the registering authority, carried out in accordance with paragraphs 63–86 of these Rules). 

Clinical trials for the purpose of state registration of a medical device, for which the confirmation of effectiveness requires clinical trials involving human participants (excluding domestically manufactured medical devices, in vitro diagnostic medical devices, medical devices registered in accordance with special conditions established by the Government of the Russian Federation, and software classified as a medical device), are conducted based on a permit for conducting clinical trials issued by the registering authority, as well as an opinion on the ethical justification of conducting clinical trials issued by the Ethics Council in the field of medical device circulation of the Ministry of Health of the Russian Federation (hereinafter referred to as the Ethics Council), in cases established by these Rules.

Clinical trials involving human participants for the purpose of state registration of a domestically manufactured medical device are conducted based on an opinion on the ethical justification of conducting clinical trials issued by the Ethics Council, in cases established by these Rules. A permit for conducting clinical trials involving human participants, issued by the registering authority, is not required for domestically manufactured medical devices, the state registration procedure for which will be carried out in accordance with paragraphs 101–109 of these Rules.

For in vitro diagnostic medical devices, medical devices registered in accordance with the special conditions established by the Government of the Russian Federation, and software classified as a medical device, obtaining a permit from the registering authority for conducting clinical trials, including those involving human participants, is not required;

d) ensures the conduct of tests for type approval of measuring instruments (for medical devices classified as measuring instruments within the state regulation of ensuring the uniformity of measurements, the list of which is approved by the Ministry of Health of the Russian Federation);

e) the conduct of production inspections of medical devices for compliance with the requirements for implementing, maintaining, and evaluating the quality management system of medical devices depending on the potential risk of their use, as approved by the Government of the Russian Federation (hereinafter referred to as the requirements for implementing, maintaining, and evaluating the quality management system of medical devices). Initial production inspections of medical devices for compliance with the requirements for implementing, maintaining, and evaluating the quality management system of medical devices, conducted to present the results to the registering authority or institution as part of the procedures provided for in Sections II–VI of these Rules, must be conducted by the institution or the expert institution.

32. The Ethics Council is a permanent body established by the Ministry of Health of the Russian Federation for the purpose of conducting evaluations of the ethical justification of clinical trials of medical devices involving human participants as subjects (hereinafter referred to as ethical evaluation).

33. The main tasks of the Ethics Council are:

a) conducting ethical evaluations of documents related to the conduct of clinical trials of medical devices;

b) issuing opinions on the ethical justification of the possibility or impossibility of conducting clinical trials of medical devices involving human participants as subjects. 

34. The Ethics Council, in accordance with its assigned tasks, has the right to:

a) receive documents necessary for conducting ethical evaluations;

b) request missing materials necessary for conducting ethical evaluations from the applicant. 

35. The composition of the Ethics Council is approved by the Ministry of Health of the Russian Federation and consists of representatives of medical and scientific organizations, higher education institutions, public organizations, religious organizations, and the media (hereinafter referred to as Council experts).

The number of representatives from medical organizations must not exceed half of the total number of Council experts.

36. The composition of the Ethics Council is revised as necessary, but no more than once a year.

Changes and additions to the composition of the Ethics Council are approved by an order of the Ministry of Health of the Russian Federation.

37. The Ethics Council includes a chairperson, deputies, and members of the Ethics Council.

38. The chairperson of the Ethics Council is appointed by the Minister of Health of the Russian Federation from among Council experts who hold a higher medical education, an academic degree of Candidate of Medical Sciences or Doctor of Medical Sciences, and have experience in conducting clinical trials of medical devices and addressing ethical issues related to clinical trials of medical devices.

39. The chairperson of the Ethics Council provides overall leadership, determines the directions of the Council's work, organizes its activities, assigns responsibilities among Council experts, and oversees the ethical evaluation process.

In the absence of the chairperson, their duties are performed by one of the deputies with a higher medical education.

40. Council experts must not have any dependency on manufacturers (producers) of medical devices or other parties interested in the results of ethical evaluations.

41. The Ethics Council may establish expert groups.

42. The following requirements apply to Council experts:

a) For individuals with higher medical education:

postgraduate and/or additional professional education, a specialist certificate;

experience in conducting clinical trials of medical devices and addressing ethical issues related to clinical trials of medical devices;

b) For other individuals:

higher education;

experience and knowledge in the field of ethical and legal aspects of protecting the rights and freedoms of individuals and citizens.

43. Meetings of the Ethics Council are conducted by the chairperson or, upon their instruction, by a deputy chairperson and are documented in minutes, which are signed by the chairperson or the deputy chairperson of the Ethics Council.

Materials for an upcoming meeting of the Ethics Council are sent to the Council experts by the department of the Ministry of Health of the Russian Federation responsible for the organizational and technical support of the Ethics Council (hereinafter referred to as the department) no later than three business days before the date of the meeting scheduled by the department.

44. A meeting of the Ethics Council is considered valid if at least two-thirds of its members are present.

Council experts participate in the work of the Council personally; delegation of authority is not permitted.

45. Council experts involved in the planned clinical trial of a medical device are not engaged in the ethical evaluation.

46. Decisions of the Ethics Council are made by open voting by a simple majority of the votes of the Council experts present at the meeting.

In the event of a tie, the decision supported by the presiding chairperson of the meeting is considered adopted.

47. Based on the results of the meeting, the Ethics Council issues an opinion on the ethical justification of conducting the clinical trial of a medical device, in the form specified in the annex. The opinion is signed by the chairperson or the deputy chairperson of the Ethics Council. One copy of the opinion is handed to the applicant or sent by registered mail with acknowledgment of receipt, and the second copy is kept by the department.

48. A Council expert who disagrees with the decision has the right to express their dissenting opinion in writing, which is appended to the relevant opinion of the Ethics Council as specified in paragraph 47 of these Rules and becomes an integral part of it.

49. Information about the composition of the Ethics Council and its work plans is published in the relevant section of the Ministry of Health of the Russian Federation's website on the Internet and is kept up to date.

Information on the current activities of the Ethics Council is published in the relevant section of the Ministry of Health of the Russian Federation's website on the Internet within three business days of the Council meeting.

50. At the applicant's request, the expert institution provides consultations prior to the start of the state registration procedure, including on issues related to the state registration of medical devices, such as preliminary analysis and assessment of the registration dossier, in accordance with the procedure established by the registering authority.

Consultation is not mandatory for obtaining the state service for the registration of medical devices.

To adhere to the principles of independence and impartiality during the evaluation of the quality, effectiveness, and safety of medical devices and to avoid potential conflicts of interest, officials of the expert institution who conducted consultations or inspections of medical device production for compliance with the requirements for implementing, maintaining, and assessing the quality management system cannot perform evaluations of the quality, effectiveness, and safety of the medical device for which they provided consultations.

51. Only one of the applications specified in paragraph 63, paragraph 87, subparagraph "a" of paragraph 101, subparagraph "a" of paragraph 112, subparagraph "a" of paragraph 120, or paragraph 135 of these Rules may be submitted by the applicant in relation to a medical device. If a duplicate and/or new application from those mentioned in the first sentence of this paragraph is submitted or sent to the registering authority or institution during the review of the registration dossier under the procedure specified in these Rules (before the final decision provided for by this procedure is made), such an application will not be accepted by the registering authority or institution.

52. The registering authority forms the registration dossier from the following documents (as applicable):

a) the registration application and documents specified in paragraphs 65, 87, or 101 of these Rules; the application for resuming state registration of a medical device and the documents specified in paragraph 80 of these Rules; requests and documents specified in paragraphs 74 or 96 of these Rules; the application for amendments to the documents contained in the registration dossier and the documents specified in paragraphs 112 and/or 120 of these Rules; as well as the application for the cancellation of state registration of a medical device and the documents specified in subparagraph "b" of paragraph 139 of these Rules;

b) a copy of the task order for conducting an evaluation of the quality, effectiveness, and safety of the medical device, issued by the registering authority;

c) opinions issued by the expert institution during the evaluation of the quality, effectiveness, and safety of the medical device;

d) objections from the applicant to the opinion of the expert institution during the evaluation of the quality, effectiveness, and safety of the medical device and decisions of the registering authority following the review of the applicant's objections to the opinion;

e) copies of orders from the registering authority;

f) copies of notifications sent by the registering authority;

g) copies of inspection reports of the medical device production.

53. Documents contained in the registration dossier are submitted to the registering authority using the applicant's unified personal account in the form of electronic documents or electronic images of documents signed with a qualified or non-qualified electronic signature of the applicant.

Documents in hard copy, for which electronic images are submitted by the applicant, must be certified as required.

54. Documents contained in the registration dossier must be prepared in multicolor format with a resolution of at least 300 dots per inch in *.pdf format with a text layer allowing selection, copying, and searching.

The size of any file in the registration dossier must not exceed 100 MB.

Each document in the registration dossier must include its issue date.

55. If the documents contained in the registration dossier are drawn up in a foreign language, they shall be submitted with a duly certified translation into Russian.

56. The manufacturer's (producer's) technical documentation for the medical device, operational documentation for the medical device, including instructions for use or the user manual, may additionally be submitted via the applicant's unified personal account in the form of information signed with a qualified or non-qualified electronic signature of the applicant.

57. The registering authority is responsible for organizing work on the formation and maintenance of the nomenclature classification of medical devices by type.

58. If the type of a medical device changes during the formation and maintenance of the nomenclature classification of medical devices by type, the registering authority notifies the applicant via the electronic account about the planned change in the type specified in the registry entry.

Within 15 business days from the date the notification mentioned in the first paragraph of this point is posted in the applicant's electronic account, the applicant has the right to review it and, if objections exist, submit them to the registering authority via the electronic account. The applicant may submit such objections only once.

If objections from the applicant are not received within the established term, the registering authority proceeds with amending the registry entry.

If objections regarding the change in the type of medical device are received via the applicant's electronic account within a period not exceeding 15 business days, the registering authority reviews them within 30 business days from the date of receipt, including with the involvement of the expert institution.

If a decision is made to recognize the objections as fully or partially justified, no action is taken to amend the registry entry.

If a decision is made to recognize the objections as fully or partially unjustified, the registering authority notifies the applicant of the decision via the applicant's electronic account (with a reasoned explanation of the decision) and proceeds with amending the corresponding registry entry.

59. The terms and sequence of administrative procedures and actions of the registering authority are established by the administrative regulations for the provision of the state service for the state registration of medical devices, developed in accordance with the requirements established by the Government of the Russian Federation.

60. The following are not permitted in the territory of the Russian Federation:

a) registration of different medical devices under the same name;

b) registration as medical devices of products whose names are listed in the State Register of Medicinal Products for Medical Use, the Unified Register of Registered Medicinal Products of the Eurasian Economic Union, or coincide with the name of a biologically active food supplement included in the Unified Register of Certificates of State Registration of Products. If a medicinal product or a biologically active food supplement is a component of a medical device, their names may be used in the name of the medical device;

c) re-registration by the same manufacturer of the same medical device under a different name.

61. For the purpose of undergoing the state registration procedure, the manufacturer (producer) of the medical device must ensure the compliance of the medical device with the following requirements (as applicable):

a) interchangeability of medical devices must not be restricted through the use of special technical or software means or by other methods unless intended to ensure the safety and effectiveness of the medical device;

b) confirmation of the possibility of joint use of the registered medical device with another medical device from a different manufacturer (producer) registered in accordance with the legislation of the Russian Federation on state registration of medical devices is allowed. Such joint use must take into account the features specified in the operational documentation of the manufacturer (producer) for the registered medical device.

62. Decisions and actions (inaction) of the registering authority that result in a violation of the rights of a legal entity or an individual entrepreneur, as well as conclusions of the expert institution based on evaluations conducted in accordance with these Rules, may be appealed by the applicant in accordance with the legislation of the Russian Federation.

 

II. State Registration of Medical Devices Requiring Clinical Trials Involving Human Participants and Authorization from the Registering Authority for Conducting Clinical Trials

 

63. For the state registration of a medical device, where confirmation of effectiveness requires clinical trials involving human participants and authorization from the registering authority for conducting clinical trials, the applicant submits, via the unified personal account, an application for registration along with the documents specified in paragraph 65 of these Rules.

64. The registration application must include the following information:

a) the name of the medical device (indicating the models (brands) of the medical device, their composition, and accessories necessary for the use of the medical device or its models (brands) as intended, if applicable). The applicant must indicate the trademark and other means of individualization of the medical device if these are applied to the medical device packaging;

b) regarding the manufacturer (producer) of the medical device:

for a legal entity - the full and abbreviated (if available) name (with transliteration), organizational and legal form, taxpayer identification number (for manufacturers who are residents of the Russian Federation), address of the registered office, as well as phone number and email address;

for an individual registered as an individual entrepreneur: the last name, first name, and patronymic (if available), details of the identity document, taxpayer identification number (for manufacturers who are residents of the Russian Federation), address of residence, as well as phone number and email address;

c) regarding the authorized representative of the manufacturer (producer):

for a legal entity: the full and abbreviated (if available) name (with transliteration), organizational and legal form, taxpayer identification number, address of the registered office, as well as phone number and email address;

for an individual registered as an individual entrepreneur: last name, first name, and patronymic (if available); details of the identity document; taxpayer identification number; address of residence; as well as phone number and email address;

d) the name(s) (with transliteration) of the production site(s) and the address(es) of their location;

e) the intended purpose of the medical device as established by the manufacturer (producer) in accordance with the technical and operational documentation for the medical device;

f) the type(s) of the medical device in accordance with the nomenclature classification of medical devices by type, in cases provided for by paragraph 26 of these Rules;

g) the class of potential risk of use of the medical device in accordance with the nomenclature classification of medical devices by risk classes depending on the potential risk of their use, as approved by the Ministry of Health of the Russian Federation;

h) the code of the All-Russian Classifier of Products by Types of Economic Activity (hereinafter referred to as the classifier);

i) information on the possibility (or impossibility) of classifying the medical device as:

software that is a medical device;

software using artificial intelligence technologies that is a medical device;

j) information on the presence (or absence) of direct or indirect contact between the medical device and/or its accessories and the surface of the human body, mucous membranes, or internal body environments, where such interaction (contact) is necessary for the performance of their intended function;

k) information on whether the medical device is classified as a measuring instrument in the field of state regulation of ensuring the uniformity of measurements, the list of which is approved by the Ministry of Health of the Russian Federation;

l) the number, date of the protocol of the technical tests of the medical device, the name of the testing laboratory that issued the protocol, and information on its registration number in the register of accredited entities;

m) the number, date of the protocol of toxicological studies of the medical device and/or its accessories that directly or indirectly contact the surface of the human body, mucous membranes, or internal body environments, where such interaction (contact) is necessary for the performance of their intended function, as well as the name of the testing laboratory that issued the protocol and information on its registration number in the register of accredited entities;

n) the number and date of the protocol of tests conducted on the medical device for the purpose of type approval of measuring instruments (for medical devices classified as measuring instruments in the field of state regulation of ensuring the uniformity of measurements, the list of which is approved by the Ministry of Health of the Russian Federation), as well as the name of the testing laboratory that issued the protocol and information on its registration number in the register of accredited entities;

o) the date and number of the inspection report, its validity period, and the name of the organization that conducted the inspection (specified if the inspection was carried out by an inspection organization under the authority of the registering authority);

p) information on the necessity (or lack thereof) of conducting clinical trials involving human participants;

q) information on the presence (or absence) of a medicinal product, pharmaceutical substance, biological material, or other active substance in the composition of the medical device;

r) information on whether the product is released in a sterile (non-sterile) form;

s) details of the document(s) confirming the right of the manufacturer (producer) to use the trademark and other means of individualization of the medical device if applied to the medical device packaging;

t) information on the payment of the state fee (date and number of the payment order(s));

u) information on the registration number and date of the state registration of the medical device (or amendments made to the documents contained in the registration dossier) (as applicable);

v) information on the possibility (or impossibility) of classifying the medical device as in vitro diagnostic medical devices;

w) information on notifications submitted to the registering authority regarding the import of the medical device for the purpose of its state registration;

x) information on the applicant's responsibility for the accuracy and consistency of the information contained in the registration dossier and the registration application.

65. For the state registration of a medical device, where confirmation of effectiveness requires clinical trials involving human participants and authorization from the registering authority for conducting clinical trials, the following documents must be submitted:

a) a copy (copies) of the document(s) confirming the authority of the authorized representative of the manufacturer (producer) to represent the interests of the manufacturer (producer), bear responsibility regarding the circulation of the medical device in the territory of the Russian Federation, including issues related to conformity assessment and state registration procedures for the medical device, as well as to certify documents of the manufacturer (producer). The document(s) must be valid prior to the preparation of the relevant documents. (The document(s) is mandatory for foreign manufacturers (producers); for domestic manufacturers (producers), the document(s) is submitted if there is an authorized representative of the manufacturer (producer));

b) information on the regulatory documentation for the medical device;

c) technical documentation of the manufacturer (producer) for the medical device;

d) operational documentation of the manufacturer (producer) for the medical device, including instructions for use or the user manual of the medical device;

e) color photographic images of the general view of the medical device, models (brands) of the medical device, and accessories necessary for the use of the medical device as intended (size not less than 18 x 24 centimeters), as well as images of labeling and packaging (color layouts of packaging and labels containing the text of the original labeling and additional labeling in Russian applied to medical devices manufactured outside the Russian Federation);

f) a draft description of the type of measuring instrument that is a medical device (for medical devices classified as measuring instruments in the field of state regulation of ensuring the uniformity of measurements, the list of which is approved by the Ministry of Health of the Russian Federation);

g) a calibration method for the type of measuring instrument that is a medical device (for medical devices classified as measuring instruments in the field of state regulation of ensuring the uniformity of measurements, the list of which is approved by the Ministry of Health of the Russian Federation);

h) a draft plan for clinical trials of the medical device involving human participants with supporting materials (if applicable);

i) documents confirming the ability to conduct production at the address(es) specified in the registration application as the production site(s) (as applicable): documents confirming the availability of production conditions; and/or copies of quality management system certificates of compliance with the requirements of the interstate standard GOST ISO 13485-2017 "Medical Devices. Quality Management Systems. Requirements for Regulatory Purposes," approved and implemented as of June 1, 2018 (hereinafter referred to as GOST ISO 13485-2017), or the corresponding international standard ISO 13485:2016 "Medical Devices. Quality Management Systems. Requirements for Regulatory Purposes" (hereinafter referred to as ISO 13485:2016); copies of reports from previously conducted inspections for compliance with these standards (if such certificates of compliance are provided); and/or copies of documents confirming that the quality management system complies with the requirements for implementing, maintaining, and evaluating the quality management system for medical devices (submitted in cases where inspections were conducted by an inspection organization under the authority of a governmental body of a member state of the Eurasian Economic Union authorized to conduct and/or coordinate activities related to the circulation of medical devices in the territory of that state, excluding the Russian Federation);

j) documents confirming the right of the manufacturer (producer) to use the trademark and other means of individualization of the medical device if applied to the medical device packaging (submitted if the information is not included in the relevant registers of the Federal Service for Intellectual Property);

k) copies of documents confirming the quality of the medicinal product, pharmaceutical substance, biological material, and other substances used in the production of the medical device or included in its composition and intended for use only according to the purpose of the medical device as determined by the manufacturer, issued in accordance with the legislation of the country of origin of the medicinal product, pharmaceutical substance, biological material, and other substances;

l) a copy of the document confirming the registration of the manufacturer (producer) as a legal entity or an individual entrepreneur (except for medical devices whose manufacturers are residents of the Russian Federation);

m) a clinical monitoring plan (for medical devices with a class 3 potential risk of use and for medical devices implantable in the human body with a class 2b potential risk of use);

n) evidence materials of the manufacturer (producer) of the medical device (as applicable):

evidence materials of the manufacturer (producer) of the medical device regarding the determination of the quality and safety of the medical device and its compliance with the requirements of regulatory, technical, and operational documentation of the manufacturer (producer);

evidence materials of the manufacturer (producer) of the medical device regarding research for the evaluation of the biological safety of the medical device.

66. The registering authority is not entitled to require the applicant to include in the registration application any information not provided for in paragraph 64 of these Rules or to submit documents not specified in paragraph 65 of these Rules.

The applicant has the right to submit documents, the information on which is included in the registration application in accordance with subparagraphs "l" - "o," "s" and "w" of paragraph 64 of these Rules, at their discretion.

The applicant has the right to submit other necessary documents at their discretion.

67. Within 5 business days from the date of receipt of the registration application and the documents specified in paragraph 65 of these Rules, the registering authority verifies the completeness and accuracy of the information contained therein, including by comparing such information with data provided by government authorities through interdepartmental information interaction via the interdepartmental electronic interaction system.

68. If the registration application is completed in violation of the provisions of paragraph 64 of these Rules, and/or the submitted documents are completed in violation of the provisions of paragraphs 53–55 of these Rules, and/or the registration application and submitted documents contain inaccurate information, or the documents specified in paragraph 65 of these Rules are incomplete, the registering authority notifies the applicant of the need to address the identified violations and/or provide the missing documents within 30 business days from the date such notification is posted as an electronic document signed with the qualified electronic signature of an authorized official in the applicant's unified personal account and electronic account. The applicant addresses the identified violations and/or provides the missing documents via the applicant's unified personal account.

The time from the day the registering authority notifies the applicant to the day a response to the notification or notification of non-submission of a response to the request is received is not included in the calculation of the term for state registration of the medical device.

69. Within 2 business days from the completion of the verification provided for in paragraph 67 of these Rules (if the registration application is properly completed and all documents specified in paragraph 65 of these Rules are submitted in full), as well as in cases where the identified violations are addressed and/or the documents specified in paragraph 65 of these Rules are submitted within a period not exceeding 30 business days, the registering authority makes a decision to commence state registration of the medical device.

70. If the identified violations are not addressed and/or the missing documents are not submitted within a period not exceeding 30 business days, including considering the provisions of paragraph 53 of these Rules, the registering authority makes a decision to cease further consideration of the registration application and the documents specified in paragraph 65 of these Rules and informs the applicant by posting a corresponding notification, signed with the qualified electronic signature of an authorized official, in the applicant's unified personal account and electronic account, with a reasoned explanation of the reasons for the decision.

71. State registration of medical devices, for which confirmation of effectiveness requires clinical trials involving human participants and authorization from the registering authority for conducting such trials, is carried out by the registering authority within a period not exceeding 50 business days from the date of receipt of the registration application and the documents specified in paragraph 65 of these Rules.

The duration of clinical trials of the medical device involving human participants is not included in this 50-day period.

72. Within 2 business days from the decision to commence state registration of the medical device, the registering authority prepares and issues an assignment for conducting an evaluation of the quality, effectiveness, and safety of the medical device to the expert institution (hereinafter referred to as the assignment for evaluation).

73. The evaluation of the quality, effectiveness, and safety of the medical device, for which confirmation of effectiveness requires clinical trials involving human participants and authorization from the registering authority for conducting such trials, is carried out by the expert institution in stages, in accordance with the procedure approved by the Ministry of Health of the Russian Federation:

a) during Stage I, the registration application and the documents specified in paragraph 65 of these Rules are evaluated to determine the feasibility (or infeasibility) of conducting clinical trials of the medical device involving human participants;

b) during Stage II, the completeness and results of conducted technical tests, toxicological studies, clinical trials, tests for type approval of measuring instruments (for medical devices classified as measuring instruments in the field of state regulation of ensuring the uniformity of measurements, the list of which is approved by the Ministry of Health of the Russian Federation), production inspections, as well as the analysis of evidence materials from the manufacturer (producer) of the medical device (hereinafter referred to as the evaluation of completeness and results of tests and studies) are reviewed.

74. During the evaluation of the quality, effectiveness, and safety of the medical device (at any stage), the expert institution is not permitted to request materials necessary for the evaluation directly from the applicant or any other parties.

If the materials and information contained in the registration application and the documents submitted by the applicant, as specified in paragraph 65 of these Rules, are insufficient for the expert of the expert institution (hereinafter referred to as the expert) to render an opinion, the expert submits a request to the head of the expert institution. The head then addresses the registering authority that issued the assignment for evaluation with a corresponding request. The request must include an exhaustive list of all questions, materials, and information needed by the expert to conduct the evaluation.

The registering authority, within 2 business days from the receipt of the request from the head of the expert institution, sends the applicant a request to provide the necessary materials and information, specifying the nature of the comments and the method of their resolution. This request is sent only once at each stage of the evaluation of the quality, effectiveness, and safety of the medical device in the form of an electronic document signed with the qualified electronic signature of an authorized official, via the applicant's electronic account and unified personal account.

The applicant is required to respond to the registering authority's request via the unified personal account within a period not exceeding 50 business days from the date of the request. Within 2 business days from the receipt of the applicant's response to the request, the registering authority forwards the response to the expert institution. If the applicant fails to respond to the request within 50 business days, the registering authority, within 2 business days, sends a notification to the expert institution regarding the lack of response from the applicant to prepare the expert institution's conclusion based on the documents available to it. 

The time from the date of the registering authority's request to the date of receipt of the applicant's response or the notification of non-submission of a response is not included in the calculation of the evaluation period for the quality, effectiveness, and safety of the medical device.

If the registering authority identifies inaccurate and/or insufficient information and/or non-compliance of the submitted documents with the provisions of paragraphs 53–55 of these Rules in the documents submitted by the applicant in response to the request, the registering authority, within 2 business days, sends (in the form of an electronic document signed with the qualified electronic signature of an authorized official, via the applicant's electronic account and unified personal account) a reasoned decision to the applicant regarding the possibility of resubmitting the revised documents within 50 business days from the date of the request. If the applicant fails to provide the requested materials and information within the specified period, the evaluation of the quality, effectiveness, and safety of the medical device continues based on the documents already available to the expert institution and the information contained in the registration dossier.

75. At Stage I of the evaluation of the quality, effectiveness, and safety of the medical device, the expert institution carries out the following actions within a period not exceeding 17 business days from the receipt of the assignment for evaluation:

a) evaluation of the registration application and the documents specified in paragraph 65 of these Rules to determine the feasibility (or infeasibility) of conducting clinical trials of the medical device involving human participants;

b) preparation and submission to the registering authority of a conclusion regarding the feasibility (or infeasibility) of conducting clinical trials of the medical device involving human participants (indicating the reasons and justification for the infeasibility), in the form approved by the Ministry of Health of the Russian Federation (hereinafter referred to as the conclusion on the clinical trials of the medical device).

76. The grounds for the expert institution issuing a conclusion on the clinical trials of the medical device indicating the infeasibility of conducting clinical trials involving human participants are:

a) non-compliance of the medical device with the requirements of regulatory documentation, technical, and/or operational documentation of the manufacturer (producer);

b) lack of evidence of the safety of the medical device;

c) presence of inaccurate information in the documents contained in the registration dossier.

77. The registering authority, within 5 business days from receiving the conclusion on the clinical trials of the medical device from the expert institution, performs the following actions:

a) evaluation of the conclusion on the clinical trials of the medical device to determine its compliance with the assignment for evaluation. If the conclusion on the clinical trials of the medical device is found to be inconsistent with the assignment, it is returned to the expert institution for revision within a period not exceeding 2 business days from the date the expert institution receives the returned conclusion on the clinical trials of the medical device;

b) in the case of receiving a conclusion on the clinical trials of the medical device as provided in paragraph 76 of these Rules, no later than the next business day after evaluating the conclusion on the clinical trials of the medical device to determine its compliance with the assignment for evaluation, the registering authority places an electronic copy of the conclusion on the clinical trials of the medical device, consistent with the assignment for evaluation, in the applicant's electronic account and provides the relevant information in the applicant's unified personal account.

Within 10 business days from the date of placement in the applicant's electronic account of the conclusion on the clinical trials of the medical device as specified in paragraph 76 of these Rules, the applicant has the right to review the conclusion on the clinical trials of the medical device and, if there are objections, submit their objections to the conclusion via the applicant's electronic account.

If objections to the conclusion on the clinical trials of the medical device provided for in paragraph 76 of these Rules are submitted via the applicant's electronic account within a period not exceeding 10 business days, the registering authority, within 30 business days from the receipt of the objections, reviews them with the involvement of the expert institution that issued the corresponding conclusion on the clinical trials of the medical device. If the objections are not submitted within the specified period, the registering authority carries out the actions provided for in subparagraphs "c" and "d" of this paragraph. When reviewing objections, the registering authority, if necessary, involves the applicant to provide explanations.

Based on the results of the review of objections, a decision is made to either fully or partially recognize the objections as justified. This decision is formalized in a letter from the registering authority and sent to the expert institution, along with the conclusion on the clinical trials of the medical device provided for in paragraph 76 of these Rules, for revision within a period not exceeding 5 business days from the date the expert institution receives the returned conclusion on the clinical trials of the medical device. Alternatively, the objections may be deemed fully unjustified.

The time from the date the registering authority places the conclusion on the clinical trials of the medical device specified in paragraph 76 of these Rules in the applicant's electronic account to the date of the decision following the review of objections is not included in the calculation of the period for evaluating the quality, effectiveness, and safety of the medical device;

c) making a decision on granting authorization for conducting clinical trials of the medical device or refusing state registration of the medical device, formalized by an order of the registering authority, and informing the applicant of the decision by placing a corresponding notification in the form of an electronic document, signed with the qualified electronic signature of an authorized official, in the applicant's unified personal account and electronic account;

d) entering a record in the register of issued authorizations for conducting clinical trials of the medical device, the procedure for maintaining which is approved by the registering authority.

78. When a decision is made to grant authorization for conducting clinical trials of the medical device, the registering authority makes a decision to suspend the state registration procedure for the medical device until the date the registering authority decides to resume the state registration of the medical device in accordance with paragraph 81 of these Rules.

79. The applicant, via their unified personal account, notifies the registering authority about the clinical trials of the medical device involving human participants within 5 business days from the start of the trials.

80. Upon the completion of the clinical trials of the medical device involving human participants, the applicant, via their unified personal account, submits to the registering authority an application for resumption of the state registration of the medical device. The application for registration, prepared in accordance with paragraph 64 of these Rules, should include updated information (if necessary) and information about the results of the clinical trials of the medical device involving human participants (for trials completed before September 1, 2025, the information is submitted as documents), as well as the documents specified in subparagraphs "b"–"g" and "m" of paragraph 65 of these Rules, if they were amended based on the results of the clinical trials of the medical device involving human participants, and updated documents specified in subparagraphs "a," "i," and "l" of paragraph 65 of these Rules (if necessary).

The applicant has the right to submit, at their discretion, documents containing information referenced in the application for registration in accordance with subparagraphs "l"–"o," "s," and "w" of paragraph 64 of these Rules (if amended), as well as documents confirming the results of clinical trials completed after September 1, 2025.

81. he registering authority, within 2 business days from the receipt of the documents specified in paragraph 80 of these Rules, makes a decision to resume the state registration of the medical device.

The decision to resume the state registration of the medical device is made by the registering authority based on the results of a verification of the completeness and accuracy of the information contained in the application for resumption of state registration of the medical device and other documents specified in paragraph 80 of these Rules submitted to the registering authority.

If these documents are incomplete, contain inaccurate information, or fail to comply with the formatting provisions of paragraphs 53–55 of these Rules, the registering authority sends (in the form of an electronic document signed with the qualified electronic signature of an authorized official, via the applicant's unified personal account and electronic account) the applicant a decision to terminate further consideration of the application for resumption of state registration of the medical device, along with a reasoned explanation for the decision. Simultaneously, the registering authority informs the applicant about the possibility of resubmitting the application for resumption of state registration of the medical device with revised documents via the unified personal account.

82. At Stage II of the evaluation of the quality, effectiveness, and safety of the medical device, the registering authority, within 2 business days from the decision to resume the state registration of the medical device, forwards the results of the clinical trials of the medical device involving human participants, along with other documents submitted by the applicant in accordance with paragraph 80 of these Rules, to the expert institution based on the assignment for evaluation issued in accordance with paragraph 72 of these Rules.

83. The expert institution, within a period not exceeding 8 business days from the date of receipt of the documents specified in paragraph 80 of these Rules, conducts an evaluation of the completeness and results of the conducted tests and studies and prepares and submits to the registering authority a conclusion based on the evaluation of the quality, effectiveness, and safety of the medical device, in the form approved by the Ministry of Health of the Russian Federation.

84. The grounds for the expert institution issuing a conclusion based on the evaluation of the quality, effectiveness, and safety of the medical device, indicating the impossibility of state registration of the medical device, are as follows:

a) non-compliance of the medical device with the requirements of regulatory documentation, technical, and/or operational documentation of the manufacturer (producer);

b) lack of evidence of the quality, and/or effectiveness, and/or safety of the medical device;

c) determination that the risk of harm to the health of citizens and medical workers from using the medical device outweighs the effectiveness of its use;

d) submission of inaccurate information in the documents contained in the registration dossier.

85. Within a period not exceeding 7 business days from the date of receipt of the conclusion based on the evaluation of the quality, effectiveness, and safety of the medical device, the registering authority carries out the following actions:

a) evaluation of the conclusion based on the results of the evaluation of the quality, effectiveness, and safety of the medical device, as specified in paragraph 83 of these Rules, to determine its compliance with the assignment for evaluation. If the conclusion based on the results of the evaluation of the quality, effectiveness, and safety of the medical device does not comply with the assignment, the conclusion is returned to the expert institution for revision within a period not exceeding 2 business days from the date the expert institution receives the returned conclusion based on the results of the evaluation of the quality, effectiveness, and safety of the medical device;

b) in the case of receiving a conclusion based on the evaluation of the quality, effectiveness, and safety of the medical device, as provided in paragraph 84 of these Rules, no later than the next business day after evaluating such a conclusion to determine its compliance with the assignment for evaluation, the registering authority places an electronic copy of the conclusion based on the evaluation of the quality, effectiveness, and safety of the medical device, consistent with the assignment for evaluation, in the applicant's electronic account and provides the relevant information in the applicant's unified personal account.

Within 10 business days from the placement of the conclusion based on the evaluation of the quality, effectiveness, and safety of the medical device, as specified in paragraph 84 of these Rules, in the applicant's electronic account, the applicant has the right to review the conclusion and, if there are objections, submit them via their electronic account.

If objections to the conclusion specified in paragraph 84 of these Rules are submitted via the applicant's electronic account within a period not exceeding 10 business days, the registering authority reviews them within 30 business days from the date of receipt, involving the expert institution that issued the conclusion. If objections are not submitted within the specified period, the registering authority performs the actions specified in subparagraphs "c" and "d" of this paragraph. When reviewing objections, the registering authority may involve the applicant if explanations are required.

Based on the results of the review, a decision is made either to fully or partially recognize the objections as justified, formalized in a letter from the registering authority, and sent to the expert institution along with the conclusion specified in paragraph 84 of these Rules, which requires revision within a period not exceeding 5 business days from the date the expert institution receives the returned conclusion, or to recognize the objections as fully unjustified.

The time from the date the registering authority places the conclusion based on the evaluation of the quality, effectiveness, and safety of the medical device, as specified in paragraph 84 of these Rules, in the applicant's electronic account, until the decision on the objections is made, is not included in the calculation of the period for evaluating the quality, effectiveness, and safety of the medical device;

c) making a decision on the state registration of the medical device or on the refusal of state registration, formalized by an order of the registering authority, and informing the applicant of the decision by placing a corresponding notification in the form of an electronic document, signed with the qualified electronic signature of an authorized official, in the applicant's unified personal account and electronic account;

d) making an entry in the state register of registration record.

86. The grounds for the registering authority to refuse state registration of a medical device are:

a) receiving from the expert institution a conclusion on the clinical trials of the medical device indicating the impossibility of conducting clinical trials involving human participants;

b) receiving from the expert institution a conclusion based on the evaluation of the quality, effectiveness, and safety of the medical device, indicating the impossibility of state registration of the medical device, and/or the registering authority's decision to recognize the applicant's objections as fully or partially unjustified;

c) identifying, during federal state control (supervision) over the circulation of medical devices, inconsistencies between the data on the effectiveness and safety of the medical device and the information contained in the application for registration and the documents specified in paragraphs 65 and 80 of these Rules.

 

III. State registration of medical devices, the confirmation of the effectiveness of which does not require clinical trials involving human participants or obtaining authorization from the registering authority to conduct such clinical trials

 

87. For the state registration of a medical device, the confirmation of the effectiveness of which does not require clinical trials involving human participants or obtaining authorization from the registering authority to conduct such clinical trials, the applicant, via their unified personal account, submits to the registering authority a registration application prepared in accordance with paragraph 64 of these Rules and additionally containing information on the presence (or absence) of an embedded function in software utilizing artificial intelligence technologies, which is a medical device, for the automatic transfer, in the manner approved by the registering authority, of information on processed data, the results of the software's actions, and the data specified by the procedure for reporting by entities engaged in the circulation of medical devices regarding all cases of adverse effects not indicated in the instructions for use or the operating manual, undesirable reactions during use, specific features of interactions between medical devices, and facts or circumstances that pose a threat to the life and health of citizens and medical workers during the use and operation of medical devices, as approved by the Ministry of Health of the Russian Federation (hereinafter referred to as the procedure for reporting by entities engaged in the circulation of medical devices regarding all cases of adverse effects); as well as information on the results of clinical trials of the medical device (without human participation), including the number and date of the report on the evaluation of the clinical trial results and the name of the medical organization; and the following documents:

a) a copy (copies) of the document(s) confirming the authority of the authorized representative of the manufacturer (producer) to represent the manufacturer's (producer's) interests, assume responsibility for the circulation of the medical device in the Russian Federation, including issues related to conformity assessment and state registration procedures for the medical device, as well as to certify the manufacturer’s (producer’s) document(s) issued before the corresponding documents were prepared (the document(s) is (are) mandatory for foreign manufacturers (producers) and is (are) submitted by domestic manufacturers (producers) if an authorized representative of the manufacturer (producer) is available);

b) information on regulatory documentation for the medical device;

c) technical documentation of the manufacturer (producer) for the medical device;

d) operational documentation of the manufacturer (producer) for the medical device, including instructions for use or the user manual for the medical device;

e) color photographic images of the general view of the medical device, its models (brands), and accessories necessary for the intended use of the medical device (size no less than 18 x 24 centimeters), as well as images of labeling and packaging (color mockups of packaging and labels containing the text of the original labeling and additional labeling in Russian, applied to medical devices manufactured outside the Russian Federation) (except for software that is a medical device);

f) color photographic images of the electronic medium and software interface (size no less than 18 x 24 centimeters) (for software that is a medical device), as well as images of labeling and packaging (if available);

g) draft description of the type of measuring instrument that is a medical device (for medical devices classified as measuring instruments within the scope of state regulation ensuring measurement uniformity, the list of which is approved by the Ministry of Health of the Russian Federation);

h) verification methodology for the type of measuring instrument that is a medical device (for medical devices classified as measuring instruments within the scope of state regulation ensuring measurement uniformity, the list of which is approved by the Ministry of Health of the Russian Federation);

i) documents confirming the results of clinical trials of medical devices (as applicable, depending on the date):

documents confirming the results of clinical trials (for clinical trials completed before September 1, 2025);

documents confirming the results of clinical trials (for clinical trials completed after September 1, 2025) (at the applicant's discretion).

j) documents confirming the capability to carry out production at the address(es) specified in the registration application as the production site(s) (if applicable): documents confirming the availability of production conditions, and/or copies of certificates of compliance with the quality management system requirements of GOST ISO 13485-2017 or ISO 13485:2016, as well as copies of reports on previous inspections for compliance with these standards (if such certificates of compliance are provided), and/or copies of documents confirming the quality management system's compliance with the requirements for the implementation, maintenance, and evaluation of the quality management system of medical devices (submitted if the inspection is conducted by an inspecting organization subordinate to the government authority of a Eurasian Economic Union member state responsible for or coordinating activities related to the circulation of medical devices within that state, excluding the Russian Federation);

k) documents confirming the manufacturer's (producer's) right to use trademarks and other means of individualization of the medical device if applied to the packaging of the medical device (submitted if the information is not included in the relevant registers of the Federal Service for Intellectual Property);

l) copies of documents confirming the quality of pharmaceutical drugs, pharmaceutical substances, biological materials, and other substances used in the manufacturing of the medical device or included in its composition, which are intended for use only as specified by the medical device’s designated purpose, as determined by the manufacturer, and issued in accordance with the legislation of the country of origin of the pharmaceutical drug, pharmaceutical substance, biological material, and other substances (excluding medical devices for in vitro diagnostics);

m) a copy of the document confirming the manufacturer’s (producer's) registration as a legal entity or individual entrepreneur (except for medical devices manufactured by residents of the Russian Federation);

n) a clinical monitoring plan (for medical devices classified under risk class 3, as well as for implantable medical devices classified under risk class 2b);

o) substantiating materials from the manufacturer (producer) of the medical device (if applicable):

substantiating materials from the manufacturer (producer) regarding the determination of the medical device's quality and safety, and its compliance with the requirements of regulatory, technical, and operational documentation of the manufacturer (producer);

substantiating materials from the manufacturer (producer) regarding studies conducted to assess the biological safety of the medical device.

88. The registering authority shall not require the applicant to specify information in the application for registration that is not provided for in paragraph 64 of these Rules or to submit documents that are not stipulated in paragraph 87 of these Rules.

The applicant has the right to submit, at their discretion, documents containing information referenced in the application for registration in accordance with subparagraphs "l"–"o", "s" and "w" of paragraph 64 of these Rules.

The applicant also has the right to submit any other necessary documents at their discretion.

89. Within 5 business days from the date of receipt of the application for registration and the documents specified in paragraph 87 of these Rules, the registering authority shall verify the completeness and accuracy of the information contained therein, including by comparing such information with data provided by government authorities through interagency information interaction via the interagency electronic interaction system.

90. If the application for registration is submitted in violation of the provisions of paragraph 64 of these Rules and/or the submitted documents are prepared in violation of the provisions of paragraphs 53–55 of these Rules, and/or the application for registration and the submitted documents contain inaccurate information, or the documents specified in paragraph 87 of these Rules are incomplete, the registering authority shall notify the applicant of the need to address the identified violations and/or submit missing documents within 30 business days from the date of such notification. The notification shall be provided in the form of an electronic document, signed with an enhanced qualified electronic signature of an authorized official, and placed in the applicant's unified personal account and electronic account. The applicant shall address the identified violations and/or submit the missing documents through the unified personal account.

The time between the notification by the registering authority and the receipt of the applicant's response to the notification or a notice of non-submission of the response shall not be counted when calculating the term for the state registration of the medical device.

91. Within 3 business days from the completion of the verification specified in paragraph 89 of these Rules (in the case of a properly prepared application for registration and complete documents as specified in paragraph 87 of these Rules), as well as in the case of addressing the identified violations and/or submitting the documents specified in paragraph 87 of these Rules within 30 business days, the registering authority shall decide to initiate the state registration of the medical device.

92. If the identified violations are not addressed and/or the missing documents are not submitted within 30 business days, including taking into account the provisions of paragraph 53 of these Rules, the registering authority shall decide to terminate further consideration of the application for registration and the documents specified in paragraph 87 of these Rules. The applicant shall be informed of this decision by placing the corresponding notification with a reasoned justification in the form of an electronic document, signed with an enhanced qualified electronic signature of an authorized official, in the applicant's unified personal account and electronic account.

93. State registration of medical devices, for which confirmation of effectiveness does not require clinical trials involving humans or obtaining permission from the registering authority to conduct such clinical trials, shall be carried out by the registering authority within a period not exceeding 31 business days from the date of receipt of the application for registration and the documents specified in paragraph 87 of these Rules.

94. Within 3 business days from the decision to initiate the state registration of a medical device, the registering authority shall prepare and issue an assignment for examination to the expert institution.

95. For medical devices for which confirmation of effectiveness does not require clinical trials involving humans or obtaining permission from the registering authority to conduct such clinical trials, the examination of the application for registration and the documents specified in paragraph 87 of these Rules shall be conducted simultaneously with the examination of the completeness and results of tests and studies within a period not exceeding 10 business days from the date the expert institution receives the corresponding assignment from the registering authority.

96. During the examination of the quality, effectiveness, and safety of the medical device, the expert institution shall not request materials necessary for the examination from the applicant or other persons.

If the materials and information provided by the applicant in the application for registration and the documents specified in paragraph 87 of these Rules are insufficient for the expert to reach a conclusion, the expert shall raise the issue of obtaining the necessary materials and information with the head of the expert institution, who shall submit an appropriate request to the registering authority that issued the assignment for the examination. This request shall include a comprehensive list of all questions, materials, and information required by the expert to conduct the examination.

The registering authority, within 2 business days from the receipt of the request from the head of the expert institution, shall send the applicant a request for the provision of the necessary information, specifying the nature of the remarks and the method for their resolution. This request shall be sent only once and provided to the applicant in the form of an electronic document signed with the enhanced qualified electronic signature of an authorized official, by placing it in the applicant's electronic account and unified personal account.

The applicant is required to provide a response to the registering authority's request via the applicant's unified personal account within 50 business days from the date the request was sent. Within 2 business days from the receipt of the applicant's response to the request, the registering authority forwards this response to the expert institution. In the event that the applicant fails to provide a response within 50 business days, the registering authority, within 2 business days, sends a notification to the expert institution regarding the applicant's failure to respond to the registering authority's request. This notification enables the expert institution to prepare a conclusion based on the available documents regarding the quality, effectiveness, and safety of the medical device.

The time from the date the registering authority sends the request to the date the response or notification of failure to respond is received is not included in the calculation of the term for the examination of the quality, effectiveness, and safety of the medical device.

If the registering authority detects inaccurate and/or insufficient information or documents, or inconsistencies in the formatting of the documents provided by the applicant in response to the request as outlined in paragraphs 53–55 of these Rules, the registering authority, within 2 business days, sends (in the form of an electronic document signed with the enhanced qualified electronic signature of an authorized official via the applicant's unified personal account and electronic account) the applicant a reasoned decision allowing for the re-submission of revised documents within 50 business days from the date the request was sent. If the applicant fails to provide the requested materials and information within this timeframe, the examination of the quality, effectiveness, and safety of the medical device continues based on the documents and information previously submitted by the applicant and available in the registration dossier.

97. The expert institution conducts an examination of the quality, effectiveness, and safety of the medical device within a period not exceeding 10 business days from the receipt of the documents specified in paragraph 87 of these Rules and submits the conclusion of the examination to the registering authority.

98. The grounds for the expert institution to issue a conclusion based on the results of the examination of the quality, effectiveness, and safety of the medical device, indicating the impossibility of state registration of the medical device, include:

a) non-compliance of the medical device with the requirements of regulatory documentation, technical and/or operational documentation of the manufacturer;

b) lack of evidence of the quality, and/or effectiveness, and/or safety of the medical device;

c) determination that the risk of harm to the health of citizens and healthcare workers due to the use of the medical device outweighs its effectiveness;

d) presence of inaccurate information in the documents contained in the registration dossier.

99. Within a period not exceeding 10 business days from the receipt of the conclusion on the results of the examination of the quality, effectiveness, and safety of the medical device, the registering authority carries out the following activities:

a) evaluation of the conclusion on the results of the examination of the quality, effectiveness, and safety of the medical device, specified in paragraph 97 of these Rules, to determine compliance with the assignment for the examination. If it is determined that the conclusion on the results of the examination of the quality, effectiveness, and safety of the medical device does not comply with the assignment, such a conclusion is returned to the expert institution for revision, which must be completed within 2 business days from the date the expert institution receives the returned conclusion;

b) if the conclusion on the results of the examination of the quality, effectiveness, and safety of the medical device, specified in paragraph 98 of these Rules, is received, no later than the next business day after conducting the evaluation of such a conclusion for compliance with the assignment, the registering authority places an electronic copy of the conclusion, which complies with the assignment, in the applicant's electronic account and sends the relevant information to the applicant's unified personal account.

Within 10 business days from the date the conclusion on the results of the examination of the quality, effectiveness, and safety of the medical device, specified in paragraph 98 of these Rules, is placed in the applicant's electronic account, the applicant has the right to review the conclusion and, if there are objections, submit their objections via the applicant's electronic account.

If the applicant submits objections to the conclusion on the results of the examination of the quality, effectiveness, and safety of the medical device, specified in paragraph 98 of these Rules, via the electronic account within a period not exceeding 10 business days, the registering authority considers these objections within 30 business days from the date of receipt, involving the expert institution that issued the conclusion. If objections are not received within the specified period, the registering authority undertakes the activities specified in subparagraphs "c" and "d" of this paragraph. If necessary, the registering authority involves the applicant to provide explanations during the consideration of objections.

Based on the results of the consideration of objections, the registering authority makes a decision to recognize the objections as fully or partially justified, which is formalized by a letter from the registering authority and sent to the expert institution along with the conclusion on the results of the examination of the quality, effectiveness, and safety of the medical device, specified in paragraph 98 of these Rules, for revision. The revision period shall not exceed 5 business days from the date the expert institution receives the returned conclusion on the results of the examination of the quality, effectiveness, and safety of the medical device. Alternatively, the registering authority may make a decision to recognize the objections as fully unjustified.

The time from the placement of the conclusion on the results of the examination of the quality, effectiveness, and safety of the medical device by the registering authority in the applicant’s electronic account, as specified in paragraph 98 of these Rules, to the adoption of a decision on the results of the consideration of objections is not included in the calculation of the duration of the examination of the quality, effectiveness, and safety of the medical device;

c) adoption of a decision on state registration of the medical device or refusal of state registration, which is formalized by an order of the registering authority, and informing the applicant about the decision by placing the corresponding notification in the form of an electronic document signed by the qualified electronic signature of an authorized official in the applicant’s unified personal account and electronic account;

d) entry of the registry record into the state register.

100. The grounds for the registering authority's decision to refuse state registration of a medical device are:

a) receiving from the expert institution a conclusion on the results of the examination of the quality, effectiveness, and safety of the medical device, indicating the impossibility of state registration of the medical device and/or the adoption by the registering authority of a decision recognizing the applicant’s objections as partially or completely unfounded;

b) detection by the registering authority, based on the results of federal state control (supervision) over the circulation of medical devices, of discrepancies between the data on the effectiveness and safety of the medical device and the data contained in the registration application and the documents specified in paragraph 87 of these Rules.

 

IV. Features of the State Registration of Domestic Medical Devices

 

101. For the state registration of domestic medical devices, the applicant submits or sends to the institution, in hard copy, the following documents and information:

a) an application for the examination of the quality, effectiveness, and safety of the medical device containing information in accordance with paragraph 64 of these Rules (excluding subparagraphs "l"–"o," "s" and "w") and information about the presence of a built-in function in software utilizing artificial intelligence technologies, which constitutes a medical device, for automatic transmission, as established by the registering authority, to the automated information system of the registering authority. This includes data on the processed information, the results of the software operation utilizing artificial intelligence technologies as a medical device, as well as information provided under the procedure for reporting by entities involved in the circulation of medical devices on all cases of adverse effects;

b) a copy (copies) of the document(s) confirming the authority of the authorized representative of the manufacturer (producer) to represent the interests of the manufacturer (producer), to bear responsibility for the circulation of the medical device within the territory of the Russian Federation, including issues related to conformity assessment procedures and state registration of the medical device;

c) information on the regulatory documentation for the medical device;

d) technical documentation of the manufacturer (producer) for the medical device;

e) operational documentation of the manufacturer (producer) for the medical device, including instructions for use or an operation manual for the medical device;

f) color photographic images of the general view of the medical device, models (brands) of the medical device, and accessories required for using the medical device as intended (size not less than 18 x 24 centimeters), as well as images of labeling and packaging (color layouts of packages and labels containing the text of the original labeling and additional labeling in Russian applied to medical devices manufactured outside the Russian Federation) (excluding software that is a medical device);

g) color photographic images of the electronic carrier and interface of the software (size not less than 18 x 24 centimeters) (for software that is a medical device), as well as images of labeling and packaging (if available);

h) information on documents confirming the results of technical tests of the medical device issued by the institution, and supporting materials of the manufacturer (producer) of the medical device (if available);

i) information on documents confirming the results of toxicological studies of the medical device and (or) accessories to the medical device that directly or indirectly contact the surface of the human body, its mucous membranes, or internal body environments, for which such interaction (contact) is necessary to perform their intended functions, issued by the institution, and supporting materials of the manufacturer (producer) of the medical device (if available);

j) information on documents confirming the results of tests of the medical device to approve the type of measuring instruments (for medical devices classified as measuring instruments within the scope of state regulation to ensure the uniformity of measurements, the list of which is approved by the Ministry of Health of the Russian Federation), issued by the institution;

k) documents confirming the results of clinical trials of medical devices issued by medical organizations that meet the requirements approved by the Ministry of Health of the Russian Federation and are included in the network of national medical research centers, the composition of which is approved by the Ministry of Health of the Russian Federation, and software using artificial intelligence technologies designed to process medical images obtained during radiological examinations, including computed tomography, radiography, fluorography, and mammography, provided that clinical trials were conducted at the clinical center (for clinical trials completed before September 1, 2025), or information on the results of clinical trials of the medical device indicating the number and date of the act of clinical trials of the medical device, as well as the name of the medical organization (for clinical trials completed after September 1, 2025).

l) documents confirming the possibility of carrying out production at the address(es) specified in the registration application as the production site(s) (if applicable): documents confirming the availability of production conditions, and (or) copies of certificates of compliance of the quality management system with the requirements of GOST ISO 13485-2017 or ISO 13485:2016, as well as copies of reports of previously conducted inspections for compliance with these standards (if the specified certificates of compliance are provided), and (or) copies of documents confirming compliance of the quality management system with the requirements for implementing, maintaining, and evaluating the quality management system of medical devices;

m) documents confirming the manufacturer's (producer's) right to use the trademark and other means of individualization of the medical device if applied to the packaging of the medical device;

n) copies of documents confirming the quality of the medicinal product, pharmaceutical substance, biological material, or other substances used to manufacture the medical device or included in its composition, intended only for the purposes defined by the manufacturer, issued in accordance with the legislation of the country of origin of the medicinal product, pharmaceutical substance, biological material, or other substances (excluding medical devices for in vitro diagnostics);

o) an inventory of documents required to be submitted under this paragraph, indicating the section IV of these Rules under which the procedure for state registration of the domestic medical device is planned;

p) a clinical monitoring plan (for medical devices of class 3 potential risk and medical devices implanted into the human body of class 2b potential risk);

102. The requirements specified in paragraphs 53, 54, and 56 of these Rules regarding the documents to be submitted under paragraph 101 of these Rules do not apply.

103. The institution, within 25 business days from the date of receipt of the documents specified in paragraph 101 of these Rules:

a) conducts an examination of the application for an assessment of the quality, effectiveness, and safety of the medical device and the documents specified in paragraph 101 of these Rules, including an assessment of the completeness of the documents and the reliability of the information contained therein, concurrently conducting an evaluation of the completeness and results of tests and studies;

b) prepares a conclusion on the results of the assessment of the quality, effectiveness, and safety of the medical device;

c) if the conclusion on the results of the assessment of the quality, effectiveness, and safety of the medical device, specified in subparagraph "b" of this paragraph, is positive, the institution submits this conclusion to the registering authority.

Documents submitted by the applicant under paragraphs 101 and 104 of these Rules are attached to the conclusion on the results of the assessment of the quality, effectiveness, and safety of the medical device, indicating the possibility of state registration of the domestic medical device;

d) if the conclusion on the results of the assessment of the quality, effectiveness, and safety of the medical device is negative, the institution notifies the applicant of the results of the conducted assessment of the quality, effectiveness, and safety of the medical device (by registered mail with acknowledgment of receipt or in the form of an electronic document signed with an enhanced qualified electronic signature of an authorized official, sent to the applicant's email address specified in the application for the assessment of the quality, effectiveness, and safety of the medical device), attaching the conclusion on the results of the assessment of the quality, effectiveness, and safety of the medical device, indicating the impossibility of state registration of the domestic medical device.

104. If the materials and information contained in the documents submitted by the applicant as stipulated in paragraph 101 of these Rules are insufficient for the institution to issue a conclusion on the results of the examination of the quality, efficacy, and safety of the medical device as specified in subparagraph "b" of paragraph 103 of these Rules, the institution shall, within 15 business days from the date of receipt of the documents, send the applicant a request for the provision of the necessary information. This request is sent by registered mail with acknowledgment of receipt or as an electronic document signed with a qualified electronic signature of an authorized official to the applicant's email address specified in the application for the examination of the quality, efficacy, and safety of the medical device. The request must specify the nature of the remarks and how to address them.

This request is sent only once and must contain a comprehensive list of all questions and materials required for the expert to conduct the examination.

The applicant is required to respond to the institution's request within 35 business days from the date the request is sent. The institution shall prepare a conclusion on the results of the examination of the quality, efficacy, and safety of the medical device within 10 business days from the date of receipt of the applicant's response to the request.

If the applicant fails to provide a response to the request within 35 business days, the institution shall prepare a conclusion on the results of the examination of the quality, efficacy, and safety of the medical device based on the documents available to it.

The period from the date the institution sends the request to the date the response to the request is received shall not be included in the calculation of the time required for the examination of the quality, efficacy, and safety of the medical device.

105. A conclusion on the results of the examination of the quality, efficacy, and safety of the medical device, indicating the impossibility of state registration of the domestic medical device, shall be prepared by the institution if the following grounds exist:

a) non-compliance of the medical device with the requirements of regulatory documentation, technical documentation, and/or operational documentation of the manufacturer (producer);

b) lack of evidence of the quality, and/or efficacy, and/or safety of the medical device;

c) determination that the risk of harm to the health of citizens and healthcare workers as a result of the use of the medical device exceeds its effectiveness;

d) the documents specified in paragraph 101 of these Rules are not submitted in full, including under paragraph 104 of these Rules, and/or contain inaccurate information, and/or do not comply with the requirements of paragraph 55 of these Rules.

106. Within 5 business days from the date of receipt of the conclusion on the results of the examination of the quality, efficacy, and safety of the medical device as specified in subparagraph "c" of paragraph 103 of these Rules, the registering authority shall evaluate the conclusion and decide either to return the conclusion to the institution for revision, which shall be completed within 2 business days from the date the institution receives the returned conclusion, or to accept the conclusion on the results of the examination of the quality, efficacy, and safety of the medical device.

107. The institution, within 2 business days from the date of receiving the notification of acceptance of the conclusion on the results of the examination of the quality, efficacy, and safety of the medical device, shall notify the applicant (by registered mail with acknowledgment of receipt or as an electronic document signed with a qualified electronic signature of an authorized official, sent to the applicant's email address specified in the application provided under subparagraph "a" of paragraph 101 of these Rules) of the need to submit, via the applicant's unified personal account, to the registering authority, in accordance with the requirements of paragraph 53 of these Rules, an application for the registration of the domestic medical device. The application must be prepared in accordance with paragraph 64 of these Rules and additionally include the details of the conclusion on the results of the examination of the quality, efficacy, and safety of the domestic medical device issued by the institution. The application for the registration of the domestic medical device must be submitted within 30 business days from the date the institution sends the notification provided in this paragraph.

108. Within 5 business days from the date of receipt of the application for the registration of the domestic medical device, the registering authority shall verify the completeness and accuracy of the information contained therein, including by comparing such information with data provided by government authorities in the framework of interdepartmental information interaction through the interdepartmental electronic interaction system.

109. Within 5 business days from the date of completion of the verification specified in paragraph 108 of these Rules:

a) if the application for the registration of the domestic medical device is duly completed, the registering authority shall decide on the state registration of the medical device. This decision is formalized by an order of the registering authority, and the applicant is informed of the decision by placing a corresponding notification in the form of an electronic document signed with a qualified electronic signature of an authorized official in the applicant's unified personal account and personal account. The registering authority shall also make an entry in the state register;

b) if the application for the registration of the domestic medical device contains inaccurate information or if the information specified in paragraph 64 of these Rules is incomplete, the registering authority shall decide to cease further consideration of the application for the registration of the domestic medical device and shall inform the applicant by placing a corresponding notification with a reasoned justification for the decision in the form of an electronic document signed with a qualified electronic signature of an authorized official in the applicant's unified personal account and personal account.

 

V. Making Amendments to the Documents Contained in the Registration Dossier That Do Not Require an Examination of the Quality, Efficacy, and Safety of the Medical Device

 

110. Changes to the documents contained in the registration dossier that require the state registration of a new medical device include:

a) changes resulting in alterations to the functional purpose and/or principle of operation of the medical device;

b) inclusion of information on models (brands) of the registered medical device that do not meet the criteria specified in paragraph 26 of these Rules;

c) changes leading to simultaneous modifications of the information about the manufacturer and the production site(s) relative to the information specified in the registry entry, except for changes in the legal form, address of location, reorganization, or other details contained in the constituent documents.

111. Changes made to the documents contained in the registration dossier that do not require an examination of the quality, efficacy, and safety of the medical device include:

a) updates to the validity periods of documents contained in the registration dossier (updating of documents in the registration dossier by the applicant);

b) changes made by the manufacturer of medical devices of potential risk class 1 or non-sterile medical devices of potential risk class 2a, which have undergone quality management system evaluations, including processes for the design and development of medical devices, in accordance with the requirements for the implementation, maintenance, and evaluation of the quality management system for medical devices (excluding changes requiring the state registration of a new medical device in accordance with paragraph 110 of these Rules).

In cases where the validity period of the inspection report for the production of medical devices of potential risk class 1 or non-sterile medical devices of potential risk class 2a has expired, the application for changes to the documents contained in the registration dossier is considered based on the grounds specified in subparagraphs "a," "c"–"f" of this paragraph and paragraph 119 of these Rules;

c) changes in the information about the manufacturer of the medical device, including details regarding:

reorganization of a legal entity;

changes to the names of the legal entity (full and abbreviated, including trade names), or address of its location;

changes to the last name, first name, and patronymic (if applicable), address of residence of an individual registered as an individual entrepreneur, and the details of the document confirming their identity;

changes to the address(es) of the production site(s) if the change is due to the renaming of a geographical object, street, square, or other area, or changes to the numbering of address objects, including postal codes;

d) changes in the information about the authorized representative of the manufacturer, including details regarding:

reorganization of a legal entity;

changes to the name of the legal entity (full and abbreviated, including trade names, if applicable) or the address of its location;

changes to the last name, first name, and patronymic (if applicable), address of residence of an individual registered as an individual entrepreneur, and the details of the document confirming their identity;

e) changes to the name of the medical device concerning the trademark and other means of individualization;

f) exclusion of information about a model (brand) of the medical device from the registry entry;

g) changes to the design of the marking without altering the symbols used for marking the medical device;

h) changes to the classifier code in the event of a new edition of the classifier being issued after the decision on state registration of the medical device or changes to the documents contained in the registration dossier.

112. To amend the documents contained in the registration dossier as specified in paragraph 111 of these Rules, the applicant shall, no later than 90 business days from the date of the corresponding changes, submit the following to the registering authority via the applicant's unified account:

a) an application to amend the documents contained in the registration dossier, which do not require an examination of the quality, effectiveness, and safety of the medical device. The application must include the information specified in paragraph 64 of these Rules and additional information on the proposed changes, as well as (if applicable) information on the results of clinical trials of the medical device, specifying the number and date of the act of assessment of the clinical trial results and the name of the medical organization;

b) a copy (copies) of the document(s) confirming the authority of the authorized representative of the manufacturer (producer) to represent the interests of the manufacturer (producer), to bear responsibility for the circulation of the medical device within the Russian Federation, including matters related to conformity assessment procedures and state registration of the medical device, as well as to certify the document(s) of the manufacturer (producer) that took effect before the relevant documents were formalized. This document (these documents) is (are) mandatory for foreign manufacturers (producers) and may be submitted by domestic manufacturers (producers) if they have an authorized representative;

c) the documents specified in paragraph 65 of these Rules, which have been amended, and evidence showing that these changes do not affect the properties and characteristics of the medical device that influence its safety, quality, and effectiveness, or improve its properties and characteristics without altering the functional purpose and/or operating principle of the medical device;

d) copies of reports on the results of production inspections (in the case specified in subparagraph "b" of paragraph 111 of these Rules):

copies of documents confirming compliance of the quality management system with the requirements for implementing, maintaining, and evaluating the quality management system for medical devices (if the inspection was conducted by an inspection organization under the authority of the registering body) (submitted at the applicant's discretion);

copies of documents confirming compliance of the quality management system with the requirements for implementing, maintaining, and evaluating the quality management system for medical devices (submitted if the inspection was conducted by an inspection organization under the authority of a state body of a member state of the Eurasian Economic Union, authorized to perform and/or coordinate activities related to the circulation of medical devices in that state, excluding the Russian Federation).

113. The registering authority is not entitled to require the applicant to include information or submit documents in the application for amending the documents contained in the registration dossier that do not require an examination of the quality, effectiveness, and safety of the medical device, beyond those specified in paragraph 112 of these Rules.

The applicant may, at their discretion, submit other documents justifying the amendments that do not result in changes to the properties and characteristics of the medical device affecting its safety, quality, and effectiveness, or that improve its properties and characteristics without altering the functional purpose and/or operating principle of the medical device.

The procedure for amending the documents contained in the registration dossier that do not require an examination of the quality, effectiveness, and safety of the medical device shall be carried out by the registering authority within a period not exceeding 18 business days from the date of receipt of the application for amending the documents contained in the registration dossier and the documents specified in paragraph 112 of these Rules.

114. Within 5 business days from the date of receipt of the application for amending the documents contained in the registration dossier that do not require an examination of the quality, effectiveness, and safety of the medical device, and the documents specified in paragraph 112 of these Rules, the registering authority shall verify the completeness and accuracy of the information contained therein, including by comparing such information with data provided by state authorities through interagency electronic interaction systems.

115. If the application for amending the documents contained in the registration dossier that do not require an examination of the quality, effectiveness, and safety of the medical device is submitted in violation of paragraph 64 and subparagraph "a" of paragraph 112 of these Rules, and/or the submitted documents are formatted in violation of paragraphs 53–55 of these Rules, and/or the application and submitted documents contain inaccurate information, and/or the documents specified in paragraph 112 of these Rules are incomplete, the registering authority shall notify the applicant of the need to correct the identified violations and/or provide missing documents within 30 business days from the date of posting such notification in the form of an electronic document signed with a qualified electronic signature of an authorized official, in the applicant's unified account and electronic account. The applicant shall address the identified violations and/or provide missing documents through the unified account.

The time from the date the registering authority notifies the applicant to the date of receipt of the response to the notification or the notification of non-response is not included in the calculation of the timeline for the procedure for amending the documents contained in the registration dossier.

116. If the identified violations are not corrected and/or the missing documents are not provided within the period not exceeding 30 business days, including as specified in paragraph 53 of these Rules, the registering authority shall decide to terminate further consideration of the application for amending the documents contained in the registration dossier that do not require an examination of the quality, effectiveness, and safety of the medical device, with a justified explanation of the reasons for this decision.

117. Within 3 business days from the completion of the verification specified in paragraph 114 of these Rules (in the case of submission of a properly formatted application for amending the documents contained in the registration dossier that do not require an examination of the quality, effectiveness, and safety of the medical device, and a full set of documents as provided in paragraph 112 of these Rules), as well as in the case of elimination of identified violations and/or submission of documents specified in paragraph 112 of these Rules within the 30-business-day period, the registering authority shall decide to initiate the procedure for amending the documents contained in the registration dossier.

118. Within a period not exceeding 10 business days from the date of the decision to initiate the procedure for amending the documents contained in the registration dossier, the registering authority shall carry out the following actions:

a) issue a decision to amend the documents contained in the registration dossier, formalized by an order of the registering authority, and notify the applicant of the decision by placing the corresponding notification in the form of an electronic document signed with a qualified electronic signature of an authorized official in the applicant's unified account and electronic account;

b) make amendments to the registry record.

 

VI. Amendments to Documents Contained in the Registration Dossier Requiring an Examination of the Quality, Effectiveness, and Safety of the Medical Device

 

119. Amendments to the documents contained in the registration dossier, except in cases specified in paragraph 111 of these Rules, shall be made based on the results of examining the quality, effectiveness, and safety of the medical device.

120. To amend the documents contained in the registration dossier, as specified in paragraph 119 of these Rules, the applicant, within 90 business days from the date of the change in the relevant data, shall submit the following to the registering authority via the applicant's unified account:

a) an application for amending the documents contained in the registration dossier requiring an examination of the quality, effectiveness, and safety of the medical device, containing the information specified in paragraph 64 of these Rules and additionally including information about the amendments being made and, where applicable, information on the results of clinical trials of the medical device, including the number, date of the act of evaluating the results of the clinical trials of the medical device, and the name of the medical organization;

b) a copy (copies) of the document(s) confirming the authority of the authorized representative of the manufacturer (producer) to represent the interests of the manufacturer (producer), to bear responsibility for the circulation of the medical device within the territory of the Russian Federation, including matters related to conformity assessment procedures and state registration, as well as to certify the document(s) of the manufacturer (producer) effective before the formalization of the corresponding documents (the document(s) is mandatory for foreign manufacturers (producers); for domestic manufacturers (producers), it is provided if an authorized representative of the manufacturer (producer) is present);

c) documents confirming the possibility of manufacturing at the address(es) specified in the registration application as the production site(s), if applicable: documents confirming the availability of manufacturing conditions, and/or copies of certificates of compliance of the quality management system with the requirements of GOST ISO 13485-2017 or ISO 13485:2016, as well as copies of reports from previous inspections for compliance with these standards (if such certificates of compliance are provided), and/or copies of documents confirming the quality management system's compliance with the requirements for implementing, maintaining, and evaluating the quality management system for medical devices (provided in cases of inspections conducted by an inspection body under the jurisdiction of a state authority of a Eurasian Economic Union member state, excluding the Russian Federation);

d) documents specified in paragraph 65 of these Rules that have undergone relevant changes and confirm that the amendments do not lead to changes in the properties and characteristics of the medical device affecting its safety, quality, and effectiveness, or enhance its properties and characteristics without altering the functional purpose and/or operating principle of the medical device.

The applicant may, at their discretion, submit other documents justifying amendments that do not lead to changes in the properties and characteristics of the medical device affecting its safety, quality, and effectiveness, or that enhance its properties and characteristics without altering the functional purpose and/or operating principle of the medical device.

121. The registering authority is not entitled to require the applicant to include in the application for amendments to the documents contained in the registration dossier requiring an examination of the quality, effectiveness, and safety of the medical device any information or documents not specified in paragraph 120 of these Rules.

122. Within 5 business days from the receipt of the application for amendments to the documents contained in the registration dossier requiring an examination of the quality, effectiveness, and safety of the medical device, and the documents specified in paragraph 120 of these Rules, the registering authority verifies the completeness and accuracy of the information contained therein, including by comparing it with information provided by government authorities under interagency information exchange through the interagency electronic interaction system.

123. If the application for amendments to the documents contained in the registration dossier requiring an examination of the quality, effectiveness, and safety of the medical device is prepared in violation of the provisions of paragraph 64 and subparagraph "a" of paragraph 120 of these Rules, and/or the submitted documents violate the provisions of paragraphs 53–55 of these Rules, and/or the application and submitted documents contain inaccurate information, and/or the documents specified in paragraph 120 of these Rules are incomplete, the registering authority notifies the applicant of the need to eliminate the identified violations and/or provide missing documents within 30 business days from the posting of such notification as an electronic document signed with a qualified electronic signature of an authorized official in the applicant's unified account and electronic account. The applicant must address the identified violations and/or submit the missing documents via the unified account.

The time from the notification by the registering authority to the receipt of a response or notification of no response from the applicant is not included in the timeframe for the procedure for amendments to the documents contained in the registration dossier.

124. Within 3 business days from the completion of the verification specified in paragraph 122 of these Rules (in the case of a properly prepared application for amendments to the documents contained in the registration dossier requiring an examination of the quality, effectiveness, and safety of the medical device, and a complete set of documents as specified in paragraph 120 of these Rules), as well as in the case of rectification of identified violations and/or submission of documents specified in paragraph 120 of these Rules within the 30-business-day period, the registering authority decides to initiate the procedure for amendments to the documents contained in the registration dossier.

125. If, within 30 business days, the identified violations are not rectified and/or the missing documents are not submitted, including taking into account the provisions of paragraph 53 of these Rules, the registering authority decides to terminate further consideration of the application for amendments to the documents contained in the registration dossier requiring an examination of the quality, effectiveness, and safety of the medical device, and the documents specified in paragraph 120 of these Rules, and informs the applicant by posting the corresponding notification, with a reasoned justification for the decision, as an electronic document signed with a qualified electronic signature of an authorized official in the applicant's unified account and electronic account.

126. Amendments to the documents contained in the registration dossier requiring an examination of the quality, effectiveness, and safety of the medical device are carried out by the registering authority within 36 business days from the receipt of the application for amendments to the documents contained in the registration dossier requiring an examination of the quality, effectiveness, and safety of the medical device, and the documents specified in paragraph 120 of these Rules.

127. Within 3 business days from the decision to initiate the procedure for amendments to the documents contained in the registration dossier, the registering authority prepares and issues a task for an examination to the expert institution.

128. The examination of the application for amendments to the documents contained in the registration dossier requiring an examination of the quality, effectiveness, and safety of the medical device, and the documents specified in paragraph 120 of these Rules, is carried out simultaneously with the examination of the completeness and results of tests and studies within 15 business days from the receipt of the task by the expert institution from the registering authority.

129. During the examination of the quality, effectiveness, and safety of the medical device, the expert institution is not allowed to request materials necessary for the examination from the applicant or other persons.

If the materials and information contained in the application for amendments to the documents included in the registration dossier, requiring an examination of the quality, effectiveness, and safety of the medical device, as well as in the documents specified in paragraph 120 of these Rules, submitted by the applicant, are insufficient for the expert to draw a conclusion, the expert raises the issue of providing the necessary materials and information to the head of the expert institution. The head of the expert institution then submits the corresponding request to the registering authority that issued the task for the examination. This request must include a comprehensive list of all questions, materials, and information required by the expert to conduct the examination.

The registering authority, within 2 business days from the date of receipt of the request from the head of the expert institution, sends the applicant a request for the provision of the necessary information, indicating the nature of the comments and the method for their correction. This request is sent only once in the form of an electronic document signed with a qualified electronic signature of the authorized official, by placing it in the applicant's electronic account and unified personal account.

The applicant is required to respond to the request from the registering authority via the unified personal account within 50 business days from the date of sending the request. Within 2 business days of receiving the applicant's response to the request, the registering authority forwards this response to the expert institution. In the event of non-submission of the response by the applicant after 50 business days, the registering authority, within 2 business days, sends a notification to the expert institution about the applicant's failure to respond to the request. This notification is used to prepare a conclusion on the feasibility (or infeasibility) of introducing amendments to the documents included in the registration dossier, the format of which is approved by the Ministry of Health of the Russian Federation (hereinafter referred to as the conclusion on amendments to the documents included in the registration dossier), based on the documents available at its disposal.

The time from the date the registering authority sends the request to the date the response to the request or notification of non-response is received is not included when calculating the timeframe for conducting the examination of the quality, effectiveness, and safety of the medical device.

If the registering authority identifies inaccurate and/or insufficient data or documents presented by the applicant in response to the request, or inconsistencies in the format of the presented documents with the provisions of points 53–55 of these Rules, the registering authority, within 2 business days, sends the applicant (in the form of an electronic document signed with an enhanced qualified electronic signature of the authorized official and placed in the unified personal account and the electronic account of the applicant) a reasoned decision on the possibility of resubmission by the applicant of revised documents within 50 business days from the date of the request. If the applicant fails to submit the requested documents and information within the specified period, the examination of the quality, effectiveness, and safety of the medical device continues based on the documents and information previously provided by the applicant and contained in the registration dossier.

130. The expert institution, within 15 business days from the date of receipt of the documents specified in paragraph 120 of these Rules, conducts the examination provided for in paragraph 127 of these Rules and submits the conclusion on amendments to the documents included in the registration dossier to the registering authority.

131. The grounds for the expert institution to issue a conclusion on amendments to the documents included in the registration dossier, indicating the infeasibility of making amendments, are as follows:

a) inaccuracy of the information provided to justify the amendments, including inaccuracies identified by the registering authority based on the results of state control (supervision) over the circulation of medical devices;

b) absence in the documents submitted by the applicant of information confirming that the proposed amendments to the documents included in the registration dossier do not alter the properties and characteristics affecting the quality, effectiveness, and safety of the medical device, or improve its properties and characteristics while maintaining the functionality and/or principle of operation;

c) lack of information confirming the unchanged functionality and/or principle of operation of the medical device due to the proposed amendments to the documentation;

d) the necessity to conduct a new state registration of the medical device in accordance with paragraph 110 of these Rules;

e) existence of inaccurate information in the documents included in the registration dossier.

132. Within 10 business days from the date of receipt of the conclusion on amendments to the documents included in the registration dossier, the registering authority undertakes the following actions:

a) evaluates the conclusion on amendments to the documents included in the registration dossier to determine compliance with the assignment for the examination. If the conclusion does not comply with the specified assignment, it is returned to the expert institution for revision, which must be completed within 2 business days from the date the expert institution receives the returned conclusion;

b) in the case of receiving the conclusion on amendments to the documents included in the registration dossier as provided in paragraph 131 of these Rules, no later than the next business day after evaluating such a conclusion to determine compliance with the task for conducting the examination, the registering authority places an electronic copy of this conclusion in the applicant's electronic account and sends the corresponding information to the applicant's unified personal account.

Within 10 business days from the date the conclusion on amendments to the documents contained in the registration dossier, specified in paragraph 131 of these Rules, is posted in the applicant's electronic account, the applicant has the right to review the conclusion and, if objections exist, submit them via the electronic account.

If the applicant's objections to the conclusion specified in paragraph 131 of these Rules are submitted via the electronic account within a period not exceeding 10 business days, the registering authority reviews them within 30 business days from the date of receipt, involving the expert institution that issued the conclusion. If objections are not received within the established period, the registering authority undertakes the measures specified in subparagraphs "v" and "g" of this paragraph. When reviewing objections, the registering authority involves the applicant if clarifications are necessary.

Based on the results of the review of objections, a decision is made to recognize the objections as fully or partially justified, which is formalized in a letter from the registering authority and sent to the expert institution along with the conclusion on making changes to the documents contained in the registration dossier, as provided for in paragraph 131 of these Rules, for revision, the period for which shall not exceed 5 business days from the date the expert institution receives the returned conclusion on making changes to the documents contained in the registration dossier, or to recognize the objections as fully unjustified.

The period from the day the registering authority places the conclusion on amendments to the documents contained in the registration dossier, as specified in paragraph 131 of these Rules, in the applicant's electronic account until the decision based on the consideration of objections is made shall not be included in the calculation of the timeframe for conducting the examination of the quality, safety, and effectiveness of the medical device;

c) making a decision on the possibility (or impossibility) of amending the documents contained in the registration dossier, which is formalized by an order of the registering authority, and notifying the applicant of the decision made by sending a corresponding notification in the form of an electronic document signed with the enhanced qualified electronic signature of an authorized official or by placing it in the unified personal account of the applicant and the applicant's electronic account;

d) introducing amendments to the register entry (if a decision on the possibility of amending the documents contained in the registration dossier has been made).

133. The grounds for making a decision to refuse amendments to the documents contained in the registration dossier are:

a) receipt by the registering authority from the expert institution of a conclusion on amendments to the documents contained in the registration dossier indicating the impossibility of amending the documents contained in the registration dossier and/or the registering authority's decision to recognize the applicant's objections as fully or partially unjustified;

b) identification by the registering authority, based on the results of federal state control (supervision) over the circulation of medical devices, of discrepancies between the data on the effectiveness and safety of the medical device and the data on the medical device contained in the application for amendments to the documents in the registration dossier requiring the conduct of an examination of the quality, safety, and effectiveness of the medical device, and the documents specified in paragraph 120 of these Rules.

 

VII. Features of Making Amendments to the Documents Contained in the Registration Dossier for Software Utilizing Artificial Intelligence Technologies as a Medical Device

 

134. Amendments to the documents contained in the registration dossier for software utilizing artificial intelligence technologies as a medical device:

a) if the software utilizing artificial intelligence technologies as a medical device lacks a built-in function for automatic transmission, in a manner approved by the registering authority, to the registering authority's automated information system of data on processed information, results of the software's operation, and information stipulated by the procedure for reporting by entities involved in the circulation of medical devices on all cases of adverse effects, such amendments shall be carried out in accordance with paragraphs 110–133 of these Rules (if applicable);

b) regarding version numbering changes that do not affect the functional purpose and/or principle of operation of the software utilizing artificial intelligence technologies as a medical device, provided such software includes a built-in function for automatic transmission, in a manner approved by the registering authority, to the registering authority's automated information system of data on processed information, results of the software's operation, and information stipulated by the procedure for reporting by entities involved in the circulation of medical devices on all cases of adverse effects, such amendments shall be carried out in accordance with paragraphs 119–133 or 135 and 136 of these Rules.

135. To make amendments to the documents contained in the registration dossier for software utilizing artificial intelligence technologies as a medical device, specifically to update its version numbering without affecting its functional purpose and/or principle of operation, the applicant shall submit via the applicant's unified personal account to the registering authority an application for amending the documents contained in the registration dossier for software utilizing artificial intelligence technologies as a medical device, which must include the following information:

a) the name of the medical device;

b) information on the registration number and the date of state registration of the medical device (or the date of amendments to the documents contained in the registration dossier);

c) regarding the applicant: the full and abbreviated (if applicable) name, organizational and legal form, taxpayer identification number (if applicable), and the address of the location for a legal entity; or the surname, first name, patronymic (if applicable), identity document details, taxpayer identification number (if applicable), and residential address for an individual registered as an individual entrepreneur, as well as the phone number and email address of the legal entity or individual registered as an individual entrepreneur;

d) information about the version of the software utilizing artificial intelligence technologies as a medical device, which must be included in the state register;

e) information identifying the results of clinical trials of the software utilizing artificial intelligence technologies as a medical device (including the number, date of the act on clinical trials of the medical device, and the name of the medical organization);

f) information on the payment of the state fee (date and number of the payment order);

g) information on the applicant’s responsibility for the accuracy and consistency of the information contained in the registration dossier and the application for amending the documents contained in the registration dossier for the software utilizing artificial intelligence technologies as a medical device.

136. Within 5 business days from the date of receipt of the application for amending the documents contained in the registration dossier for the software utilizing artificial intelligence technologies as a medical device, the registering authority conducts a review of the completeness and accuracy of the information contained therein, including by comparing such information with data provided by government authorities under the framework of interdepartmental information interaction through the interdepartmental electronic interaction system. Within 5 business days after completing the review:

a) if the submitted application for amending the documents contained in the registration dossier for the software utilizing artificial intelligence technologies as a medical device is properly completed, the registering authority adopts a decision on amending the documents contained in the registration dossier. This decision is formalized by an order of the registering authority, and the applicant is informed of the decision by posting an appropriate notification in the form of an electronic document signed with the enhanced qualified electronic signature of an authorized official in the applicant’s unified personal account and electronic personal account. The registering authority also makes changes to the register entry;

b) If the submitted application for amending the documents contained in the registration dossier for the software utilizing artificial intelligence technologies as a medical device contains inaccurate information or the information required under paragraph 135 of these Rules is not provided in full, the registering authority adopts a decision to terminate further consideration of the application for amending the documents contained in the registration dossier for the software utilizing artificial intelligence technologies as a medical device. The registering authority informs the applicant of this decision by posting an appropriate notification, including a reasoned justification for the adoption of such a decision, in the form of an electronic document signed with the enhanced qualified electronic signature of an authorized official in the applicant’s unified personal account and electronic personal account.

 

VIII. Revocation of the State Registration of a Medical Device

 

137. The registering authority shall adopt a decision to revoke the state registration of a medical device in the following cases:

a) Submission by the applicant, via the applicant's unified personal account, of an application for the revocation of the state registration of the medical device, containing the information specified in paragraph 138 of these Rules;

b) issuance of a court decision confirming the violation of the rights of the intellectual property owner regarding the results of intellectual activity and equivalent means of individualization in the circulation of medical devices (or their models/brands);

c) submission by the federal executive authority authorized by the Government of the Russian Federation of information, based on the results of federal state control (oversight) over the circulation of medical devices, confirming facts and circumstances that pose a threat to the life and health of citizens and healthcare workers during the use and operation of medical devices;

d) identification by the registering authority, based on the results of federal state control (oversight) over the circulation of medical devices, of inaccurate information in the documents contained in the registration dossier submitted by the applicant, which affected the results of the quality, effectiveness, and safety examination of the medical device;

e) Receipt by the registering authority of a conclusion from the expert institution stating that the instrument, apparatus, device, equipment, material, and other items listed in the state register, based on their functional purpose and/or principle of operation, cannot be used for medical purposes and/or do not constitute medical devices. The conclusion from the expert institution stating that the instrument, apparatus, device, equipment, material, and other items listed in the state register, based on their functional purpose and/or principle of operation, cannot be used for medical purposes and/or do not constitute medical devices shall be submitted (sent) by the expert institution to the registering authority within 10 business days from the date of receipt by the expert institution of the corresponding assignment from the registering authority, accompanied by the documents contained in the registration dossier.

In the event that the registering authority receives a conclusion from the expert institution indicating that an instrument, apparatus, device, equipment, material, or other items may be used for medical purposes and/or classified as a medical device after amendments are made to the documents contained in the registration dossier, and/or indicating that the decision on the impossibility of using the instrument, apparatus, device, equipment, material, or other items for medical purposes and/or their classification as medical devices applies only to certain registered models (brands) of the medical device, the registering authority, prior to adopting a decision to revoke the state registration of the medical device, shall:

notify the applicant by placing the corresponding notification in the form of an electronic document signed with the enhanced qualified electronic signature of an authorized official in the applicant's electronic account. The notification shall include the expert institution's conclusion stating that the instrument, apparatus, device, equipment, material, or other items listed in the state register, based on their functional purpose and/or principle of operation, cannot be used for medical purposes and/or are not medical devices. The notification will also specify the requirement to amend the documents contained in the registration dossier within a period not exceeding 180 business days from the date of the notification;

adopt a decision to suspend the state registration of the medical device for a period of 180 business days from the date the notification on the need to amend the documents in the registration dossier is sent;

f) failure to amend the documents contained in the registration dossier confirming the authority of the manufacturer's (producer's) authorized representative to represent the manufacturer (producer) and assume responsibility for the circulation of the medical device within the territory of the Russian Federation, including matters related to conformity assessment and state registration procedures as specified in subparagraphs "a" or "d" of paragraph 111 of these Rules, within 90 business days from the expiration date of the relevant document, or the absence of information in the registration dossier regarding the appointment of the manufacturer's (producer's) authorized representative within 90 business days from the effective date of the requirements specified in the second paragraph of paragraph 29 of these Rules.

Before adopting a decision to revoke the state registration of a medical device in the case outlined in the first paragraph of this subparagraph, the registering authority shall: adopt a decision to suspend the state registration of the medical device for a period of 90 business days from the expiration date of the document confirming the authority of the manufacturer's (producer's) authorized representative to represent the manufacturer (producer) and assume responsibility for the circulation of the medical device within the Russian Federation, including matters related to conformity assessment and state registration, or from the date specified in the second paragraph of paragraph 29 of these Rules; simultaneously notify all participants in the medical device circulation sector via an information letter published on the official website of the registering authority on the Internet and through the applicant's electronic account. Alternatively, the manufacturer (producer) of the medical device shall be notified of the need to update information regarding the authorized representative of the manufacturer (producer).

g) absence of information in the register of conclusions on compliance with the requirements for the implementation, maintenance, and assessment of the medical device quality management system regarding the conducted periodic (planned) inspections, or failure to amend the documents contained in the registration dossier in accordance with subparagraph "a" of paragraph 111 of these Rules within a period not exceeding 90 business days from the expiration date of the inspection report (for medical devices that have undergone initial production inspection, except for medical devices of potential risk class 1 and non-sterile medical devices of potential risk class 2a).

Before making a decision to revoke the state registration of a medical device under the conditions specified in the first paragraph of this subparagraph, the registering authority adopts a decision to suspend the state registration of the medical device for a period of 180 business days from the expiration date of the inspection report or from the issuance of a negative conclusion following periodic (planned) or unplanned inspections. Simultaneously, it notifies all participants in the medical device circulation sector via an information letter published on the official website of the registering authority on the Internet and through the applicant's personal account or by sending a notification to the manufacturer (producer) and the authorized representative of the manufacturer (producer) about the need to conduct a periodic (planned) or unplanned inspection;

h) detection by the registering authority of changes made to the documents contained in the registration dossier for software utilizing artificial intelligence technologies that is classified as a medical device, for reasons other than those specified in paragraph 135 of these Rules;

i) failure to submit to the registering authority a clinical monitoring report for the medical device in accordance with the procedure for reporting all cases of adverse effects by entities involved in the circulation of medical devices.

Before making a decision to revoke the state registration of a medical device under the conditions specified in the first paragraph of this subparagraph, the registering authority adopts a decision to suspend the state registration of the medical device for a period of 30 business days from the date established by the procedure for reporting all cases of adverse effects by entities involved in the circulation of medical devices. Simultaneously, it notifies all participants in the medical device circulation sector via an information letter published on the official website of the registering authority on the Internet and through the applicant's electronic account or by sending the applicant a notification about the need to submit a clinical monitoring report for the medical device;

j) detection by the registering authority of false information in the documents submitted by the applicant during the state registration procedure for the medical device;

k) classification of a previously registered medical device as one of the medical devices specified in paragraph 5 of part 5 of Article 38 of the Federal Law "On the Fundamentals of Health Protection of Citizens in the Russian Federation".

138. The application for revoking the state registration of a medical device, as specified in subparagraph "a" of paragraph 137 of these Rules, must include the following information:

a) name of the medical device (including the models (brands) of the medical device, their composition, and accessories necessary for the use of the medical device or its models (brands) as intended, if applicable);

b) regarding the manufacturer (producer) of the medical device: the full and abbreviated (if available) name (with transliteration), organizational and legal form, taxpayer identification number (if available), address of the location (for a legal entity), or surname, first name, and patronymic (if available), identity document details, taxpayer identification number (if available), address of residence (for an individual registered as an individual entrepreneur), as well as the phone number and email address of the legal entity or the individual registered as an individual entrepreneur;

c) regarding the authorized representative of the manufacturer (producer): the full and abbreviated (if available) name, organizational and legal form, taxpayer identification number, address of the location (for a legal entity), or surname, first name, and patronymic (if available), identity document details, taxpayer identification number, address of residence (for an individual registered as an individual entrepreneur), as well as the phone number and email address of the legal entity or the individual registered as an individual entrepreneur;

d) the date of state registration of the medical device (or amendments to the documents contained in the registration dossier) and its registration number;

e) information on the reasons for submitting the application for the revocation of the state registration of the medical device;

f) details of the applicant's responsibility for the accuracy and consistency of the information contained in the submitted documents and the application for the revocation of the state registration of the medical device.

139. The application for the revocation of the state registration of a medical device, as specified in subparagraph "a" of paragraph 137 of these Rules, may be submitted by the authorized representative of the manufacturer (producer) if the following conditions are met simultaneously:

a) the registration dossier contains a valid document confirming the authority of the authorized representative of the manufacturer (producer) to represent the interests of the manufacturer (producer), to bear responsibility for the circulation of the medical device on the territory of the Russian Federation, including matters related to conformity assessment procedures and state registration, as well as to certify documents of the manufacturer (producer), which took effect prior to the issuance of the relevant documents, or the submission of such a document to the registering authority in accordance with the requirements of paragraph 53 of these Rules together with the application for the revocation of the state registration of the medical device;

b) the following documents are submitted to the registering authority together with the application for the revocation of the state registration of the medical device:

a letter from the manufacturer (producer) confirming its intention to revoke the state registration of the medical device (in cases where the application for the revocation of the state registration of the medical device is submitted by the authorized representative of the manufacturer (producer));

a copy (or copies) of the document (or documents) confirming the authority of the authorized representative of the manufacturer (producer) to represent the interests of the manufacturer (producer), to bear responsibility for the circulation of the medical device on the territory of the Russian Federation, including matters related to conformity assessment procedures and state registration of the medical device, as well as to certify the document (or documents) of the manufacturer (producer), which took effect prior to the issuance of the relevant documents (if a valid document is absent from the registration dossier) (the document (or documents) is (are) mandatory for foreign manufacturers (producers); domestic manufacturers (producers) must submit them if an authorized representative of the manufacturer (producer) is present).

140. If the application for the revocation of the state registration of the medical device is submitted in violation of the requirements of paragraph 139 of these Rules, and/or the submitted documents are prepared in violation of the provisions of paragraphs 53–55 of these Rules, and/or the application for the revocation of the state registration of the medical device and the submitted documents contain inaccurate information, and/or the documents specified in paragraph 139 of these Rules are not submitted in full, the registering authority, within 7 business days from the date of receipt of such an application and documents, makes a decision to terminate further consideration of the application with a reasoned justification for the decision.

141. The registering authority, within 7 business days from the occurrence of one of the cases specified in paragraph 137 of these Rules, shall:

a) make a decision on the revocation of the state registration of the medical device;

b) enter a record of the revocation of the state registration into the state register;

c) inform the applicant about the revocation of the state registration of the medical device by placing the corresponding notification in the form of an electronic document, signed with an enhanced qualified electronic signature of the authorized official, in the unified personal account of the applicant and the electronic account of the applicant.

 

 

___________

 

 

 

 

 

 

 

 

 

 

 

APPENDIX

to the Rules for State Registration of Medical Devices

 

(Form)

 

Ministry of Health of the Russian Federation

 

ETHICS COUNCIL

 

Date of the Ethics Council meeting: ________ ____, 20__

 

CONCLUSION

on the ethical justification for conducting clinical trials
of a medical device

 

No.______ dated ________ ____, 20__

 

1. Name of the medical device (including accessories necessary for the intended use of the medical device)

______________________________________________________________________

2. Manufacturer of the medical device
______________________________________________________________________                                            (full and abbreviated name (if any),

______________________________________________________________________

legal form of the legal entity, address of its registered office, or full name, address of residence for an individual registered as a sole proprietor)

3. Applicant
______________________________________________________________________

4. Decision: ______________________________________________________________________

(information on the ethical justification for conducting

______________________________________________________________________

clinical trials of the medical device, reasons

______________________________________________________________________

for the decision regarding the impossibility of conducting

______________________________________________________________________

clinical trials of the medical device)

 

Chairperson of the Council	_____________________ (full name)	___________________ (signature)
Experts	_____________________ (full name)	___________________ (signature)

 

 

____________

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

APPENDIX

to the Resolution of the Government

of the Russian Federation

dated November 30, 2024, No. 1684

 

LIST

of Acts of the Government of the Russian Federation that have become invalid

 

1. Resolution of the Government of the Russian Federation dated December 27, 2012, No. 1416, "On Approval of the Rules for State Registration of Medical Devices" (Collection of Legislation of the Russian Federation, 2013, No. 1, Article 14).

2. Resolution of the Government of the Russian Federation dated October 17, 2013, No. 930, "On Amendments to the Resolution of the Government of the Russian Federation No. 1416 dated December 27, 2012" (Collection of Legislation of the Russian Federation, 2013, No. 43, Article 5556).

3. Resolution of the Government of the Russian Federation dated July 17, 2014, No. 670, "On Amendments to the Rules for State Registration of Medical Devices" (Collection of Legislation of the Russian Federation, 2014, No. 30, Article 4310).

4. Resolution of the Government of the Russian Federation dated February 10, 2017, No. 160, "On Amendments to the Resolution of the Government of the Russian Federation No. 1416 dated December 27, 2012" (Collection of Legislation of the Russian Federation, 2017, No. 8, Article 1233).

5. Resolution of the Government of the Russian Federation dated May 31, 2018, No. 633, "On Amendments to the Rules for State Registration of Medical Devices" (Collection of Legislation of the Russian Federation, 2018, No. 24, Article 3523).

6. Resolution of the Government of the Russian Federation dated March 18, 2020, No. 299, "On Amendments to the Rules for State Registration of Medical Devices" (Collection of Legislation of the Russian Federation, 2020, No. 12, Article 1792).

7. Resolution of the Government of the Russian Federation dated September 1, 2020, No. 1335, "On Amending Clause 2 of the Rules for State Registration of Medical Devices" (Collection of Legislation of the Russian Federation, 2020, No. 36, Article 5637).

8. Resolution of the Government of the Russian Federation dated November 24, 2020, No. 1906, "On Amending the Rules for State Registration of Medical Devices" (Collection of Legislation of the Russian Federation, 2020, No. 49, Article 7897).

 

 

___________

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

APPROVED

by Resolution of the Government

of the Russian Federation

dated November 30, 2024, No. 1684

 

AMENDMENTS

to be introduced into the Acts of the Government of the Russian Federation

 

1. In the Resolution of the Government of the Russian Federation dated December 31, 2020, No. 2467, "On the approval of the list of regulatory legal acts and groups of regulatory legal acts of the Government of the Russian Federation, regulatory legal acts, individual provisions of regulatory legal acts and groups of regulatory legal acts of federal executive authorities, legal acts, individual provisions of legal acts, groups of legal acts of executive and administrative authorities of the RSFSR and the USSR, decisions of the State Commission on Radio Frequencies containing mandatory requirements, in relation to which the provisions of Parts 1, 2, and 3 of Article 15 of the Federal Law 'On Mandatory Requirements in the Russian Federation' do not apply" (Collected Legislation of the Russian Federation, 2021, No. 2, Art. 471; 2022, No. 23, Art. 3785; 2024, No. 25, Art. 3505; No. 33, Art. 5163; No. 38, Art. 5651; No. 40, Art. 5981; No. 42, Art. 6257; No. 44, Art. 6619):

a) in paragraph 10, remove the digits "637."

b) in the list of regulatory legal acts and groups of regulatory legal acts of the Government of the Russian Federation, regulatory legal acts, individual provisions of regulatory legal acts and groups of regulatory legal acts of federal executive authorities, legal acts, individual provisions of legal acts, groups of legal acts of executive and administrative authorities of the RSFSR and the USSR, and decisions of the State Commission on Radio Frequencies containing mandatory requirements, to which the provisions of Parts 1, 2, and 3 of Article 15 of the Federal Law "On Mandatory Requirements in the Russian Federation" do not apply, exclude item 637.

2. In the second paragraph of item 6 of the changes introduced into the Resolution of the Government of the Russian Federation dated December 31, 2020, No. 2467, approved by the Resolution of the Government of the Russian Federation dated June 12, 2024, No. 792 "On Amending Certain Acts of the Government of the Russian Federation" (Collected Legislation of the Russian Federation, 2024, No. 25, Art. 3505), remove the digits "637".

___________ 

GOVERNMENT OF THE RUSSIAN FEDERATION

 

RESOLUTION

 

dated November 30, 2024, No. 1684

 

MOSCOW

 

On Approval of the Rules for State Registration of Medical Devices

 

The Government of the Russian Federation hereby resolves:

1. To approve the attached Rules for the State Registration of Medical Devices.

2. State registration of medical devices, including state registration of medical devices with a low degree of potential risk in their application, for which special conditions of state registration have been established, as well as amendments to the documents contained in the registration dossiers for medical devices, applications for which were submitted to the Federal Service for Surveillance in Healthcare prior to the effective date of this resolution, shall be carried out in accordance with the requirements of the rules for state registration of medical devices that were in force before the effective date of this resolution.

Registration certificates issued for medical devices that have undergone state registration based on an application submitted to the Federal Service for Surveillance in Healthcare prior to the effective date of the Rules approved by this resolution shall remain valid until amendments are made to the information contained in the registry entry of the state register of medical devices and organizations (individual entrepreneurs) engaged in the production and manufacture of medical devices.

3. Medical organizations that meet the requirements for medical organizations conducting clinical trials of medical devices, as approved in the prescribed manner, and that confirm such compliance by March 1, 2025, shall notify the Federal Service for Surveillance in Healthcare by sending a letter to the Service (on paper directly, by registered mail with acknowledgment of receipt, or as an electronic document signed with a qualified electronic signature or a non-qualified electronic signature, the verification key certificate of which is created and used within the infrastructure ensuring information and technological interaction of information systems used for the provision of state and municipal services in electronic form, as established by the Government of the Russian Federation, to the email address of the Federal Service for Surveillance in Healthcare) by September 1, 2025, regarding compliance with the requirements established by subparagraph "f" of paragraph 6 and/or subparagraph "e" of paragraph 7 of the Rules approved by this resolution.

4. To declare void the acts of the Government of the Russian Federation listed in the annex.

5. To approve the attached amendments to the acts of the Government of the Russian Federation.

6. The implementation of the powers provided for in this resolution shall be carried out by the Federal Service for Surveillance in Healthcare within the established limits of the maximum number of its employees determined by the Government of the Russian Federation, as well as the budget allocations provided to the Federal Service for Surveillance in Healthcare for leadership and management in the area of established functions.

7. This resolution shall enter into force on March 1, 2025, except for subparagraph "f" of paragraph 137 of the Rules approved by this resolution, which shall enter into force on September 1, 2025.

Paragraphs 1, 2, and 6 of this resolution and the Rules approved by this resolution shall remain in effect until December 31, 2026, except for paragraphs 63, 87, and 101 of the said Rules, which shall remain in effect until December 31, 2025.

 

 

Chairman of the Government
of the Russian Federation M. Mishustin

 

 

 

 

 

APPROVED

by the Resolution of the Government

of the Russian Federation

dated November 30, 2024, No. 1684

 

RULES
for the State Registration of Medical Devices

 

I. General Provisions

 

1. These Rules establish the procedure for the state registration of medical devices intended for circulation in the territory of the Russian Federation (hereinafter referred to as medical devices).

2. Subject to state registration are any instruments, apparatus, devices, equipment, materials, and other products used for medical purposes, either individually or in combination with one another, as well as with other accessories necessary for their intended use, including specialized software. Such devices are intended by the manufacturer (producer) for the prevention, diagnosis, treatment, and medical rehabilitation of diseases, monitoring the human body's condition, conducting medical research, restoring, replacing, altering anatomical structures or physiological functions of the body, or preventing or interrupting pregnancy, whose functional purpose is not realized through pharmacological, immunological, genetic, or metabolic effects on the human body.

Medical devices specified in Part 5 of Article 38 of the Federal Law "On the Fundamentals of Health Protection of Citizens in the Russian Federation" are not subject to registration in the territory of the Russian Federation.

3. State registration of medical devices is carried out by the Federal Service for Surveillance in Healthcare (hereinafter referred to as the registering authority).

4. The following key terms are used in these Rules:

"safety of medical devices" – the absence of unacceptable risk associated with harm to human life, health, and the environment;

"evidence materials of the manufacturer (producer) of a medical device" – evidence materials (documents) from the manufacturer (producer) of the medical device or another organization containing the results of tests to determine the quality and safety of the medical device, its compliance with the requirements of regulatory documentation, technical and operational documentation of the manufacturer (producer), and/or studies to assess the biological safety of the medical device. These materials also include justifications for selected methods, their validity, and the equipment used for testing;

"applicant" – the manufacturer (producer) of a medical device or an authorized representative of the manufacturer (producer);

"unified personal account of the applicant" – a subsystem of the unified personal account of the applicant in the federal state information system "Unified Portal of State and Municipal Services (Functions)";

"unified personal account of the medical organization" – a subsystem of the unified personal account of the medical organization in the federal state information system "Unified Portal of State and Municipal Services (Functions)";

"quality of medical devices" – the combination of properties and characteristics of a medical device that influence its ability to perform as intended, provided it complies with the requirements of regulatory documentation and the manufacturer’s (producer’s) technical and operational documentation. The intended purpose of a medical device is defined as the decision by the manufacturer (producer) regarding its target use based on its specific properties, ensuring achievement of medical application goals, and reflected in the manufacturer’s (producer’s) technical and operational documentation;

"clinical trials" – a designed and planned systematic study conducted, including the participation of a human as a subject, to evaluate the safety and effectiveness of a medical device;

"model (brand) of a medical device" – a version of a medical device characterized by specific design and technological solutions and specific performance indicators of its intended (functional) purpose;

"regulatory documentation" – a document establishing the requirements for safety, quality, as well as the expected effectiveness of the intended use and the methods for controlling the compliance of the medical device with these requirements. The set of information specified in the regulatory documentation is approved by the registering authority;

"accessory" – a product that is not a medical device, designated by its manufacturer for joint use with one or more medical devices in accordance with their intended purpose;

"manufacturer (producer) of a medical device" – a legal entity or an individual registered as an individual entrepreneur responsible for the development and manufacture of a medical device, making it available for use under their name, regardless of whether the medical device was developed and/or manufactured by this entity or on its behalf by another entity (entities), and bearing responsibility for the safety, quality, and effectiveness of the medical device;

"production site" – a geographically separate facility designed to perform the entire process of manufacturing a medical device or its specific stages. The specific stages of the production process include:

manufacturing the entire medical device or its main components, except for main components that are medical devices registered in accordance with established procedures in the Russian Federation, at geographically separate facilities that are part of the organizational structure of the manufacturer (producer) of the medical device;

manufacturing under contracts with an external manufacturer (contractor) the entire medical device or its main components, except for main components that are medical devices registered in accordance with established procedures in the Russian Federation;

sterilizing the medical device (for medical devices produced in sterile form);

labeling the medical device (when labeling is performed by the manufacturer (producer) of the medical device).

The main components refer to products, excluding spare parts of the medical device, released for circulation under the name of the manufacturer (producer) of the registered medical device, not mechanically connected to other main components of the medical device upon delivery, and ensuring the functioning of the medical device according to its intended purpose.

Buildings, structures, or premises designated as "residential" cannot serve as production sites for medical devices;

"registration dossier" – a set of documents submitted by the applicant for the state registration of a medical device, for making amendments to such documents, for canceling the state registration of a medical device, as well as copies of decisions made by the registering authority and the federal state budgetary institution under its jurisdiction (hereinafter referred to as the expert institution) concerning a specific medical device;

"registration number of a medical device" – a code assigned to a medical device upon its state registration, under which it is entered into the state register of medical devices and organizations (individual entrepreneurs) engaged in the production and manufacture of medical devices (hereinafter referred to as the state register), and which remains unchanged during the circulation of the medical device;

 

"technical documentation of the manufacturer (producer) of a medical device" – a document (or documents) defining the design of the medical device, establishing technical requirements, and containing data for its development, production, application, operation, maintenance, repair, disposal, or destruction;

"technical tests of a medical device" – tests conducted to determine the quality and safety of a medical device, to verify its characteristics (properties) comply with the requirements of regulatory, technical, and operational documentation of the manufacturer (producer), and to make subsequent decisions on the possibility of conducting clinical trials. These tests are performed in a testing laboratory (center) accredited in the national accreditation system, considering its scope of accreditation;

"toxicological studies of a medical device" – studies conducted to assess the biological safety of a medical device and to make subsequent decisions on the possibility of conducting clinical trials. These studies are performed in a testing laboratory (center) accredited in the national accreditation system, considering its scope of accreditation;

"authorized representative of the manufacturer (producer) of a medical device" – a legal entity or an individual registered as an individual entrepreneur, residing in the Russian Federation, authorized by the manufacturer (producer) of a medical device to represent its interests regarding the circulation of the medical device in the Russian Federation, including issues of conformity assessment procedures and state registration;

"operational documentation of the manufacturer (producer) of a medical device" – a document (or documents) intended to familiarize the consumer with the design of the medical device, regulating the conditions and rules of operation (intended use, maintenance, current repair, storage, and transportation). It includes guaranteed values of the main parameters and characteristics (properties) of the medical device, warranty obligations, and information on its disposal or destruction;

"applicant's electronic account " – a service within the automated information system of the registering authority in the information and telecommunication network "Internet" (hereinafter referred to as the Internet), enabling the applicant, after completing identification and authentication procedures, to interact with the registering authority and access information and documents contained in the registration dossier as provided for in these Rules;

"electronic document image" – a document in hard copy converted into electronic form through scanning, preserving its requisites;

"effectiveness of a medical device" – the ability of a medical device to fulfill the intended purpose established by the manufacturer (producer). The effectiveness of a medical device is confirmed through clinical application, including clinical trials.

5. State registration of medical devices, the effectiveness of which requires conducting clinical trials involving human participants and obtaining authorization from the registering authority for conducting clinical trials, shall be carried out in accordance with paragraphs 63–86 of these Rules.

State registration of medical devices, the effectiveness of which does not require conducting clinical trials involving human participants or obtaining authorization from the registering authority for conducting such clinical trials, shall be carried out in accordance with paragraphs 87–100 of these Rules.

Amendments to the documents contained in the registration dossier shall be made in accordance with paragraphs 112–118 of these Rules for amendments that do not require an examination of the quality, effectiveness, and safety of the medical device, and in accordance with paragraphs 120–133 of these Rules for amendments that require an examination of the quality, effectiveness, and safety of the medical device.

Amendments to the documents contained in the registration dossier for software using artificial intelligence technologies classified as a medical device shall be made in accordance with paragraphs 112–118, 120–133, or 135–136 of these Rules.

State registration of medical devices is conducted based on the results of technical tests, toxicological studies, clinical trials (which represent forms of conformity assessment of medical devices considering the classification depending on the potential risk of their use), production inspections, analysis of evidence materials from the manufacturer (producer) of the medical device, quality, effectiveness, and safety examinations of medical devices, as well as tests for the approval of the type of measuring instruments (for medical devices classified as measuring instruments in the field of state regulation of ensuring the uniformity of measurements, the list of which is approved by the Ministry of Health of the Russian Federation).

6. Clinical trials of medical devices (excluding in vitro diagnostic medical devices) are conducted in medical organizations that meet the following requirements:

a) possession of a license for medical activities indicating the list of works (services) constituting medical activities, based on the intended use and application area of the medical devices undergoing testing;

b) inclusion in the charter of the medical organization of the following types of activities:

scientific (research) activities;

conducting clinical trials of medical devices;

c) availability of an intensive care and resuscitation unit (ward) (if clinical trials involve human participants as subjects for devices classified as class 2b and class 3 depending on the potential risk of use);

d) ensuring the protection of confidential information;

e) availability of standard operating procedures regulating the conduct of clinical trials of medical devices, including:

qualification requirements and staff training;

interaction with the ethics committee;

obtaining informed consent;

procedures for conducting clinical trials;

maintenance and record-keeping of clinical trial documentation;

procedures related to the creation and verification of datasets for conducting clinical trials of software using artificial intelligence technologies classified as a medical device (if such trials are conducted);

f) ensuring the entry of data on conducted trials, including the issuance of an evaluation report on the clinical trial results, into the automated information system of the registering authority in accordance with the procedure established by the registering authority;

g) having specialists within the medical organization who directly conduct procedures related to clinical trials or make decisions related to clinical trials, with higher medical education in a specialty corresponding to the area of medical application of the medical device.

7. Medical organizations conducting clinical trials of in vitro diagnostic medical devices must meet the following requirements:

a) a license for medical activities in laboratory diagnostics and clinical laboratory diagnostics;

b) inclusion in the charter of the medical organization of the following types of activities:

scientific (research) activities;

conducting clinical trials of medical devices;

c) ensuring the protection of confidential information;

d) availability of standard operating procedures regulating the conduct of clinical trials of medical devices, including:

qualification requirements and staff training;

procedures for verification and calibration of equipment;

procedures for conducting clinical trials;

maintenance and record-keeping of clinical trial documentation;

e) ensuring the entry of data on conducted clinical trials, including the issuance of an evaluation report on the results of clinical trials of in vitro diagnostic medical devices, into the automated information system of the registering authority in accordance with the procedure established by the registering authority;

f) having specialists within the medical organization who directly conduct procedures related to clinical trials or make decisions related to clinical trials, with higher medical education or secondary professional medical education in a specialty corresponding to the area of medical application of the medical device.

8. Determination of the compliance of a medical organization with the requirements of paragraphs 6 and/or 7 of these Rules is carried out by the registering authority to recognize the competence of the medical organization in conducting clinical trials of medical devices according to the relevant profile of medical care provided by the medical organization.

The registering authority maintains a list of medical organizations conducting clinical trials and publishes it on its official website on the Internet.

9. A medical organization intending to conduct clinical trials of medical devices shall submit to the registering authority, using the federal state information system "Unified Portal of State and Municipal Services (Functions)," an application for conducting clinical trials of medical devices and the documents specified in paragraph 11 of these Rules, in the form of electronic documents or electronic copies of documents signed with a qualified electronic signature or a non-qualified electronic signature, the verification key certificate of which is created and used in the infrastructure ensuring information and technological interaction of information systems used for the provision of state and municipal services in electronic form, as established by the Government of the Russian Federation (hereinafter referred to as the application for conducting clinical trials).

10. The application for conducting clinical trials must include the following information:

a) the full and abbreviated (if available) name, including the trade name, organizational and legal form of the medical organization, address of its location, as well as the telephone numbers and email addresses of the medical organization (if available);

b) details of the license for medical activities;

c) taxpayer identification number;

d) a list of works (services) in accordance with the license for medical activities;

e) information on the presence (or absence) of accreditation in the national accreditation system as a testing laboratory (center) and/or medical laboratory (for medical organizations conducting clinical trials of in vitro diagnostic medical devices);

f) information on the sanitary-epidemiological certificate (indicating the number and date) confirming compliance of the premises necessary for performing works (services) in anesthesiology and resuscitation with sanitary regulations (excluding medical organizations conducting clinical trials of in vitro diagnostic medical devices);

g) information on the sanitary-epidemiological certificate (indicating the number and date) confirming compliance of the premises necessary for performing works (services) in laboratory diagnostics, clinical laboratory diagnostics with sanitary regulations (for medical organizations conducting clinical trials of in vitro diagnostic medical devices);

h) information on the sanitary-epidemiological certificate confirming compliance of the conditions for handling biological substances, biological and microbiological organisms, and their toxins with sanitary regulations (for medical organizations conducting clinical trials of in vitro diagnostic medical devices);

i) details of documents confirming the compliance of specialists in the medical organization directly conducting procedures related to clinical trials or making decisions related to clinical trials with the requirements of subparagraph "g" of paragraph 6 and/or subparagraph "f" of paragraph 7 of these Rules, including the full names of specialists, dates of birth, education level, specialty name, series and number of the education document, its date, and the insurance individual account number.

11. To establish the compliance of medical organizations with the requirements for conducting clinical trials of medical devices, the medical organization must submit the following documents, certified by the medical organization in accordance with the established procedure:

a) copies of documents confirming the availability of an intensive care and resuscitation unit (ward) (in cases of clinical trials involving human participants as subjects for devices classified as class 2b and class 3 depending on the potential risk of use);

b) a copy of a document approved by the head of the medical organization establishing the bed capacity, structure, and staffing schedule of the medical organization;

c) copies of documents confirming the availability of a clinical-diagnostic (diagnostic) laboratory indicating its profile (for medical organizations conducting clinical trials of in vitro diagnostic medical devices);

d) a copy of a document approved by the head of the medical organization establishing the procedure for handling confidential information;

e) copies of standard operating procedures regulating the conduct of clinical trials of medical devices;

f) a copy of a document approved by the head of the medical organization establishing the procedure for transferring information about conducted clinical trials, including details of the issued evaluation report on clinical trial results, into the automated information system of the Federal Service for Surveillance in Healthcare;

g) copies of documents confirming the compliance of specialists in the medical organization directly conducting procedures related to clinical trials or making decisions related to clinical trials with the requirements of subparagraph "g" of paragraph 6 and/or subparagraph "f" of paragraph 7 of these Rules (to be submitted if the documents were obtained by specialists before 1992, issued by educational institutions belonging to the armed forces or military departments of the Russian Federation, or obtained abroad).

12. A medical organization may, at its own discretion, submit documents for which information is specified in the application for conducting clinical trials in accordance with paragraph 10 of these Rules.

The registering authority is not entitled to require the submission of documents and information that are in the possession of bodies providing state services, bodies providing municipal services, other state bodies, local self-government bodies, or organizations subordinate to state or local self-government bodies participating in the provision of state and municipal services.

The registering authority is not entitled to require the medical organization to submit documents not provided for in paragraph 11 of these Rules.

13. The documents specified in paragraph 11 of these Rules must be prepared in multicolor format with a resolution of at least 300 dots per inch in *.pdf format with a text layer allowing for the selection and copying of blocks, as well as for search functionality.

The size of any file containing the documents specified in this paragraph must not exceed 100 MB.

The application for conducting clinical trials and the documents submitted by the medical organization in accordance with paragraph 11 of these Rules are accepted and registered by the registering authority on the day of their receipt.

14. The registering authority shall, within a period not exceeding 20 business days from the date of receipt of the application for conducting clinical trials and the documents submitted by the medical organization in accordance with paragraph 11 of these Rules, review them, verify the completeness and accuracy of the information contained therein, and check the compliance of the medical organization with the requirements for medical organizations conducting clinical trials of medical devices as established by paragraphs 6 and/or 7 of these Rules.

Verification of the founding documents and the presence of a license for medical activities in the medical organization in accordance with the area of medical application of medical devices is carried out by the registering authority using the unified system of interdepartmental electronic interaction and its connected regional systems of interdepartmental electronic interaction or through an interdepartmental request by the registering authority.

15. The registering authority shall, within the period specified in paragraph 14 of these Rules, make a decision on the compliance or non-compliance of the medical organization with the requirements for medical organizations conducting clinical trials of medical devices, as established by paragraphs 6 and/or 7 of these Rules. This decision is formalized in an official resolution.

16. If a decision is made regarding the compliance of the medical organization with the requirements established by paragraphs 6 and/or 7 of these Rules, the registering authority, on the day the decision is made, includes information about the medical organization in the list of medical organizations conducting clinical trials of medical devices and informs the medical organization about its inclusion in the list by posting the corresponding notification in the unified personal account of the medical organization.

17. The list of medical organizations conducting clinical trials of medical devices includes the following information:

a) the date of inclusion in the list of medical organizations conducting clinical trials of medical devices;

b) the full name and organizational-legal form of the medical organization;

c) the address of the medical organization's location;

d) contact phone number and fax (if available);

e) e-mail address (if available);

f) the list of works (services) in accordance with the license for medical activities.

18. If a decision is made that the medical organization does not meet the requirements established by paragraphs 6 and/or 7 of these Rules, the registering authority shall, on the day of the decision, notify the medical organization by posting the corresponding notification with a reasoned explanation of the decision in the unified personal account of the medical organization.

19. Removal from the list of medical organizations conducting clinical trials of medical devices shall be carried out by the registering authority in the following cases:

a) submission of an application for removal from the list of medical organizations conducting clinical trials of medical devices in the form of an electronic document signed with a qualified electronic signature or a non-qualified electronic signature via the unified personal account of the medical organization;

b) identification by the registering authority of violations of mandatory requirements during the clinical trials of medical devices conducted by the medical organization based on the results of state control over the circulation of medical devices;

c) provision of inaccurate information by the medical organization when submitting an application for conducting clinical trials and documents in accordance with paragraph 11 of these Rules, as well as during the preparation of clinical trial reports for medical devices;

d) liquidation of the medical organization or termination of the license for medical activities;

e) failure to submit or untimely submission of the information and documents specified in paragraph 20 of these Rules;

f) failure to notify the registering authority by September 1, 2025, of compliance with the requirements established by subparagraph "f" of paragraph 6 and/or subparagraph "e" of paragraph 7 of these Rules. 

20. If there is a change in the information contained in the list of medical organizations conducting clinical trials of medical devices, the medical organization included in the list must, within 30 calendar days from the date of the change, submit an application to the registering authority using the unified personal account of the medical organization to update the information. The application must be accompanied by documents confirming the changes, in the form of electronic documents or electronic images of documents signed with a qualified electronic signature or a non-qualified electronic signature.

The registering authority, within 20 business days from the date of submission by the medical organization of an application to amend the information contained in the list of medical organizations conducting clinical trials of medical devices:

reviews the submitted application and documents;

notifies the medical organization of the decision in writing by posting it as an electronic document signed with a qualified electronic signature of an authorized official in the unified personal account of the medical organization.

21. If a medical organization is excluded from the list of medical organizations conducting clinical trials of medical devices (except in the case provided for in subparagraph "a" of paragraph 19 of these Rules), the medical organization has the right to reapply to the registering authority for conducting clinical trials after addressing the issues that led to the exclusion, but no earlier than three years from the date of exclusion from the list.

In the event of repeated violations identified by the registering authority during the clinical trials conducted by the medical organization, the organization will be excluded from the list of medical organizations conducting clinical trials of medical devices without the right to reapply for conducting clinical trials.

22. Medical organizations conducting clinical trials of medical devices must enter information about the completed trials into the automated information system of the registering authority within three business days of their completion.

23. The register of issued permits for conducting clinical trials of medical devices is published by the registering authority in the manner established by it on its official website on the Internet.

24. Special conditions for the state registration of domestically manufactured medical devices (medical devices for which the manufacturer (producer) indicated in the registration application (hereinafter referred to as the registration application) is a legal entity or an individual entrepreneur residing in the Russian Federation and having a production site located in the Russian Federation) are provided under the following conditions: technical and toxicological tests of the medical device are conducted, as well as tests for type approval of measuring instruments (for medical devices classified as measuring instruments within the state regulation of ensuring measurement uniformity, the list of which is approved by the Ministry of Health of the Russian Federation) are carried out at the Federal State Budgetary Institution "All-Russian Scientific Research and Testing Institute of Medical Technology" of the Federal Service for Surveillance in Healthcare (hereinafter referred to as the institution), clinical trials are conducted in medical organizations that meet the requirements of paragraphs 6 and 7 of these Rules, are included in the network of national medical research centers approved by the Ministry of Health of the Russian Federation, and for software using artificial intelligence technologies intended for processing medical images obtained from radiological studies, including computed tomography, X-ray imaging, fluorography, and mammography. Clinical trials for such software must be conducted at the State Budgetary Healthcare Institution of the City of Moscow "Scientific and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Healthcare Department" (hereinafter referred to as the clinical center, domestic medical devices), as specified in paragraphs 101–109 of these Rules.

State registration of domestically manufactured medical devices is carried out in accordance with paragraphs 63–86 or 87–100 of these Rules, or in accordance with the special conditions for the state registration of domestically manufactured medical devices established by paragraphs 101–109 of these Rules, at the discretion of the applicant.

25. The fact of state registration of a medical device in accordance with these Rules is confirmed by a registry entry made by the registering authority in the state register (hereinafter referred to as the registry entry).

State registration of a medical device in accordance with these Rules is perpetual.

26. The inclusion of several models (brands) of a medical device in one registry entry, including those belonging to different types of medical devices according to the nomenclature classification of medical devices by type approved by the Ministry of Health of the Russian Federation (hereinafter referred to as the nomenclature classification of medical devices by type), is possible provided that these models (brands) meet all the following criteria:

a) the production of models (brands) of the medical device is carried out by one manufacturer (producer) in accordance with one technical documentation of the manufacturer (producer);

b) the models (brands) of the medical device belong to the same class of potential risk of use;

c) the models (brands) of the medical device have the same functional purpose and principle of operation;

d) the models (brands) of the medical device are intended to determine the presence and/or quantitative content in a biological sample of the same clinically (diagnostically) significant analyte(s) (for in vitro diagnostic medical devices);

e) the models (brands) of the medical device have different configurations that do not affect the principle of operation and functional purpose, allowing for the expansion or specialization of their use for medical purposes (if applicable);

f) the models (brands) of the medical device have different technical parameters that do not affect the principle of operation and functional purpose (if applicable);

g) the models (brands) of the medical device form a size range (model series) or constitute a group of implementations of the medical device. A group of implementations of the medical device refers to products for which a single group drawing of parts and/or one technical documentation of the manufacturer (producer) for the medical device has been developed;

h) the models (brands) of the medical device have the same characteristics regarding:

area of application;

invasiveness;

sterility (including sterilization methods);

frequency of use (single-use, multiple-use by one patient, multiple-use by multiple patients);

operational and design features.

27. The state fee for actions performed by the registering authority in the course of state registration of medical devices is paid in accordance with the legislation of the Russian Federation on taxes and fees.

The registering authority obtains information about the payment of the state fee through access to the State Information System on State and Municipal Payments as provided for by Article 21³ of the Federal Law "On the Organization of the Provision of State and Municipal Services."

28. The registering authority publishes information related to the state registration of a medical device, amendments to the documents contained in the registration dossier, and the cancellation of state registration on its official website on the Internet, in the unified personal account of the applicant, and in the applicant's electronic account.

29. For the purpose of completing the state registration procedure for a medical device, a foreign manufacturer (producer) of the medical device must appoint an authorized representative of the manufacturer (producer) who will act during the circulation of the medical device in the territory of the Russian Federation and ensure that the information about such a representative in the registration dossier is kept up-to-date.

If information about the authorized representative of the manufacturer (producer) is not specified in the documents contained in the registration dossier or is outdated, the foreign manufacturer (producer) must, by September 1, 2025, appoint an authorized representative of the manufacturer (producer) who will act during the circulation of the medical device in the territory of the Russian Federation or update the information about them.

30. Before submitting an application to the registering authority for the registration of a medical device or for making amendments to the documents contained in the registration dossier in accordance with paragraphs 63, 87, 112, 120, and 135 of these Rules or submitting an application to the institution for the examination of the quality, effectiveness, and safety of a domestically manufactured medical device in accordance with paragraph 101 of these Rules, the applicant must collect evidence of the safety and effectiveness of the medical device and prepare the corresponding documents for the registration dossier.

31. For the purpose of preparing the documents contained in the registration dossier for subsequent submission to the registering authority or the institution, the applicant (as applicable, depending on the procedure):

a) ensures the conduct of technical tests and/or includes existing data (evidence materials from the manufacturer (producer) of the medical device) in the document set;

b) ensures the conduct of toxicological studies of the medical device and/or accessories to the medical device that directly or indirectly come into contact with the human body's surface, mucous membranes, or internal environments, where such interaction (contact) is necessary for the performance of their intended functions, and/or includes existing data (evidence materials from the manufacturer (producer) of the medical device) in the document set;

c) ensures the conduct of clinical trials of the medical device (excluding the state registration of medical devices, for which the confirmation of effectiveness requires clinical trials involving human participants and obtaining authorization from the registering authority, carried out in accordance with paragraphs 63–86 of these Rules). 

Clinical trials for the purpose of state registration of a medical device, for which the confirmation of effectiveness requires clinical trials involving human participants (excluding domestically manufactured medical devices, in vitro diagnostic medical devices, medical devices registered in accordance with special conditions established by the Government of the Russian Federation, and software classified as a medical device), are conducted based on a permit for conducting clinical trials issued by the registering authority, as well as an opinion on the ethical justification of conducting clinical trials issued by the Ethics Council in the field of medical device circulation of the Ministry of Health of the Russian Federation (hereinafter referred to as the Ethics Council), in cases established by these Rules.

Clinical trials involving human participants for the purpose of state registration of a domestically manufactured medical device are conducted based on an opinion on the ethical justification of conducting clinical trials issued by the Ethics Council, in cases established by these Rules. A permit for conducting clinical trials involving human participants, issued by the registering authority, is not required for domestically manufactured medical devices, the state registration procedure for which will be carried out in accordance with paragraphs 101–109 of these Rules.

For in vitro diagnostic medical devices, medical devices registered in accordance with the special conditions established by the Government of the Russian Federation, and software classified as a medical device, obtaining a permit from the registering authority for conducting clinical trials, including those involving human participants, is not required;

d) ensures the conduct of tests for type approval of measuring instruments (for medical devices classified as measuring instruments within the state regulation of ensuring the uniformity of measurements, the list of which is approved by the Ministry of Health of the Russian Federation);

e) the conduct of production inspections of medical devices for compliance with the requirements for implementing, maintaining, and evaluating the quality management system of medical devices depending on the potential risk of their use, as approved by the Government of the Russian Federation (hereinafter referred to as the requirements for implementing, maintaining, and evaluating the quality management system of medical devices). Initial production inspections of medical devices for compliance with the requirements for implementing, maintaining, and evaluating the quality management system of medical devices, conducted to present the results to the registering authority or institution as part of the procedures provided for in Sections II–VI of these Rules, must be conducted by the institution or the expert institution.

32. The Ethics Council is a permanent body established by the Ministry of Health of the Russian Federation for the purpose of conducting evaluations of the ethical justification of clinical trials of medical devices involving human participants as subjects (hereinafter referred to as ethical evaluation).

33. The main tasks of the Ethics Council are:

a) conducting ethical evaluations of documents related to the conduct of clinical trials of medical devices;

b) issuing opinions on the ethical justification of the possibility or impossibility of conducting clinical trials of medical devices involving human participants as subjects. 

34. The Ethics Council, in accordance with its assigned tasks, has the right to:

a) receive documents necessary for conducting ethical evaluations;

b) request missing materials necessary for conducting ethical evaluations from the applicant. 

35. The composition of the Ethics Council is approved by the Ministry of Health of the Russian Federation and consists of representatives of medical and scientific organizations, higher education institutions, public organizations, religious organizations, and the media (hereinafter referred to as Council experts).

The number of representatives from medical organizations must not exceed half of the total number of Council experts.

36. The composition of the Ethics Council is revised as necessary, but no more than once a year.

Changes and additions to the composition of the Ethics Council are approved by an order of the Ministry of Health of the Russian Federation.

37. The Ethics Council includes a chairperson, deputies, and members of the Ethics Council.

38. The chairperson of the Ethics Council is appointed by the Minister of Health of the Russian Federation from among Council experts who hold a higher medical education, an academic degree of Candidate of Medical Sciences or Doctor of Medical Sciences, and have experience in conducting clinical trials of medical devices and addressing ethical issues related to clinical trials of medical devices.

39. The chairperson of the Ethics Council provides overall leadership, determines the directions of the Council's work, organizes its activities, assigns responsibilities among Council experts, and oversees the ethical evaluation process.

In the absence of the chairperson, their duties are performed by one of the deputies with a higher medical education.

40. Council experts must not have any dependency on manufacturers (producers) of medical devices or other parties interested in the results of ethical evaluations.

41. The Ethics Council may establish expert groups.

42. The following requirements apply to Council experts:

a) For individuals with higher medical education:

postgraduate and/or additional professional education, a specialist certificate;

experience in conducting clinical trials of medical devices and addressing ethical issues related to clinical trials of medical devices;

b) For other individuals:

higher education;

experience and knowledge in the field of ethical and legal aspects of protecting the rights and freedoms of individuals and citizens.

43. Meetings of the Ethics Council are conducted by the chairperson or, upon their instruction, by a deputy chairperson and are documented in minutes, which are signed by the chairperson or the deputy chairperson of the Ethics Council.

Materials for an upcoming meeting of the Ethics Council are sent to the Council experts by the department of the Ministry of Health of the Russian Federation responsible for the organizational and technical support of the Ethics Council (hereinafter referred to as the department) no later than three business days before the date of the meeting scheduled by the department.

44. A meeting of the Ethics Council is considered valid if at least two-thirds of its members are present.

Council experts participate in the work of the Council personally; delegation of authority is not permitted.

45. Council experts involved in the planned clinical trial of a medical device are not engaged in the ethical evaluation.

46. Decisions of the Ethics Council are made by open voting by a simple majority of the votes of the Council experts present at the meeting.

In the event of a tie, the decision supported by the presiding chairperson of the meeting is considered adopted.

47. Based on the results of the meeting, the Ethics Council issues an opinion on the ethical justification of conducting the clinical trial of a medical device, in the form specified in the annex. The opinion is signed by the chairperson or the deputy chairperson of the Ethics Council. One copy of the opinion is handed to the applicant or sent by registered mail with acknowledgment of receipt, and the second copy is kept by the department.

48. A Council expert who disagrees with the decision has the right to express their dissenting opinion in writing, which is appended to the relevant opinion of the Ethics Council as specified in paragraph 47 of these Rules and becomes an integral part of it.

49. Information about the composition of the Ethics Council and its work plans is published in the relevant section of the Ministry of Health of the Russian Federation's website on the Internet and is kept up to date.

Information on the current activities of the Ethics Council is published in the relevant section of the Ministry of Health of the Russian Federation's website on the Internet within three business days of the Council meeting.

50. At the applicant's request, the expert institution provides consultations prior to the start of the state registration procedure, including on issues related to the state registration of medical devices, such as preliminary analysis and assessment of the registration dossier, in accordance with the procedure established by the registering authority.

Consultation is not mandatory for obtaining the state service for the registration of medical devices.

To adhere to the principles of independence and impartiality during the evaluation of the quality, effectiveness, and safety of medical devices and to avoid potential conflicts of interest, officials of the expert institution who conducted consultations or inspections of medical device production for compliance with the requirements for implementing, maintaining, and assessing the quality management system cannot perform evaluations of the quality, effectiveness, and safety of the medical device for which they provided consultations.

51. Only one of the applications specified in paragraph 63, paragraph 87, subparagraph "a" of paragraph 101, subparagraph "a" of paragraph 112, subparagraph "a" of paragraph 120, or paragraph 135 of these Rules may be submitted by the applicant in relation to a medical device. If a duplicate and/or new application from those mentioned in the first sentence of this paragraph is submitted or sent to the registering authority or institution during the review of the registration dossier under the procedure specified in these Rules (before the final decision provided for by this procedure is made), such an application will not be accepted by the registering authority or institution.

52. The registering authority forms the registration dossier from the following documents (as applicable):

a) the registration application and documents specified in paragraphs 65, 87, or 101 of these Rules; the application for resuming state registration of a medical device and the documents specified in paragraph 80 of these Rules; requests and documents specified in paragraphs 74 or 96 of these Rules; the application for amendments to the documents contained in the registration dossier and the documents specified in paragraphs 112 and/or 120 of these Rules; as well as the application for the cancellation of state registration of a medical device and the documents specified in subparagraph "b" of paragraph 139 of these Rules;

b) a copy of the task order for conducting an evaluation of the quality, effectiveness, and safety of the medical device, issued by the registering authority;

c) opinions issued by the expert institution during the evaluation of the quality, effectiveness, and safety of the medical device;

d) objections from the applicant to the opinion of the expert institution during the evaluation of the quality, effectiveness, and safety of the medical device and decisions of the registering authority following the review of the applicant's objections to the opinion;

e) copies of orders from the registering authority;

f) copies of notifications sent by the registering authority;

g) copies of inspection reports of the medical device production.

53. Documents contained in the registration dossier are submitted to the registering authority using the applicant's unified personal account in the form of electronic documents or electronic images of documents signed with a qualified or non-qualified electronic signature of the applicant.

Documents in hard copy, for which electronic images are submitted by the applicant, must be certified as required.

54. Documents contained in the registration dossier must be prepared in multicolor format with a resolution of at least 300 dots per inch in *.pdf format with a text layer allowing selection, copying, and searching.

The size of any file in the registration dossier must not exceed 100 MB.

Each document in the registration dossier must include its issue date.

55. If the documents contained in the registration dossier are drawn up in a foreign language, they shall be submitted with a duly certified translation into Russian.

56. The manufacturer's (producer's) technical documentation for the medical device, operational documentation for the medical device, including instructions for use or the user manual, may additionally be submitted via the applicant's unified personal account in the form of information signed with a qualified or non-qualified electronic signature of the applicant.

57. The registering authority is responsible for organizing work on the formation and maintenance of the nomenclature classification of medical devices by type.

58. If the type of a medical device changes during the formation and maintenance of the nomenclature classification of medical devices by type, the registering authority notifies the applicant via the electronic account about the planned change in the type specified in the registry entry.

Within 15 business days from the date the notification mentioned in the first paragraph of this point is posted in the applicant's electronic account, the applicant has the right to review it and, if objections exist, submit them to the registering authority via the electronic account. The applicant may submit such objections only once.

If objections from the applicant are not received within the established term, the registering authority proceeds with amending the registry entry.

If objections regarding the change in the type of medical device are received via the applicant's electronic account within a period not exceeding 15 business days, the registering authority reviews them within 30 business days from the date of receipt, including with the involvement of the expert institution.

If a decision is made to recognize the objections as fully or partially justified, no action is taken to amend the registry entry.

If a decision is made to recognize the objections as fully or partially unjustified, the registering authority notifies the applicant of the decision via the applicant's electronic account (with a reasoned explanation of the decision) and proceeds with amending the corresponding registry entry.

59. The terms and sequence of administrative procedures and actions of the registering authority are established by the administrative regulations for the provision of the state service for the state registration of medical devices, developed in accordance with the requirements established by the Government of the Russian Federation.

60. The following are not permitted in the territory of the Russian Federation:

a) registration of different medical devices under the same name;

b) registration as medical devices of products whose names are listed in the State Register of Medicinal Products for Medical Use, the Unified Register of Registered Medicinal Products of the Eurasian Economic Union, or coincide with the name of a biologically active food supplement included in the Unified Register of Certificates of State Registration of Products. If a medicinal product or a biologically active food supplement is a component of a medical device, their names may be used in the name of the medical device;

c) re-registration by the same manufacturer of the same medical device under a different name.

61. For the purpose of undergoing the state registration procedure, the manufacturer (producer) of the medical device must ensure the compliance of the medical device with the following requirements (as applicable):

a) interchangeability of medical devices must not be restricted through the use of special technical or software means or by other methods unless intended to ensure the safety and effectiveness of the medical device;

b) confirmation of the possibility of joint use of the registered medical device with another medical device from a different manufacturer (producer) registered in accordance with the legislation of the Russian Federation on state registration of medical devices is allowed. Such joint use must take into account the features specified in the operational documentation of the manufacturer (producer) for the registered medical device.

62. Decisions and actions (inaction) of the registering authority that result in a violation of the rights of a legal entity or an individual entrepreneur, as well as conclusions of the expert institution based on evaluations conducted in accordance with these Rules, may be appealed by the applicant in accordance with the legislation of the Russian Federation.

 

II. State Registration of Medical Devices Requiring Clinical Trials Involving Human Participants and Authorization from the Registering Authority for Conducting Clinical Trials

 

63. For the state registration of a medical device, where confirmation of effectiveness requires clinical trials involving human participants and authorization from the registering authority for conducting clinical trials, the applicant submits, via the unified personal account, an application for registration along with the documents specified in paragraph 65 of these Rules.

64. The registration application must include the following information:

a) the name of the medical device (indicating the models (brands) of the medical device, their composition, and accessories necessary for the use of the medical device or its models (brands) as intended, if applicable). The applicant must indicate the trademark and other means of individualization of the medical device if these are applied to the medical device packaging;

b) regarding the manufacturer (producer) of the medical device:

for a legal entity - the full and abbreviated (if available) name (with transliteration), organizational and legal form, taxpayer identification number (for manufacturers who are residents of the Russian Federation), address of the registered office, as well as phone number and email address;

for an individual registered as an individual entrepreneur: the last name, first name, and patronymic (if available), details of the identity document, taxpayer identification number (for manufacturers who are residents of the Russian Federation), address of residence, as well as phone number and email address;

c) regarding the authorized representative of the manufacturer (producer):

for a legal entity: the full and abbreviated (if available) name (with transliteration), organizational and legal form, taxpayer identification number, address of the registered office, as well as phone number and email address;

for an individual registered as an individual entrepreneur: last name, first name, and patronymic (if available); details of the identity document; taxpayer identification number; address of residence; as well as phone number and email address;

d) the name(s) (with transliteration) of the production site(s) and the address(es) of their location;

e) the intended purpose of the medical device as established by the manufacturer (producer) in accordance with the technical and operational documentation for the medical device;

f) the type(s) of the medical device in accordance with the nomenclature classification of medical devices by type, in cases provided for by paragraph 26 of these Rules;

g) the class of potential risk of use of the medical device in accordance with the nomenclature classification of medical devices by risk classes depending on the potential risk of their use, as approved by the Ministry of Health of the Russian Federation;

h) the code of the All-Russian Classifier of Products by Types of Economic Activity (hereinafter referred to as the classifier);

i) information on the possibility (or impossibility) of classifying the medical device as:

software that is a medical device;

software using artificial intelligence technologies that is a medical device;

j) information on the presence (or absence) of direct or indirect contact between the medical device and/or its accessories and the surface of the human body, mucous membranes, or internal body environments, where such interaction (contact) is necessary for the performance of their intended function;

k) information on whether the medical device is classified as a measuring instrument in the field of state regulation of ensuring the uniformity of measurements, the list of which is approved by the Ministry of Health of the Russian Federation;

l) the number, date of the protocol of the technical tests of the medical device, the name of the testing laboratory that issued the protocol, and information on its registration number in the register of accredited entities;

m) the number, date of the protocol of toxicological studies of the medical device and/or its accessories that directly or indirectly contact the surface of the human body, mucous membranes, or internal body environments, where such interaction (contact) is necessary for the performance of their intended function, as well as the name of the testing laboratory that issued the protocol and information on its registration number in the register of accredited entities;

n) the number and date of the protocol of tests conducted on the medical device for the purpose of type approval of measuring instruments (for medical devices classified as measuring instruments in the field of state regulation of ensuring the uniformity of measurements, the list of which is approved by the Ministry of Health of the Russian Federation), as well as the name of the testing laboratory that issued the protocol and information on its registration number in the register of accredited entities;

o) the date and number of the inspection report, its validity period, and the name of the organization that conducted the inspection (specified if the inspection was carried out by an inspection organization under the authority of the registering authority);

p) information on the necessity (or lack thereof) of conducting clinical trials involving human participants;

q) information on the presence (or absence) of a medicinal product, pharmaceutical substance, biological material, or other active substance in the composition of the medical device;

r) information on whether the product is released in a sterile (non-sterile) form;

s) details of the document(s) confirming the right of the manufacturer (producer) to use the trademark and other means of individualization of the medical device if applied to the medical device packaging;

t) information on the payment of the state fee (date and number of the payment order(s));

u) information on the registration number and date of the state registration of the medical device (or amendments made to the documents contained in the registration dossier) (as applicable);

v) information on the possibility (or impossibility) of classifying the medical device as in vitro diagnostic medical devices;

w) information on notifications submitted to the registering authority regarding the import of the medical device for the purpose of its state registration;

x) information on the applicant's responsibility for the accuracy and consistency of the information contained in the registration dossier and the registration application.

65. For the state registration of a medical device, where confirmation of effectiveness requires clinical trials involving human participants and authorization from the registering authority for conducting clinical trials, the following documents must be submitted:

a) a copy (copies) of the document(s) confirming the authority of the authorized representative of the manufacturer (producer) to represent the interests of the manufacturer (producer), bear responsibility regarding the circulation of the medical device in the territory of the Russian Federation, including issues related to conformity assessment and state registration procedures for the medical device, as well as to certify documents of the manufacturer (producer). The document(s) must be valid prior to the preparation of the relevant documents. (The document(s) is mandatory for foreign manufacturers (producers); for domestic manufacturers (producers), the document(s) is submitted if there is an authorized representative of the manufacturer (producer));

b) information on the regulatory documentation for the medical device;

c) technical documentation of the manufacturer (producer) for the medical device;

d) operational documentation of the manufacturer (producer) for the medical device, including instructions for use or the user manual of the medical device;

e) color photographic images of the general view of the medical device, models (brands) of the medical device, and accessories necessary for the use of the medical device as intended (size not less than 18 x 24 centimeters), as well as images of labeling and packaging (color layouts of packaging and labels containing the text of the original labeling and additional labeling in Russian applied to medical devices manufactured outside the Russian Federation);

f) a draft description of the type of measuring instrument that is a medical device (for medical devices classified as measuring instruments in the field of state regulation of ensuring the uniformity of measurements, the list of which is approved by the Ministry of Health of the Russian Federation);

g) a calibration method for the type of measuring instrument that is a medical device (for medical devices classified as measuring instruments in the field of state regulation of ensuring the uniformity of measurements, the list of which is approved by the Ministry of Health of the Russian Federation);

h) a draft plan for clinical trials of the medical device involving human participants with supporting materials (if applicable);

i) documents confirming the ability to conduct production at the address(es) specified in the registration application as the production site(s) (as applicable): documents confirming the availability of production conditions; and/or copies of quality management system certificates of compliance with the requirements of the interstate standard GOST ISO 13485-2017 "Medical Devices. Quality Management Systems. Requirements for Regulatory Purposes," approved and implemented as of June 1, 2018 (hereinafter referred to as GOST ISO 13485-2017), or the corresponding international standard ISO 13485:2016 "Medical Devices. Quality Management Systems. Requirements for Regulatory Purposes" (hereinafter referred to as ISO 13485:2016); copies of reports from previously conducted inspections for compliance with these standards (if such certificates of compliance are provided); and/or copies of documents confirming that the quality management system complies with the requirements for implementing, maintaining, and evaluating the quality management system for medical devices (submitted in cases where inspections were conducted by an inspection organization under the authority of a governmental body of a member state of the Eurasian Economic Union authorized to conduct and/or coordinate activities related to the circulation of medical devices in the territory of that state, excluding the Russian Federation);

j) documents confirming the right of the manufacturer (producer) to use the trademark and other means of individualization of the medical device if applied to the medical device packaging (submitted if the information is not included in the relevant registers of the Federal Service for Intellectual Property);

k) copies of documents confirming the quality of the medicinal product, pharmaceutical substance, biological material, and other substances used in the production of the medical device or included in its composition and intended for use only according to the purpose of the medical device as determined by the manufacturer, issued in accordance with the legislation of the country of origin of the medicinal product, pharmaceutical substance, biological material, and other substances;

l) a copy of the document confirming the registration of the manufacturer (producer) as a legal entity or an individual entrepreneur (except for medical devices whose manufacturers are residents of the Russian Federation);

m) a clinical monitoring plan (for medical devices with a class 3 potential risk of use and for medical devices implantable in the human body with a class 2b potential risk of use);

n) evidence materials of the manufacturer (producer) of the medical device (as applicable):

evidence materials of the manufacturer (producer) of the medical device regarding the determination of the quality and safety of the medical device and its compliance with the requirements of regulatory, technical, and operational documentation of the manufacturer (producer);

evidence materials of the manufacturer (producer) of the medical device regarding research for the evaluation of the biological safety of the medical device.

66. The registering authority is not entitled to require the applicant to include in the registration application any information not provided for in paragraph 64 of these Rules or to submit documents not specified in paragraph 65 of these Rules.

The applicant has the right to submit documents, the information on which is included in the registration application in accordance with subparagraphs "l" - "o," "s" and "w" of paragraph 64 of these Rules, at their discretion.

The applicant has the right to submit other necessary documents at their discretion.

67. Within 5 business days from the date of receipt of the registration application and the documents specified in paragraph 65 of these Rules, the registering authority verifies the completeness and accuracy of the information contained therein, including by comparing such information with data provided by government authorities through interdepartmental information interaction via the interdepartmental electronic interaction system.

68. If the registration application is completed in violation of the provisions of paragraph 64 of these Rules, and/or the submitted documents are completed in violation of the provisions of paragraphs 53–55 of these Rules, and/or the registration application and submitted documents contain inaccurate information, or the documents specified in paragraph 65 of these Rules are incomplete, the registering authority notifies the applicant of the need to address the identified violations and/or provide the missing documents within 30 business days from the date such notification is posted as an electronic document signed with the qualified electronic signature of an authorized official in the applicant's unified personal account and electronic account. The applicant addresses the identified violations and/or provides the missing documents via the applicant's unified personal account.

The time from the day the registering authority notifies the applicant to the day a response to the notification or notification of non-submission of a response to the request is received is not included in the calculation of the term for state registration of the medical device.

69. Within 2 business days from the completion of the verification provided for in paragraph 67 of these Rules (if the registration application is properly completed and all documents specified in paragraph 65 of these Rules are submitted in full), as well as in cases where the identified violations are addressed and/or the documents specified in paragraph 65 of these Rules are submitted within a period not exceeding 30 business days, the registering authority makes a decision to commence state registration of the medical device.

70. If the identified violations are not addressed and/or the missing documents are not submitted within a period not exceeding 30 business days, including considering the provisions of paragraph 53 of these Rules, the registering authority makes a decision to cease further consideration of the registration application and the documents specified in paragraph 65 of these Rules and informs the applicant by posting a corresponding notification, signed with the qualified electronic signature of an authorized official, in the applicant's unified personal account and electronic account, with a reasoned explanation of the reasons for the decision.

71. State registration of medical devices, for which confirmation of effectiveness requires clinical trials involving human participants and authorization from the registering authority for conducting such trials, is carried out by the registering authority within a period not exceeding 50 business days from the date of receipt of the registration application and the documents specified in paragraph 65 of these Rules.

The duration of clinical trials of the medical device involving human participants is not included in this 50-day period.

72. Within 2 business days from the decision to commence state registration of the medical device, the registering authority prepares and issues an assignment for conducting an evaluation of the quality, effectiveness, and safety of the medical device to the expert institution (hereinafter referred to as the assignment for evaluation).

73. The evaluation of the quality, effectiveness, and safety of the medical device, for which confirmation of effectiveness requires clinical trials involving human participants and authorization from the registering authority for conducting such trials, is carried out by the expert institution in stages, in accordance with the procedure approved by the Ministry of Health of the Russian Federation:

a) during Stage I, the registration application and the documents specified in paragraph 65 of these Rules are evaluated to determine the feasibility (or infeasibility) of conducting clinical trials of the medical device involving human participants;

b) during Stage II, the completeness and results of conducted technical tests, toxicological studies, clinical trials, tests for type approval of measuring instruments (for medical devices classified as measuring instruments in the field of state regulation of ensuring the uniformity of measurements, the list of which is approved by the Ministry of Health of the Russian Federation), production inspections, as well as the analysis of evidence materials from the manufacturer (producer) of the medical device (hereinafter referred to as the evaluation of completeness and results of tests and studies) are reviewed.

74. During the evaluation of the quality, effectiveness, and safety of the medical device (at any stage), the expert institution is not permitted to request materials necessary for the evaluation directly from the applicant or any other parties.

If the materials and information contained in the registration application and the documents submitted by the applicant, as specified in paragraph 65 of these Rules, are insufficient for the expert of the expert institution (hereinafter referred to as the expert) to render an opinion, the expert submits a request to the head of the expert institution. The head then addresses the registering authority that issued the assignment for evaluation with a corresponding request. The request must include an exhaustive list of all questions, materials, and information needed by the expert to conduct the evaluation.

The registering authority, within 2 business days from the receipt of the request from the head of the expert institution, sends the applicant a request to provide the necessary materials and information, specifying the nature of the comments and the method of their resolution. This request is sent only once at each stage of the evaluation of the quality, effectiveness, and safety of the medical device in the form of an electronic document signed with the qualified electronic signature of an authorized official, via the applicant's electronic account and unified personal account.

The applicant is required to respond to the registering authority's request via the unified personal account within a period not exceeding 50 business days from the date of the request. Within 2 business days from the receipt of the applicant's response to the request, the registering authority forwards the response to the expert institution. If the applicant fails to respond to the request within 50 business days, the registering authority, within 2 business days, sends a notification to the expert institution regarding the lack of response from the applicant to prepare the expert institution's conclusion based on the documents available to it. 

The time from the date of the registering authority's request to the date of receipt of the applicant's response or the notification of non-submission of a response is not included in the calculation of the evaluation period for the quality, effectiveness, and safety of the medical device.

If the registering authority identifies inaccurate and/or insufficient information and/or non-compliance of the submitted documents with the provisions of paragraphs 53–55 of these Rules in the documents submitted by the applicant in response to the request, the registering authority, within 2 business days, sends (in the form of an electronic document signed with the qualified electronic signature of an authorized official, via the applicant's electronic account and unified personal account) a reasoned decision to the applicant regarding the possibility of resubmitting the revised documents within 50 business days from the date of the request. If the applicant fails to provide the requested materials and information within the specified period, the evaluation of the quality, effectiveness, and safety of the medical device continues based on the documents already available to the expert institution and the information contained in the registration dossier.

75. At Stage I of the evaluation of the quality, effectiveness, and safety of the medical device, the expert institution carries out the following actions within a period not exceeding 17 business days from the receipt of the assignment for evaluation:

a) evaluation of the registration application and the documents specified in paragraph 65 of these Rules to determine the feasibility (or infeasibility) of conducting clinical trials of the medical device involving human participants;

b) preparation and submission to the registering authority of a conclusion regarding the feasibility (or infeasibility) of conducting clinical trials of the medical device involving human participants (indicating the reasons and justification for the infeasibility), in the form approved by the Ministry of Health of the Russian Federation (hereinafter referred to as the conclusion on the clinical trials of the medical device).

76. The grounds for the expert institution issuing a conclusion on the clinical trials of the medical device indicating the infeasibility of conducting clinical trials involving human participants are:

a) non-compliance of the medical device with the requirements of regulatory documentation, technical, and/or operational documentation of the manufacturer (producer);

b) lack of evidence of the safety of the medical device;

c) presence of inaccurate information in the documents contained in the registration dossier.

77. The registering authority, within 5 business days from receiving the conclusion on the clinical trials of the medical device from the expert institution, performs the following actions:

a) evaluation of the conclusion on the clinical trials of the medical device to determine its compliance with the assignment for evaluation. If the conclusion on the clinical trials of the medical device is found to be inconsistent with the assignment, it is returned to the expert institution for revision within a period not exceeding 2 business days from the date the expert institution receives the returned conclusion on the clinical trials of the medical device;

b) in the case of receiving a conclusion on the clinical trials of the medical device as provided in paragraph 76 of these Rules, no later than the next business day after evaluating the conclusion on the clinical trials of the medical device to determine its compliance with the assignment for evaluation, the registering authority places an electronic copy of the conclusion on the clinical trials of the medical device, consistent with the assignment for evaluation, in the applicant's electronic account and provides the relevant information in the applicant's unified personal account.

Within 10 business days from the date of placement in the applicant's electronic account of the conclusion on the clinical trials of the medical device as specified in paragraph 76 of these Rules, the applicant has the right to review the conclusion on the clinical trials of the medical device and, if there are objections, submit their objections to the conclusion via the applicant's electronic account.

If objections to the conclusion on the clinical trials of the medical device provided for in paragraph 76 of these Rules are submitted via the applicant's electronic account within a period not exceeding 10 business days, the registering authority, within 30 business days from the receipt of the objections, reviews them with the involvement of the expert institution that issued the corresponding conclusion on the clinical trials of the medical device. If the objections are not submitted within the specified period, the registering authority carries out the actions provided for in subparagraphs "c" and "d" of this paragraph. When reviewing objections, the registering authority, if necessary, involves the applicant to provide explanations.

Based on the results of the review of objections, a decision is made to either fully or partially recognize the objections as justified. This decision is formalized in a letter from the registering authority and sent to the expert institution, along with the conclusion on the clinical trials of the medical device provided for in paragraph 76 of these Rules, for revision within a period not exceeding 5 business days from the date the expert institution receives the returned conclusion on the clinical trials of the medical device. Alternatively, the objections may be deemed fully unjustified.

The time from the date the registering authority places the conclusion on the clinical trials of the medical device specified in paragraph 76 of these Rules in the applicant's electronic account to the date of the decision following the review of objections is not included in the calculation of the period for evaluating the quality, effectiveness, and safety of the medical device;

c) making a decision on granting authorization for conducting clinical trials of the medical device or refusing state registration of the medical device, formalized by an order of the registering authority, and informing the applicant of the decision by placing a corresponding notification in the form of an electronic document, signed with the qualified electronic signature of an authorized official, in the applicant's unified personal account and electronic account;

d) entering a record in the register of issued authorizations for conducting clinical trials of the medical device, the procedure for maintaining which is approved by the registering authority.

78. When a decision is made to grant authorization for conducting clinical trials of the medical device, the registering authority makes a decision to suspend the state registration procedure for the medical device until the date the registering authority decides to resume the state registration of the medical device in accordance with paragraph 81 of these Rules.

79. The applicant, via their unified personal account, notifies the registering authority about the clinical trials of the medical device involving human participants within 5 business days from the start of the trials.

80. Upon the completion of the clinical trials of the medical device involving human participants, the applicant, via their unified personal account, submits to the registering authority an application for resumption of the state registration of the medical device. The application for registration, prepared in accordance with paragraph 64 of these Rules, should include updated information (if necessary) and information about the results of the clinical trials of the medical device involving human participants (for trials completed before September 1, 2025, the information is submitted as documents), as well as the documents specified in subparagraphs "b"–"g" and "m" of paragraph 65 of these Rules, if they were amended based on the results of the clinical trials of the medical device involving human participants, and updated documents specified in subparagraphs "a," "i," and "l" of paragraph 65 of these Rules (if necessary).

The applicant has the right to submit, at their discretion, documents containing information referenced in the application for registration in accordance with subparagraphs "l"–"o," "s," and "w" of paragraph 64 of these Rules (if amended), as well as documents confirming the results of clinical trials completed after September 1, 2025.

81. he registering authority, within 2 business days from the receipt of the documents specified in paragraph 80 of these Rules, makes a decision to resume the state registration of the medical device.

The decision to resume the state registration of the medical device is made by the registering authority based on the results of a verification of the completeness and accuracy of the information contained in the application for resumption of state registration of the medical device and other documents specified in paragraph 80 of these Rules submitted to the registering authority.

If these documents are incomplete, contain inaccurate information, or fail to comply with the formatting provisions of paragraphs 53–55 of these Rules, the registering authority sends (in the form of an electronic document signed with the qualified electronic signature of an authorized official, via the applicant's unified personal account and electronic account) the applicant a decision to terminate further consideration of the application for resumption of state registration of the medical device, along with a reasoned explanation for the decision. Simultaneously, the registering authority informs the applicant about the possibility of resubmitting the application for resumption of state registration of the medical device with revised documents via the unified personal account.

82. At Stage II of the evaluation of the quality, effectiveness, and safety of the medical device, the registering authority, within 2 business days from the decision to resume the state registration of the medical device, forwards the results of the clinical trials of the medical device involving human participants, along with other documents submitted by the applicant in accordance with paragraph 80 of these Rules, to the expert institution based on the assignment for evaluation issued in accordance with paragraph 72 of these Rules.

83. The expert institution, within a period not exceeding 8 business days from the date of receipt of the documents specified in paragraph 80 of these Rules, conducts an evaluation of the completeness and results of the conducted tests and studies and prepares and submits to the registering authority a conclusion based on the evaluation of the quality, effectiveness, and safety of the medical device, in the form approved by the Ministry of Health of the Russian Federation.

84. The grounds for the expert institution issuing a conclusion based on the evaluation of the quality, effectiveness, and safety of the medical device, indicating the impossibility of state registration of the medical device, are as follows:

a) non-compliance of the medical device with the requirements of regulatory documentation, technical, and/or operational documentation of the manufacturer (producer);

b) lack of evidence of the quality, and/or effectiveness, and/or safety of the medical device;

c) determination that the risk of harm to the health of citizens and medical workers from using the medical device outweighs the effectiveness of its use;

d) submission of inaccurate information in the documents contained in the registration dossier.

85. Within a period not exceeding 7 business days from the date of receipt of the conclusion based on the evaluation of the quality, effectiveness, and safety of the medical device, the registering authority carries out the following actions:

a) evaluation of the conclusion based on the results of the evaluation of the quality, effectiveness, and safety of the medical device, as specified in paragraph 83 of these Rules, to determine its compliance with the assignment for evaluation. If the conclusion based on the results of the evaluation of the quality, effectiveness, and safety of the medical device does not comply with the assignment, the conclusion is returned to the expert institution for revision within a period not exceeding 2 business days from the date the expert institution receives the returned conclusion based on the results of the evaluation of the quality, effectiveness, and safety of the medical device;

b) in the case of receiving a conclusion based on the evaluation of the quality, effectiveness, and safety of the medical device, as provided in paragraph 84 of these Rules, no later than the next business day after evaluating such a conclusion to determine its compliance with the assignment for evaluation, the registering authority places an electronic copy of the conclusion based on the evaluation of the quality, effectiveness, and safety of the medical device, consistent with the assignment for evaluation, in the applicant's electronic account and provides the relevant information in the applicant's unified personal account.

Within 10 business days from the placement of the conclusion based on the evaluation of the quality, effectiveness, and safety of the medical device, as specified in paragraph 84 of these Rules, in the applicant's electronic account, the applicant has the right to review the conclusion and, if there are objections, submit them via their electronic account.

If objections to the conclusion specified in paragraph 84 of these Rules are submitted via the applicant's electronic account within a period not exceeding 10 business days, the registering authority reviews them within 30 business days from the date of receipt, involving the expert institution that issued the conclusion. If objections are not submitted within the specified period, the registering authority performs the actions specified in subparagraphs "c" and "d" of this paragraph. When reviewing objections, the registering authority may involve the applicant if explanations are required.

Based on the results of the review, a decision is made either to fully or partially recognize the objections as justified, formalized in a letter from the registering authority, and sent to the expert institution along with the conclusion specified in paragraph 84 of these Rules, which requires revision within a period not exceeding 5 business days from the date the expert institution receives the returned conclusion, or to recognize the objections as fully unjustified.

The time from the date the registering authority places the conclusion based on the evaluation of the quality, effectiveness, and safety of the medical device, as specified in paragraph 84 of these Rules, in the applicant's electronic account, until the decision on the objections is made, is not included in the calculation of the period for evaluating the quality, effectiveness, and safety of the medical device;

c) making a decision on the state registration of the medical device or on the refusal of state registration, formalized by an order of the registering authority, and informing the applicant of the decision by placing a corresponding notification in the form of an electronic document, signed with the qualified electronic signature of an authorized official, in the applicant's unified personal account and electronic account;

d) making an entry in the state register of registration record.

86. The grounds for the registering authority to refuse state registration of a medical device are:

a) receiving from the expert institution a conclusion on the clinical trials of the medical device indicating the impossibility of conducting clinical trials involving human participants;

b) receiving from the expert institution a conclusion based on the evaluation of the quality, effectiveness, and safety of the medical device, indicating the impossibility of state registration of the medical device, and/or the registering authority's decision to recognize the applicant's objections as fully or partially unjustified;

c) identifying, during federal state control (supervision) over the circulation of medical devices, inconsistencies between the data on the effectiveness and safety of the medical device and the information contained in the application for registration and the documents specified in paragraphs 65 and 80 of these Rules.

 

III. State registration of medical devices, the confirmation of the effectiveness of which does not require clinical trials involving human participants or obtaining authorization from the registering authority to conduct such clinical trials

 

87. For the state registration of a medical device, the confirmation of the effectiveness of which does not require clinical trials involving human participants or obtaining authorization from the registering authority to conduct such clinical trials, the applicant, via their unified personal account, submits to the registering authority a registration application prepared in accordance with paragraph 64 of these Rules and additionally containing information on the presence (or absence) of an embedded function in software utilizing artificial intelligence technologies, which is a medical device, for the automatic transfer, in the manner approved by the registering authority, of information on processed data, the results of the software's actions, and the data specified by the procedure for reporting by entities engaged in the circulation of medical devices regarding all cases of adverse effects not indicated in the instructions for use or the operating manual, undesirable reactions during use, specific features of interactions between medical devices, and facts or circumstances that pose a threat to the life and health of citizens and medical workers during the use and operation of medical devices, as approved by the Ministry of Health of the Russian Federation (hereinafter referred to as the procedure for reporting by entities engaged in the circulation of medical devices regarding all cases of adverse effects); as well as information on the results of clinical trials of the medical device (without human participation), including the number and date of the report on the evaluation of the clinical trial results and the name of the medical organization; and the following documents:

a) a copy (copies) of the document(s) confirming the authority of the authorized representative of the manufacturer (producer) to represent the manufacturer's (producer's) interests, assume responsibility for the circulation of the medical device in the Russian Federation, including issues related to conformity assessment and state registration procedures for the medical device, as well as to certify the manufacturer’s (producer’s) document(s) issued before the corresponding documents were prepared (the document(s) is (are) mandatory for foreign manufacturers (producers) and is (are) submitted by domestic manufacturers (producers) if an authorized representative of the manufacturer (producer) is available);

b) information on regulatory documentation for the medical device;

c) technical documentation of the manufacturer (producer) for the medical device;

d) operational documentation of the manufacturer (producer) for the medical device, including instructions for use or the user manual for the medical device;

e) color photographic images of the general view of the medical device, its models (brands), and accessories necessary for the intended use of the medical device (size no less than 18 x 24 centimeters), as well as images of labeling and packaging (color mockups of packaging and labels containing the text of the original labeling and additional labeling in Russian, applied to medical devices manufactured outside the Russian Federation) (except for software that is a medical device);

f) color photographic images of the electronic medium and software interface (size no less than 18 x 24 centimeters) (for software that is a medical device), as well as images of labeling and packaging (if available);

g) draft description of the type of measuring instrument that is a medical device (for medical devices classified as measuring instruments within the scope of state regulation ensuring measurement uniformity, the list of which is approved by the Ministry of Health of the Russian Federation);

h) verification methodology for the type of measuring instrument that is a medical device (for medical devices classified as measuring instruments within the scope of state regulation ensuring measurement uniformity, the list of which is approved by the Ministry of Health of the Russian Federation);

i) documents confirming the results of clinical trials of medical devices (as applicable, depending on the date):

documents confirming the results of clinical trials (for clinical trials completed before September 1, 2025);

documents confirming the results of clinical trials (for clinical trials completed after September 1, 2025) (at the applicant's discretion).

j) documents confirming the capability to carry out production at the address(es) specified in the registration application as the production site(s) (if applicable): documents confirming the availability of production conditions, and/or copies of certificates of compliance with the quality management system requirements of GOST ISO 13485-2017 or ISO 13485:2016, as well as copies of reports on previous inspections for compliance with these standards (if such certificates of compliance are provided), and/or copies of documents confirming the quality management system's compliance with the requirements for the implementation, maintenance, and evaluation of the quality management system of medical devices (submitted if the inspection is conducted by an inspecting organization subordinate to the government authority of a Eurasian Economic Union member state responsible for or coordinating activities related to the circulation of medical devices within that state, excluding the Russian Federation);

k) documents confirming the manufacturer's (producer's) right to use trademarks and other means of individualization of the medical device if applied to the packaging of the medical device (submitted if the information is not included in the relevant registers of the Federal Service for Intellectual Property);

l) copies of documents confirming the quality of pharmaceutical drugs, pharmaceutical substances, biological materials, and other substances used in the manufacturing of the medical device or included in its composition, which are intended for use only as specified by the medical device’s designated purpose, as determined by the manufacturer, and issued in accordance with the legislation of the country of origin of the pharmaceutical drug, pharmaceutical substance, biological material, and other substances (excluding medical devices for in vitro diagnostics);

m) a copy of the document confirming the manufacturer’s (producer's) registration as a legal entity or individual entrepreneur (except for medical devices manufactured by residents of the Russian Federation);

n) a clinical monitoring plan (for medical devices classified under risk class 3, as well as for implantable medical devices classified under risk class 2b);

o) substantiating materials from the manufacturer (producer) of the medical device (if applicable):

substantiating materials from the manufacturer (producer) regarding the determination of the medical device's quality and safety, and its compliance with the requirements of regulatory, technical, and operational documentation of the manufacturer (producer);

substantiating materials from the manufacturer (producer) regarding studies conducted to assess the biological safety of the medical device.

88. The registering authority shall not require the applicant to specify information in the application for registration that is not provided for in paragraph 64 of these Rules or to submit documents that are not stipulated in paragraph 87 of these Rules.

The applicant has the right to submit, at their discretion, documents containing information referenced in the application for registration in accordance with subparagraphs "l"–"o", "s" and "w" of paragraph 64 of these Rules.

The applicant also has the right to submit any other necessary documents at their discretion.

89. Within 5 business days from the date of receipt of the application for registration and the documents specified in paragraph 87 of these Rules, the registering authority shall verify the completeness and accuracy of the information contained therein, including by comparing such information with data provided by government authorities through interagency information interaction via the interagency electronic interaction system.

90. If the application for registration is submitted in violation of the provisions of paragraph 64 of these Rules and/or the submitted documents are prepared in violation of the provisions of paragraphs 53–55 of these Rules, and/or the application for registration and the submitted documents contain inaccurate information, or the documents specified in paragraph 87 of these Rules are incomplete, the registering authority shall notify the applicant of the need to address the identified violations and/or submit missing documents within 30 business days from the date of such notification. The notification shall be provided in the form of an electronic document, signed with an enhanced qualified electronic signature of an authorized official, and placed in the applicant's unified personal account and electronic account. The applicant shall address the identified violations and/or submit the missing documents through the unified personal account.

The time between the notification by the registering authority and the receipt of the applicant's response to the notification or a notice of non-submission of the response shall not be counted when calculating the term for the state registration of the medical device.

91. Within 3 business days from the completion of the verification specified in paragraph 89 of these Rules (in the case of a properly prepared application for registration and complete documents as specified in paragraph 87 of these Rules), as well as in the case of addressing the identified violations and/or submitting the documents specified in paragraph 87 of these Rules within 30 business days, the registering authority shall decide to initiate the state registration of the medical device.

92. If the identified violations are not addressed and/or the missing documents are not submitted within 30 business days, including taking into account the provisions of paragraph 53 of these Rules, the registering authority shall decide to terminate further consideration of the application for registration and the documents specified in paragraph 87 of these Rules. The applicant shall be informed of this decision by placing the corresponding notification with a reasoned justification in the form of an electronic document, signed with an enhanced qualified electronic signature of an authorized official, in the applicant's unified personal account and electronic account.

93. State registration of medical devices, for which confirmation of effectiveness does not require clinical trials involving humans or obtaining permission from the registering authority to conduct such clinical trials, shall be carried out by the registering authority within a period not exceeding 31 business days from the date of receipt of the application for registration and the documents specified in paragraph 87 of these Rules.

94. Within 3 business days from the decision to initiate the state registration of a medical device, the registering authority shall prepare and issue an assignment for examination to the expert institution.

95. For medical devices for which confirmation of effectiveness does not require clinical trials involving humans or obtaining permission from the registering authority to conduct such clinical trials, the examination of the application for registration and the documents specified in paragraph 87 of these Rules shall be conducted simultaneously with the examination of the completeness and results of tests and studies within a period not exceeding 10 business days from the date the expert institution receives the corresponding assignment from the registering authority.

96. During the examination of the quality, effectiveness, and safety of the medical device, the expert institution shall not request materials necessary for the examination from the applicant or other persons.

If the materials and information provided by the applicant in the application for registration and the documents specified in paragraph 87 of these Rules are insufficient for the expert to reach a conclusion, the expert shall raise the issue of obtaining the necessary materials and information with the head of the expert institution, who shall submit an appropriate request to the registering authority that issued the assignment for the examination. This request shall include a comprehensive list of all questions, materials, and information required by the expert to conduct the examination.

The registering authority, within 2 business days from the receipt of the request from the head of the expert institution, shall send the applicant a request for the provision of the necessary information, specifying the nature of the remarks and the method for their resolution. This request shall be sent only once and provided to the applicant in the form of an electronic document signed with the enhanced qualified electronic signature of an authorized official, by placing it in the applicant's electronic account and unified personal account.

The applicant is required to provide a response to the registering authority's request via the applicant's unified personal account within 50 business days from the date the request was sent. Within 2 business days from the receipt of the applicant's response to the request, the registering authority forwards this response to the expert institution. In the event that the applicant fails to provide a response within 50 business days, the registering authority, within 2 business days, sends a notification to the expert institution regarding the applicant's failure to respond to the registering authority's request. This notification enables the expert institution to prepare a conclusion based on the available documents regarding the quality, effectiveness, and safety of the medical device.

The time from the date the registering authority sends the request to the date the response or notification of failure to respond is received is not included in the calculation of the term for the examination of the quality, effectiveness, and safety of the medical device.

If the registering authority detects inaccurate and/or insufficient information or documents, or inconsistencies in the formatting of the documents provided by the applicant in response to the request as outlined in paragraphs 53–55 of these Rules, the registering authority, within 2 business days, sends (in the form of an electronic document signed with the enhanced qualified electronic signature of an authorized official via the applicant's unified personal account and electronic account) the applicant a reasoned decision allowing for the re-submission of revised documents within 50 business days from the date the request was sent. If the applicant fails to provide the requested materials and information within this timeframe, the examination of the quality, effectiveness, and safety of the medical device continues based on the documents and information previously submitted by the applicant and available in the registration dossier.

97. The expert institution conducts an examination of the quality, effectiveness, and safety of the medical device within a period not exceeding 10 business days from the receipt of the documents specified in paragraph 87 of these Rules and submits the conclusion of the examination to the registering authority.

98. The grounds for the expert institution to issue a conclusion based on the results of the examination of the quality, effectiveness, and safety of the medical device, indicating the impossibility of state registration of the medical device, include:

a) non-compliance of the medical device with the requirements of regulatory documentation, technical and/or operational documentation of the manufacturer;

b) lack of evidence of the quality, and/or effectiveness, and/or safety of the medical device;

c) determination that the risk of harm to the health of citizens and healthcare workers due to the use of the medical device outweighs its effectiveness;

d) presence of inaccurate information in the documents contained in the registration dossier.

99. Within a period not exceeding 10 business days from the receipt of the conclusion on the results of the examination of the quality, effectiveness, and safety of the medical device, the registering authority carries out the following activities:

a) evaluation of the conclusion on the results of the examination of the quality, effectiveness, and safety of the medical device, specified in paragraph 97 of these Rules, to determine compliance with the assignment for the examination. If it is determined that the conclusion on the results of the examination of the quality, effectiveness, and safety of the medical device does not comply with the assignment, such a conclusion is returned to the expert institution for revision, which must be completed within 2 business days from the date the expert institution receives the returned conclusion;

b) if the conclusion on the results of the examination of the quality, effectiveness, and safety of the medical device, specified in paragraph 98 of these Rules, is received, no later than the next business day after conducting the evaluation of such a conclusion for compliance with the assignment, the registering authority places an electronic copy of the conclusion, which complies with the assignment, in the applicant's electronic account and sends the relevant information to the applicant's unified personal account.

Within 10 business days from the date the conclusion on the results of the examination of the quality, effectiveness, and safety of the medical device, specified in paragraph 98 of these Rules, is placed in the applicant's electronic account, the applicant has the right to review the conclusion and, if there are objections, submit their objections via the applicant's electronic account.

If the applicant submits objections to the conclusion on the results of the examination of the quality, effectiveness, and safety of the medical device, specified in paragraph 98 of these Rules, via the electronic account within a period not exceeding 10 business days, the registering authority considers these objections within 30 business days from the date of receipt, involving the expert institution that issued the conclusion. If objections are not received within the specified period, the registering authority undertakes the activities specified in subparagraphs "c" and "d" of this paragraph. If necessary, the registering authority involves the applicant to provide explanations during the consideration of objections.

Based on the results of the consideration of objections, the registering authority makes a decision to recognize the objections as fully or partially justified, which is formalized by a letter from the registering authority and sent to the expert institution along with the conclusion on the results of the examination of the quality, effectiveness, and safety of the medical device, specified in paragraph 98 of these Rules, for revision. The revision period shall not exceed 5 business days from the date the expert institution receives the returned conclusion on the results of the examination of the quality, effectiveness, and safety of the medical device. Alternatively, the registering authority may make a decision to recognize the objections as fully unjustified.

The time from the placement of the conclusion on the results of the examination of the quality, effectiveness, and safety of the medical device by the registering authority in the applicant’s electronic account, as specified in paragraph 98 of these Rules, to the adoption of a decision on the results of the consideration of objections is not included in the calculation of the duration of the examination of the quality, effectiveness, and safety of the medical device;

c) adoption of a decision on state registration of the medical device or refusal of state registration, which is formalized by an order of the registering authority, and informing the applicant about the decision by placing the corresponding notification in the form of an electronic document signed by the qualified electronic signature of an authorized official in the applicant’s unified personal account and electronic account;

d) entry of the registry record into the state register.

100. The grounds for the registering authority's decision to refuse state registration of a medical device are:

a) receiving from the expert institution a conclusion on the results of the examination of the quality, effectiveness, and safety of the medical device, indicating the impossibility of state registration of the medical device and/or the adoption by the registering authority of a decision recognizing the applicant’s objections as partially or completely unfounded;

b) detection by the registering authority, based on the results of federal state control (supervision) over the circulation of medical devices, of discrepancies between the data on the effectiveness and safety of the medical device and the data contained in the registration application and the documents specified in paragraph 87 of these Rules.

 

IV. Features of the State Registration of Domestic Medical Devices

 

101. For the state registration of domestic medical devices, the applicant submits or sends to the institution, in hard copy, the following documents and information:

a) an application for the examination of the quality, effectiveness, and safety of the medical device containing information in accordance with paragraph 64 of these Rules (excluding subparagraphs "l"–"o," "s" and "w") and information about the presence of a built-in function in software utilizing artificial intelligence technologies, which constitutes a medical device, for automatic transmission, as established by the registering authority, to the automated information system of the registering authority. This includes data on the processed information, the results of the software operation utilizing artificial intelligence technologies as a medical device, as well as information provided under the procedure for reporting by entities involved in the circulation of medical devices on all cases of adverse effects;

b) a copy (copies) of the document(s) confirming the authority of the authorized representative of the manufacturer (producer) to represent the interests of the manufacturer (producer), to bear responsibility for the circulation of the medical device within the territory of the Russian Federation, including issues related to conformity assessment procedures and state registration of the medical device;

c) information on the regulatory documentation for the medical device;

d) technical documentation of the manufacturer (producer) for the medical device;

e) operational documentation of the manufacturer (producer) for the medical device, including instructions for use or an operation manual for the medical device;

f) color photographic images of the general view of the medical device, models (brands) of the medical device, and accessories required for using the medical device as intended (size not less than 18 x 24 centimeters), as well as images of labeling and packaging (color layouts of packages and labels containing the text of the original labeling and additional labeling in Russian applied to medical devices manufactured outside the Russian Federation) (excluding software that is a medical device);

g) color photographic images of the electronic carrier and interface of the software (size not less than 18 x 24 centimeters) (for software that is a medical device), as well as images of labeling and packaging (if available);

h) information on documents confirming the results of technical tests of the medical device issued by the institution, and supporting materials of the manufacturer (producer) of the medical device (if available);

i) information on documents confirming the results of toxicological studies of the medical device and (or) accessories to the medical device that directly or indirectly contact the surface of the human body, its mucous membranes, or internal body environments, for which such interaction (contact) is necessary to perform their intended functions, issued by the institution, and supporting materials of the manufacturer (producer) of the medical device (if available);

j) information on documents confirming the results of tests of the medical device to approve the type of measuring instruments (for medical devices classified as measuring instruments within the scope of state regulation to ensure the uniformity of measurements, the list of which is approved by the Ministry of Health of the Russian Federation), issued by the institution;

k) documents confirming the results of clinical trials of medical devices issued by medical organizations that meet the requirements approved by the Ministry of Health of the Russian Federation and are included in the network of national medical research centers, the composition of which is approved by the Ministry of Health of the Russian Federation, and software using artificial intelligence technologies designed to process medical images obtained during radiological examinations, including computed tomography, radiography, fluorography, and mammography, provided that clinical trials were conducted at the clinical center (for clinical trials completed before September 1, 2025), or information on the results of clinical trials of the medical device indicating the number and date of the act of clinical trials of the medical device, as well as the name of the medical organization (for clinical trials completed after September 1, 2025).

l) documents confirming the possibility of carrying out production at the address(es) specified in the registration application as the production site(s) (if applicable): documents confirming the availability of production conditions, and (or) copies of certificates of compliance of the quality management system with the requirements of GOST ISO 13485-2017 or ISO 13485:2016, as well as copies of reports of previously conducted inspections for compliance with these standards (if the specified certificates of compliance are provided), and (or) copies of documents confirming compliance of the quality management system with the requirements for implementing, maintaining, and evaluating the quality management system of medical devices;

m) documents confirming the manufacturer's (producer's) right to use the trademark and other means of individualization of the medical device if applied to the packaging of the medical device;

n) copies of documents confirming the quality of the medicinal product, pharmaceutical substance, biological material, or other substances used to manufacture the medical device or included in its composition, intended only for the purposes defined by the manufacturer, issued in accordance with the legislation of the country of origin of the medicinal product, pharmaceutical substance, biological material, or other substances (excluding medical devices for in vitro diagnostics);

o) an inventory of documents required to be submitted under this paragraph, indicating the section IV of these Rules under which the procedure for state registration of the domestic medical device is planned;

p) a clinical monitoring plan (for medical devices of class 3 potential risk and medical devices implanted into the human body of class 2b potential risk);

102. The requirements specified in paragraphs 53, 54, and 56 of these Rules regarding the documents to be submitted under paragraph 101 of these Rules do not apply.

103. The institution, within 25 business days from the date of receipt of the documents specified in paragraph 101 of these Rules:

a) conducts an examination of the application for an assessment of the quality, effectiveness, and safety of the medical device and the documents specified in paragraph 101 of these Rules, including an assessment of the completeness of the documents and the reliability of the information contained therein, concurrently conducting an evaluation of the completeness and results of tests and studies;

b) prepares a conclusion on the results of the assessment of the quality, effectiveness, and safety of the medical device;

c) if the conclusion on the results of the assessment of the quality, effectiveness, and safety of the medical device, specified in subparagraph "b" of this paragraph, is positive, the institution submits this conclusion to the registering authority.

Documents submitted by the applicant under paragraphs 101 and 104 of these Rules are attached to the conclusion on the results of the assessment of the quality, effectiveness, and safety of the medical device, indicating the possibility of state registration of the domestic medical device;

d) if the conclusion on the results of the assessment of the quality, effectiveness, and safety of the medical device is negative, the institution notifies the applicant of the results of the conducted assessment of the quality, effectiveness, and safety of the medical device (by registered mail with acknowledgment of receipt or in the form of an electronic document signed with an enhanced qualified electronic signature of an authorized official, sent to the applicant's email address specified in the application for the assessment of the quality, effectiveness, and safety of the medical device), attaching the conclusion on the results of the assessment of the quality, effectiveness, and safety of the medical device, indicating the impossibility of state registration of the domestic medical device.

104. If the materials and information contained in the documents submitted by the applicant as stipulated in paragraph 101 of these Rules are insufficient for the institution to issue a conclusion on the results of the examination of the quality, efficacy, and safety of the medical device as specified in subparagraph "b" of paragraph 103 of these Rules, the institution shall, within 15 business days from the date of receipt of the documents, send the applicant a request for the provision of the necessary information. This request is sent by registered mail with acknowledgment of receipt or as an electronic document signed with a qualified electronic signature of an authorized official to the applicant's email address specified in the application for the examination of the quality, efficacy, and safety of the medical device. The request must specify the nature of the remarks and how to address them.

This request is sent only once and must contain a comprehensive list of all questions and materials required for the expert to conduct the examination.

The applicant is required to respond to the institution's request within 35 business days from the date the request is sent. The institution shall prepare a conclusion on the results of the examination of the quality, efficacy, and safety of the medical device within 10 business days from the date of receipt of the applicant's response to the request.

If the applicant fails to provide a response to the request within 35 business days, the institution shall prepare a conclusion on the results of the examination of the quality, efficacy, and safety of the medical device based on the documents available to it.

The period from the date the institution sends the request to the date the response to the request is received shall not be included in the calculation of the time required for the examination of the quality, efficacy, and safety of the medical device.

105. A conclusion on the results of the examination of the quality, efficacy, and safety of the medical device, indicating the impossibility of state registration of the domestic medical device, shall be prepared by the institution if the following grounds exist:

a) non-compliance of the medical device with the requirements of regulatory documentation, technical documentation, and/or operational documentation of the manufacturer (producer);

b) lack of evidence of the quality, and/or efficacy, and/or safety of the medical device;

c) determination that the risk of harm to the health of citizens and healthcare workers as a result of the use of the medical device exceeds its effectiveness;

d) the documents specified in paragraph 101 of these Rules are not submitted in full, including under paragraph 104 of these Rules, and/or contain inaccurate information, and/or do not comply with the requirements of paragraph 55 of these Rules.

106. Within 5 business days from the date of receipt of the conclusion on the results of the examination of the quality, efficacy, and safety of the medical device as specified in subparagraph "c" of paragraph 103 of these Rules, the registering authority shall evaluate the conclusion and decide either to return the conclusion to the institution for revision, which shall be completed within 2 business days from the date the institution receives the returned conclusion, or to accept the conclusion on the results of the examination of the quality, efficacy, and safety of the medical device.

107. The institution, within 2 business days from the date of receiving the notification of acceptance of the conclusion on the results of the examination of the quality, efficacy, and safety of the medical device, shall notify the applicant (by registered mail with acknowledgment of receipt or as an electronic document signed with a qualified electronic signature of an authorized official, sent to the applicant's email address specified in the application provided under subparagraph "a" of paragraph 101 of these Rules) of the need to submit, via the applicant's unified personal account, to the registering authority, in accordance with the requirements of paragraph 53 of these Rules, an application for the registration of the domestic medical device. The application must be prepared in accordance with paragraph 64 of these Rules and additionally include the details of the conclusion on the results of the examination of the quality, efficacy, and safety of the domestic medical device issued by the institution. The application for the registration of the domestic medical device must be submitted within 30 business days from the date the institution sends the notification provided in this paragraph.

108. Within 5 business days from the date of receipt of the application for the registration of the domestic medical device, the registering authority shall verify the completeness and accuracy of the information contained therein, including by comparing such information with data provided by government authorities in the framework of interdepartmental information interaction through the interdepartmental electronic interaction system.

109. Within 5 business days from the date of completion of the verification specified in paragraph 108 of these Rules:

a) if the application for the registration of the domestic medical device is duly completed, the registering authority shall decide on the state registration of the medical device. This decision is formalized by an order of the registering authority, and the applicant is informed of the decision by placing a corresponding notification in the form of an electronic document signed with a qualified electronic signature of an authorized official in the applicant's unified personal account and personal account. The registering authority shall also make an entry in the state register;

b) if the application for the registration of the domestic medical device contains inaccurate information or if the information specified in paragraph 64 of these Rules is incomplete, the registering authority shall decide to cease further consideration of the application for the registration of the domestic medical device and shall inform the applicant by placing a corresponding notification with a reasoned justification for the decision in the form of an electronic document signed with a qualified electronic signature of an authorized official in the applicant's unified personal account and personal account.

 

V. Making Amendments to the Documents Contained in the Registration Dossier That Do Not Require an Examination of the Quality, Efficacy, and Safety of the Medical Device

 

110. Changes to the documents contained in the registration dossier that require the state registration of a new medical device include:

a) changes resulting in alterations to the functional purpose and/or principle of operation of the medical device;

b) inclusion of information on models (brands) of the registered medical device that do not meet the criteria specified in paragraph 26 of these Rules;

c) changes leading to simultaneous modifications of the information about the manufacturer and the production site(s) relative to the information specified in the registry entry, except for changes in the legal form, address of location, reorganization, or other details contained in the constituent documents.

111. Changes made to the documents contained in the registration dossier that do not require an examination of the quality, efficacy, and safety of the medical device include:

a) updates to the validity periods of documents contained in the registration dossier (updating of documents in the registration dossier by the applicant);

b) changes made by the manufacturer of medical devices of potential risk class 1 or non-sterile medical devices of potential risk class 2a, which have undergone quality management system evaluations, including processes for the design and development of medical devices, in accordance with the requirements for the implementation, maintenance, and evaluation of the quality management system for medical devices (excluding changes requiring the state registration of a new medical device in accordance with paragraph 110 of these Rules).

In cases where the validity period of the inspection report for the production of medical devices of potential risk class 1 or non-sterile medical devices of potential risk class 2a has expired, the application for changes to the documents contained in the registration dossier is considered based on the grounds specified in subparagraphs "a," "c"–"f" of this paragraph and paragraph 119 of these Rules;

c) changes in the information about the manufacturer of the medical device, including details regarding:

reorganization of a legal entity;

changes to the names of the legal entity (full and abbreviated, including trade names), or address of its location;

changes to the last name, first name, and patronymic (if applicable), address of residence of an individual registered as an individual entrepreneur, and the details of the document confirming their identity;

changes to the address(es) of the production site(s) if the change is due to the renaming of a geographical object, street, square, or other area, or changes to the numbering of address objects, including postal codes;

d) changes in the information about the authorized representative of the manufacturer, including details regarding:

reorganization of a legal entity;

changes to the name of the legal entity (full and abbreviated, including trade names, if applicable) or the address of its location;

changes to the last name, first name, and patronymic (if applicable), address of residence of an individual registered as an individual entrepreneur, and the details of the document confirming their identity;

e) changes to the name of the medical device concerning the trademark and other means of individualization;

f) exclusion of information about a model (brand) of the medical device from the registry entry;

g) changes to the design of the marking without altering the symbols used for marking the medical device;

h) changes to the classifier code in the event of a new edition of the classifier being issued after the decision on state registration of the medical device or changes to the documents contained in the registration dossier.

112. To amend the documents contained in the registration dossier as specified in paragraph 111 of these Rules, the applicant shall, no later than 90 business days from the date of the corresponding changes, submit the following to the registering authority via the applicant's unified account:

a) an application to amend the documents contained in the registration dossier, which do not require an examination of the quality, effectiveness, and safety of the medical device. The application must include the information specified in paragraph 64 of these Rules and additional information on the proposed changes, as well as (if applicable) information on the results of clinical trials of the medical device, specifying the number and date of the act of assessment of the clinical trial results and the name of the medical organization;

b) a copy (copies) of the document(s) confirming the authority of the authorized representative of the manufacturer (producer) to represent the interests of the manufacturer (producer), to bear responsibility for the circulation of the medical device within the Russian Federation, including matters related to conformity assessment procedures and state registration of the medical device, as well as to certify the document(s) of the manufacturer (producer) that took effect before the relevant documents were formalized. This document (these documents) is (are) mandatory for foreign manufacturers (producers) and may be submitted by domestic manufacturers (producers) if they have an authorized representative;

c) the documents specified in paragraph 65 of these Rules, which have been amended, and evidence showing that these changes do not affect the properties and characteristics of the medical device that influence its safety, quality, and effectiveness, or improve its properties and characteristics without altering the functional purpose and/or operating principle of the medical device;

d) copies of reports on the results of production inspections (in the case specified in subparagraph "b" of paragraph 111 of these Rules):

copies of documents confirming compliance of the quality management system with the requirements for implementing, maintaining, and evaluating the quality management system for medical devices (if the inspection was conducted by an inspection organization under the authority of the registering body) (submitted at the applicant's discretion);

copies of documents confirming compliance of the quality management system with the requirements for implementing, maintaining, and evaluating the quality management system for medical devices (submitted if the inspection was conducted by an inspection organization under the authority of a state body of a member state of the Eurasian Economic Union, authorized to perform and/or coordinate activities related to the circulation of medical devices in that state, excluding the Russian Federation).

113. The registering authority is not entitled to require the applicant to include information or submit documents in the application for amending the documents contained in the registration dossier that do not require an examination of the quality, effectiveness, and safety of the medical device, beyond those specified in paragraph 112 of these Rules.

The applicant may, at their discretion, submit other documents justifying the amendments that do not result in changes to the properties and characteristics of the medical device affecting its safety, quality, and effectiveness, or that improve its properties and characteristics without altering the functional purpose and/or operating principle of the medical device.

The procedure for amending the documents contained in the registration dossier that do not require an examination of the quality, effectiveness, and safety of the medical device shall be carried out by the registering authority within a period not exceeding 18 business days from the date of receipt of the application for amending the documents contained in the registration dossier and the documents specified in paragraph 112 of these Rules.

114. Within 5 business days from the date of receipt of the application for amending the documents contained in the registration dossier that do not require an examination of the quality, effectiveness, and safety of the medical device, and the documents specified in paragraph 112 of these Rules, the registering authority shall verify the completeness and accuracy of the information contained therein, including by comparing such information with data provided by state authorities through interagency electronic interaction systems.

115. If the application for amending the documents contained in the registration dossier that do not require an examination of the quality, effectiveness, and safety of the medical device is submitted in violation of paragraph 64 and subparagraph "a" of paragraph 112 of these Rules, and/or the submitted documents are formatted in violation of paragraphs 53–55 of these Rules, and/or the application and submitted documents contain inaccurate information, and/or the documents specified in paragraph 112 of these Rules are incomplete, the registering authority shall notify the applicant of the need to correct the identified violations and/or provide missing documents within 30 business days from the date of posting such notification in the form of an electronic document signed with a qualified electronic signature of an authorized official, in the applicant's unified account and electronic account. The applicant shall address the identified violations and/or provide missing documents through the unified account.

The time from the date the registering authority notifies the applicant to the date of receipt of the response to the notification or the notification of non-response is not included in the calculation of the timeline for the procedure for amending the documents contained in the registration dossier.

116. If the identified violations are not corrected and/or the missing documents are not provided within the period not exceeding 30 business days, including as specified in paragraph 53 of these Rules, the registering authority shall decide to terminate further consideration of the application for amending the documents contained in the registration dossier that do not require an examination of the quality, effectiveness, and safety of the medical device, with a justified explanation of the reasons for this decision.

117. Within 3 business days from the completion of the verification specified in paragraph 114 of these Rules (in the case of submission of a properly formatted application for amending the documents contained in the registration dossier that do not require an examination of the quality, effectiveness, and safety of the medical device, and a full set of documents as provided in paragraph 112 of these Rules), as well as in the case of elimination of identified violations and/or submission of documents specified in paragraph 112 of these Rules within the 30-business-day period, the registering authority shall decide to initiate the procedure for amending the documents contained in the registration dossier.

118. Within a period not exceeding 10 business days from the date of the decision to initiate the procedure for amending the documents contained in the registration dossier, the registering authority shall carry out the following actions:

a) issue a decision to amend the documents contained in the registration dossier, formalized by an order of the registering authority, and notify the applicant of the decision by placing the corresponding notification in the form of an electronic document signed with a qualified electronic signature of an authorized official in the applicant's unified account and electronic account;

b) make amendments to the registry record.

 

VI. Amendments to Documents Contained in the Registration Dossier Requiring an Examination of the Quality, Effectiveness, and Safety of the Medical Device

 

119. Amendments to the documents contained in the registration dossier, except in cases specified in paragraph 111 of these Rules, shall be made based on the results of examining the quality, effectiveness, and safety of the medical device.

120. To amend the documents contained in the registration dossier, as specified in paragraph 119 of these Rules, the applicant, within 90 business days from the date of the change in the relevant data, shall submit the following to the registering authority via the applicant's unified account:

a) an application for amending the documents contained in the registration dossier requiring an examination of the quality, effectiveness, and safety of the medical device, containing the information specified in paragraph 64 of these Rules and additionally including information about the amendments being made and, where applicable, information on the results of clinical trials of the medical device, including the number, date of the act of evaluating the results of the clinical trials of the medical device, and the name of the medical organization;

b) a copy (copies) of the document(s) confirming the authority of the authorized representative of the manufacturer (producer) to represent the interests of the manufacturer (producer), to bear responsibility for the circulation of the medical device within the territory of the Russian Federation, including matters related to conformity assessment procedures and state registration, as well as to certify the document(s) of the manufacturer (producer) effective before the formalization of the corresponding documents (the document(s) is mandatory for foreign manufacturers (producers); for domestic manufacturers (producers), it is provided if an authorized representative of the manufacturer (producer) is present);

c) documents confirming the possibility of manufacturing at the address(es) specified in the registration application as the production site(s), if applicable: documents confirming the availability of manufacturing conditions, and/or copies of certificates of compliance of the quality management system with the requirements of GOST ISO 13485-2017 or ISO 13485:2016, as well as copies of reports from previous inspections for compliance with these standards (if such certificates of compliance are provided), and/or copies of documents confirming the quality management system's compliance with the requirements for implementing, maintaining, and evaluating the quality management system for medical devices (provided in cases of inspections conducted by an inspection body under the jurisdiction of a state authority of a Eurasian Economic Union member state, excluding the Russian Federation);

d) documents specified in paragraph 65 of these Rules that have undergone relevant changes and confirm that the amendments do not lead to changes in the properties and characteristics of the medical device affecting its safety, quality, and effectiveness, or enhance its properties and characteristics without altering the functional purpose and/or operating principle of the medical device.

The applicant may, at their discretion, submit other documents justifying amendments that do not lead to changes in the properties and characteristics of the medical device affecting its safety, quality, and effectiveness, or that enhance its properties and characteristics without altering the functional purpose and/or operating principle of the medical device.

121. The registering authority is not entitled to require the applicant to include in the application for amendments to the documents contained in the registration dossier requiring an examination of the quality, effectiveness, and safety of the medical device any information or documents not specified in paragraph 120 of these Rules.

122. Within 5 business days from the receipt of the application for amendments to the documents contained in the registration dossier requiring an examination of the quality, effectiveness, and safety of the medical device, and the documents specified in paragraph 120 of these Rules, the registering authority verifies the completeness and accuracy of the information contained therein, including by comparing it with information provided by government authorities under interagency information exchange through the interagency electronic interaction system.

123. If the application for amendments to the documents contained in the registration dossier requiring an examination of the quality, effectiveness, and safety of the medical device is prepared in violation of the provisions of paragraph 64 and subparagraph "a" of paragraph 120 of these Rules, and/or the submitted documents violate the provisions of paragraphs 53–55 of these Rules, and/or the application and submitted documents contain inaccurate information, and/or the documents specified in paragraph 120 of these Rules are incomplete, the registering authority notifies the applicant of the need to eliminate the identified violations and/or provide missing documents within 30 business days from the posting of such notification as an electronic document signed with a qualified electronic signature of an authorized official in the applicant's unified account and electronic account. The applicant must address the identified violations and/or submit the missing documents via the unified account.

The time from the notification by the registering authority to the receipt of a response or notification of no response from the applicant is not included in the timeframe for the procedure for amendments to the documents contained in the registration dossier.

124. Within 3 business days from the completion of the verification specified in paragraph 122 of these Rules (in the case of a properly prepared application for amendments to the documents contained in the registration dossier requiring an examination of the quality, effectiveness, and safety of the medical device, and a complete set of documents as specified in paragraph 120 of these Rules), as well as in the case of rectification of identified violations and/or submission of documents specified in paragraph 120 of these Rules within the 30-business-day period, the registering authority decides to initiate the procedure for amendments to the documents contained in the registration dossier.

125. If, within 30 business days, the identified violations are not rectified and/or the missing documents are not submitted, including taking into account the provisions of paragraph 53 of these Rules, the registering authority decides to terminate further consideration of the application for amendments to the documents contained in the registration dossier requiring an examination of the quality, effectiveness, and safety of the medical device, and the documents specified in paragraph 120 of these Rules, and informs the applicant by posting the corresponding notification, with a reasoned justification for the decision, as an electronic document signed with a qualified electronic signature of an authorized official in the applicant's unified account and electronic account.

126. Amendments to the documents contained in the registration dossier requiring an examination of the quality, effectiveness, and safety of the medical device are carried out by the registering authority within 36 business days from the receipt of the application for amendments to the documents contained in the registration dossier requiring an examination of the quality, effectiveness, and safety of the medical device, and the documents specified in paragraph 120 of these Rules.

127. Within 3 business days from the decision to initiate the procedure for amendments to the documents contained in the registration dossier, the registering authority prepares and issues a task for an examination to the expert institution.

128. The examination of the application for amendments to the documents contained in the registration dossier requiring an examination of the quality, effectiveness, and safety of the medical device, and the documents specified in paragraph 120 of these Rules, is carried out simultaneously with the examination of the completeness and results of tests and studies within 15 business days from the receipt of the task by the expert institution from the registering authority.

129. During the examination of the quality, effectiveness, and safety of the medical device, the expert institution is not allowed to request materials necessary for the examination from the applicant or other persons.

If the materials and information contained in the application for amendments to the documents included in the registration dossier, requiring an examination of the quality, effectiveness, and safety of the medical device, as well as in the documents specified in paragraph 120 of these Rules, submitted by the applicant, are insufficient for the expert to draw a conclusion, the expert raises the issue of providing the necessary materials and information to the head of the expert institution. The head of the expert institution then submits the corresponding request to the registering authority that issued the task for the examination. This request must include a comprehensive list of all questions, materials, and information required by the expert to conduct the examination.

The registering authority, within 2 business days from the date of receipt of the request from the head of the expert institution, sends the applicant a request for the provision of the necessary information, indicating the nature of the comments and the method for their correction. This request is sent only once in the form of an electronic document signed with a qualified electronic signature of the authorized official, by placing it in the applicant's electronic account and unified personal account.

The applicant is required to respond to the request from the registering authority via the unified personal account within 50 business days from the date of sending the request. Within 2 business days of receiving the applicant's response to the request, the registering authority forwards this response to the expert institution. In the event of non-submission of the response by the applicant after 50 business days, the registering authority, within 2 business days, sends a notification to the expert institution about the applicant's failure to respond to the request. This notification is used to prepare a conclusion on the feasibility (or infeasibility) of introducing amendments to the documents included in the registration dossier, the format of which is approved by the Ministry of Health of the Russian Federation (hereinafter referred to as the conclusion on amendments to the documents included in the registration dossier), based on the documents available at its disposal.

The time from the date the registering authority sends the request to the date the response to the request or notification of non-response is received is not included when calculating the timeframe for conducting the examination of the quality, effectiveness, and safety of the medical device.

If the registering authority identifies inaccurate and/or insufficient data or documents presented by the applicant in response to the request, or inconsistencies in the format of the presented documents with the provisions of points 53–55 of these Rules, the registering authority, within 2 business days, sends the applicant (in the form of an electronic document signed with an enhanced qualified electronic signature of the authorized official and placed in the unified personal account and the electronic account of the applicant) a reasoned decision on the possibility of resubmission by the applicant of revised documents within 50 business days from the date of the request. If the applicant fails to submit the requested documents and information within the specified period, the examination of the quality, effectiveness, and safety of the medical device continues based on the documents and information previously provided by the applicant and contained in the registration dossier.

130. The expert institution, within 15 business days from the date of receipt of the documents specified in paragraph 120 of these Rules, conducts the examination provided for in paragraph 127 of these Rules and submits the conclusion on amendments to the documents included in the registration dossier to the registering authority.

131. The grounds for the expert institution to issue a conclusion on amendments to the documents included in the registration dossier, indicating the infeasibility of making amendments, are as follows:

a) inaccuracy of the information provided to justify the amendments, including inaccuracies identified by the registering authority based on the results of state control (supervision) over the circulation of medical devices;

b) absence in the documents submitted by the applicant of information confirming that the proposed amendments to the documents included in the registration dossier do not alter the properties and characteristics affecting the quality, effectiveness, and safety of the medical device, or improve its properties and characteristics while maintaining the functionality and/or principle of operation;

c) lack of information confirming the unchanged functionality and/or principle of operation of the medical device due to the proposed amendments to the documentation;

d) the necessity to conduct a new state registration of the medical device in accordance with paragraph 110 of these Rules;

e) existence of inaccurate information in the documents included in the registration dossier.

132. Within 10 business days from the date of receipt of the conclusion on amendments to the documents included in the registration dossier, the registering authority undertakes the following actions:

a) evaluates the conclusion on amendments to the documents included in the registration dossier to determine compliance with the assignment for the examination. If the conclusion does not comply with the specified assignment, it is returned to the expert institution for revision, which must be completed within 2 business days from the date the expert institution receives the returned conclusion;

b) in the case of receiving the conclusion on amendments to the documents included in the registration dossier as provided in paragraph 131 of these Rules, no later than the next business day after evaluating such a conclusion to determine compliance with the task for conducting the examination, the registering authority places an electronic copy of this conclusion in the applicant's electronic account and sends the corresponding information to the applicant's unified personal account.

Within 10 business days from the date the conclusion on amendments to the documents contained in the registration dossier, specified in paragraph 131 of these Rules, is posted in the applicant's electronic account, the applicant has the right to review the conclusion and, if objections exist, submit them via the electronic account.

If the applicant's objections to the conclusion specified in paragraph 131 of these Rules are submitted via the electronic account within a period not exceeding 10 business days, the registering authority reviews them within 30 business days from the date of receipt, involving the expert institution that issued the conclusion. If objections are not received within the established period, the registering authority undertakes the measures specified in subparagraphs "v" and "g" of this paragraph. When reviewing objections, the registering authority involves the applicant if clarifications are necessary.

Based on the results of the review of objections, a decision is made to recognize the objections as fully or partially justified, which is formalized in a letter from the registering authority and sent to the expert institution along with the conclusion on making changes to the documents contained in the registration dossier, as provided for in paragraph 131 of these Rules, for revision, the period for which shall not exceed 5 business days from the date the expert institution receives the returned conclusion on making changes to the documents contained in the registration dossier, or to recognize the objections as fully unjustified.

The period from the day the registering authority places the conclusion on amendments to the documents contained in the registration dossier, as specified in paragraph 131 of these Rules, in the applicant's electronic account until the decision based on the consideration of objections is made shall not be included in the calculation of the timeframe for conducting the examination of the quality, safety, and effectiveness of the medical device;

c) making a decision on the possibility (or impossibility) of amending the documents contained in the registration dossier, which is formalized by an order of the registering authority, and notifying the applicant of the decision made by sending a corresponding notification in the form of an electronic document signed with the enhanced qualified electronic signature of an authorized official or by placing it in the unified personal account of the applicant and the applicant's electronic account;

d) introducing amendments to the register entry (if a decision on the possibility of amending the documents contained in the registration dossier has been made).

133. The grounds for making a decision to refuse amendments to the documents contained in the registration dossier are:

a) receipt by the registering authority from the expert institution of a conclusion on amendments to the documents contained in the registration dossier indicating the impossibility of amending the documents contained in the registration dossier and/or the registering authority's decision to recognize the applicant's objections as fully or partially unjustified;

b) identification by the registering authority, based on the results of federal state control (supervision) over the circulation of medical devices, of discrepancies between the data on the effectiveness and safety of the medical device and the data on the medical device contained in the application for amendments to the documents in the registration dossier requiring the conduct of an examination of the quality, safety, and effectiveness of the medical device, and the documents specified in paragraph 120 of these Rules.

 

VII. Features of Making Amendments to the Documents Contained in the Registration Dossier for Software Utilizing Artificial Intelligence Technologies as a Medical Device

 

134. Amendments to the documents contained in the registration dossier for software utilizing artificial intelligence technologies as a medical device:

a) if the software utilizing artificial intelligence technologies as a medical device lacks a built-in function for automatic transmission, in a manner approved by the registering authority, to the registering authority's automated information system of data on processed information, results of the software's operation, and information stipulated by the procedure for reporting by entities involved in the circulation of medical devices on all cases of adverse effects, such amendments shall be carried out in accordance with paragraphs 110–133 of these Rules (if applicable);

b) regarding version numbering changes that do not affect the functional purpose and/or principle of operation of the software utilizing artificial intelligence technologies as a medical device, provided such software includes a built-in function for automatic transmission, in a manner approved by the registering authority, to the registering authority's automated information system of data on processed information, results of the software's operation, and information stipulated by the procedure for reporting by entities involved in the circulation of medical devices on all cases of adverse effects, such amendments shall be carried out in accordance with paragraphs 119–133 or 135 and 136 of these Rules.

135. To make amendments to the documents contained in the registration dossier for software utilizing artificial intelligence technologies as a medical device, specifically to update its version numbering without affecting its functional purpose and/or principle of operation, the applicant shall submit via the applicant's unified personal account to the registering authority an application for amending the documents contained in the registration dossier for software utilizing artificial intelligence technologies as a medical device, which must include the following information:

a) the name of the medical device;

b) information on the registration number and the date of state registration of the medical device (or the date of amendments to the documents contained in the registration dossier);

c) regarding the applicant: the full and abbreviated (if applicable) name, organizational and legal form, taxpayer identification number (if applicable), and the address of the location for a legal entity; or the surname, first name, patronymic (if applicable), identity document details, taxpayer identification number (if applicable), and residential address for an individual registered as an individual entrepreneur, as well as the phone number and email address of the legal entity or individual registered as an individual entrepreneur;

d) information about the version of the software utilizing artificial intelligence technologies as a medical device, which must be included in the state register;

e) information identifying the results of clinical trials of the software utilizing artificial intelligence technologies as a medical device (including the number, date of the act on clinical trials of the medical device, and the name of the medical organization);

f) information on the payment of the state fee (date and number of the payment order);

g) information on the applicant’s responsibility for the accuracy and consistency of the information contained in the registration dossier and the application for amending the documents contained in the registration dossier for the software utilizing artificial intelligence technologies as a medical device.

136. Within 5 business days from the date of receipt of the application for amending the documents contained in the registration dossier for the software utilizing artificial intelligence technologies as a medical device, the registering authority conducts a review of the completeness and accuracy of the information contained therein, including by comparing such information with data provided by government authorities under the framework of interdepartmental information interaction through the interdepartmental electronic interaction system. Within 5 business days after completing the review:

a) if the submitted application for amending the documents contained in the registration dossier for the software utilizing artificial intelligence technologies as a medical device is properly completed, the registering authority adopts a decision on amending the documents contained in the registration dossier. This decision is formalized by an order of the registering authority, and the applicant is informed of the decision by posting an appropriate notification in the form of an electronic document signed with the enhanced qualified electronic signature of an authorized official in the applicant’s unified personal account and electronic personal account. The registering authority also makes changes to the register entry;

b) If the submitted application for amending the documents contained in the registration dossier for the software utilizing artificial intelligence technologies as a medical device contains inaccurate information or the information required under paragraph 135 of these Rules is not provided in full, the registering authority adopts a decision to terminate further consideration of the application for amending the documents contained in the registration dossier for the software utilizing artificial intelligence technologies as a medical device. The registering authority informs the applicant of this decision by posting an appropriate notification, including a reasoned justification for the adoption of such a decision, in the form of an electronic document signed with the enhanced qualified electronic signature of an authorized official in the applicant’s unified personal account and electronic personal account.

 

VIII. Revocation of the State Registration of a Medical Device

 

137. The registering authority shall adopt a decision to revoke the state registration of a medical device in the following cases:

a) Submission by the applicant, via the applicant's unified personal account, of an application for the revocation of the state registration of the medical device, containing the information specified in paragraph 138 of these Rules;

b) issuance of a court decision confirming the violation of the rights of the intellectual property owner regarding the results of intellectual activity and equivalent means of individualization in the circulation of medical devices (or their models/brands);

c) submission by the federal executive authority authorized by the Government of the Russian Federation of information, based on the results of federal state control (oversight) over the circulation of medical devices, confirming facts and circumstances that pose a threat to the life and health of citizens and healthcare workers during the use and operation of medical devices;

d) identification by the registering authority, based on the results of federal state control (oversight) over the circulation of medical devices, of inaccurate information in the documents contained in the registration dossier submitted by the applicant, which affected the results of the quality, effectiveness, and safety examination of the medical device;

e) Receipt by the registering authority of a conclusion from the expert institution stating that the instrument, apparatus, device, equipment, material, and other items listed in the state register, based on their functional purpose and/or principle of operation, cannot be used for medical purposes and/or do not constitute medical devices. The conclusion from the expert institution stating that the instrument, apparatus, device, equipment, material, and other items listed in the state register, based on their functional purpose and/or principle of operation, cannot be used for medical purposes and/or do not constitute medical devices shall be submitted (sent) by the expert institution to the registering authority within 10 business days from the date of receipt by the expert institution of the corresponding assignment from the registering authority, accompanied by the documents contained in the registration dossier.

In the event that the registering authority receives a conclusion from the expert institution indicating that an instrument, apparatus, device, equipment, material, or other items may be used for medical purposes and/or classified as a medical device after amendments are made to the documents contained in the registration dossier, and/or indicating that the decision on the impossibility of using the instrument, apparatus, device, equipment, material, or other items for medical purposes and/or their classification as medical devices applies only to certain registered models (brands) of the medical device, the registering authority, prior to adopting a decision to revoke the state registration of the medical device, shall:

notify the applicant by placing the corresponding notification in the form of an electronic document signed with the enhanced qualified electronic signature of an authorized official in the applicant's electronic account. The notification shall include the expert institution's conclusion stating that the instrument, apparatus, device, equipment, material, or other items listed in the state register, based on their functional purpose and/or principle of operation, cannot be used for medical purposes and/or are not medical devices. The notification will also specify the requirement to amend the documents contained in the registration dossier within a period not exceeding 180 business days from the date of the notification;

adopt a decision to suspend the state registration of the medical device for a period of 180 business days from the date the notification on the need to amend the documents in the registration dossier is sent;

f) failure to amend the documents contained in the registration dossier confirming the authority of the manufacturer's (producer's) authorized representative to represent the manufacturer (producer) and assume responsibility for the circulation of the medical device within the territory of the Russian Federation, including matters related to conformity assessment and state registration procedures as specified in subparagraphs "a" or "d" of paragraph 111 of these Rules, within 90 business days from the expiration date of the relevant document, or the absence of information in the registration dossier regarding the appointment of the manufacturer's (producer's) authorized representative within 90 business days from the effective date of the requirements specified in the second paragraph of paragraph 29 of these Rules.

Before adopting a decision to revoke the state registration of a medical device in the case outlined in the first paragraph of this subparagraph, the registering authority shall: adopt a decision to suspend the state registration of the medical device for a period of 90 business days from the expiration date of the document confirming the authority of the manufacturer's (producer's) authorized representative to represent the manufacturer (producer) and assume responsibility for the circulation of the medical device within the Russian Federation, including matters related to conformity assessment and state registration, or from the date specified in the second paragraph of paragraph 29 of these Rules; simultaneously notify all participants in the medical device circulation sector via an information letter published on the official website of the registering authority on the Internet and through the applicant's electronic account. Alternatively, the manufacturer (producer) of the medical device shall be notified of the need to update information regarding the authorized representative of the manufacturer (producer).

g) absence of information in the register of conclusions on compliance with the requirements for the implementation, maintenance, and assessment of the medical device quality management system regarding the conducted periodic (planned) inspections, or failure to amend the documents contained in the registration dossier in accordance with subparagraph "a" of paragraph 111 of these Rules within a period not exceeding 90 business days from the expiration date of the inspection report (for medical devices that have undergone initial production inspection, except for medical devices of potential risk class 1 and non-sterile medical devices of potential risk class 2a).

Before making a decision to revoke the state registration of a medical device under the conditions specified in the first paragraph of this subparagraph, the registering authority adopts a decision to suspend the state registration of the medical device for a period of 180 business days from the expiration date of the inspection report or from the issuance of a negative conclusion following periodic (planned) or unplanned inspections. Simultaneously, it notifies all participants in the medical device circulation sector via an information letter published on the official website of the registering authority on the Internet and through the applicant's personal account or by sending a notification to the manufacturer (producer) and the authorized representative of the manufacturer (producer) about the need to conduct a periodic (planned) or unplanned inspection;

h) detection by the registering authority of changes made to the documents contained in the registration dossier for software utilizing artificial intelligence technologies that is classified as a medical device, for reasons other than those specified in paragraph 135 of these Rules;

i) failure to submit to the registering authority a clinical monitoring report for the medical device in accordance with the procedure for reporting all cases of adverse effects by entities involved in the circulation of medical devices.

Before making a decision to revoke the state registration of a medical device under the conditions specified in the first paragraph of this subparagraph, the registering authority adopts a decision to suspend the state registration of the medical device for a period of 30 business days from the date established by the procedure for reporting all cases of adverse effects by entities involved in the circulation of medical devices. Simultaneously, it notifies all participants in the medical device circulation sector via an information letter published on the official website of the registering authority on the Internet and through the applicant's electronic account or by sending the applicant a notification about the need to submit a clinical monitoring report for the medical device;

j) detection by the registering authority of false information in the documents submitted by the applicant during the state registration procedure for the medical device;

k) classification of a previously registered medical device as one of the medical devices specified in paragraph 5 of part 5 of Article 38 of the Federal Law "On the Fundamentals of Health Protection of Citizens in the Russian Federation".

138. The application for revoking the state registration of a medical device, as specified in subparagraph "a" of paragraph 137 of these Rules, must include the following information:

a) name of the medical device (including the models (brands) of the medical device, their composition, and accessories necessary for the use of the medical device or its models (brands) as intended, if applicable);

b) regarding the manufacturer (producer) of the medical device: the full and abbreviated (if available) name (with transliteration), organizational and legal form, taxpayer identification number (if available), address of the location (for a legal entity), or surname, first name, and patronymic (if available), identity document details, taxpayer identification number (if available), address of residence (for an individual registered as an individual entrepreneur), as well as the phone number and email address of the legal entity or the individual registered as an individual entrepreneur;

c) regarding the authorized representative of the manufacturer (producer): the full and abbreviated (if available) name, organizational and legal form, taxpayer identification number, address of the location (for a legal entity), or surname, first name, and patronymic (if available), identity document details, taxpayer identification number, address of residence (for an individual registered as an individual entrepreneur), as well as the phone number and email address of the legal entity or the individual registered as an individual entrepreneur;

d) the date of state registration of the medical device (or amendments to the documents contained in the registration dossier) and its registration number;

e) information on the reasons for submitting the application for the revocation of the state registration of the medical device;

f) details of the applicant's responsibility for the accuracy and consistency of the information contained in the submitted documents and the application for the revocation of the state registration of the medical device.

139. The application for the revocation of the state registration of a medical device, as specified in subparagraph "a" of paragraph 137 of these Rules, may be submitted by the authorized representative of the manufacturer (producer) if the following conditions are met simultaneously:

a) the registration dossier contains a valid document confirming the authority of the authorized representative of the manufacturer (producer) to represent the interests of the manufacturer (producer), to bear responsibility for the circulation of the medical device on the territory of the Russian Federation, including matters related to conformity assessment procedures and state registration, as well as to certify documents of the manufacturer (producer), which took effect prior to the issuance of the relevant documents, or the submission of such a document to the registering authority in accordance with the requirements of paragraph 53 of these Rules together with the application for the revocation of the state registration of the medical device;

b) the following documents are submitted to the registering authority together with the application for the revocation of the state registration of the medical device:

a letter from the manufacturer (producer) confirming its intention to revoke the state registration of the medical device (in cases where the application for the revocation of the state registration of the medical device is submitted by the authorized representative of the manufacturer (producer));

a copy (or copies) of the document (or documents) confirming the authority of the authorized representative of the manufacturer (producer) to represent the interests of the manufacturer (producer), to bear responsibility for the circulation of the medical device on the territory of the Russian Federation, including matters related to conformity assessment procedures and state registration of the medical device, as well as to certify the document (or documents) of the manufacturer (producer), which took effect prior to the issuance of the relevant documents (if a valid document is absent from the registration dossier) (the document (or documents) is (are) mandatory for foreign manufacturers (producers); domestic manufacturers (producers) must submit them if an authorized representative of the manufacturer (producer) is present).

140. If the application for the revocation of the state registration of the medical device is submitted in violation of the requirements of paragraph 139 of these Rules, and/or the submitted documents are prepared in violation of the provisions of paragraphs 53–55 of these Rules, and/or the application for the revocation of the state registration of the medical device and the submitted documents contain inaccurate information, and/or the documents specified in paragraph 139 of these Rules are not submitted in full, the registering authority, within 7 business days from the date of receipt of such an application and documents, makes a decision to terminate further consideration of the application with a reasoned justification for the decision.

141. The registering authority, within 7 business days from the occurrence of one of the cases specified in paragraph 137 of these Rules, shall:

a) make a decision on the revocation of the state registration of the medical device;

b) enter a record of the revocation of the state registration into the state register;

c) inform the applicant about the revocation of the state registration of the medical device by placing the corresponding notification in the form of an electronic document, signed with an enhanced qualified electronic signature of the authorized official, in the unified personal account of the applicant and the electronic account of the applicant.

 

 

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APPENDIX

to the Rules for State Registration of Medical Devices

 

(Form)

 

Ministry of Health of the Russian Federation

 

ETHICS COUNCIL

 

Date of the Ethics Council meeting: ________ ____, 20__

 

CONCLUSION

on the ethical justification for conducting clinical trials
of a medical device

 

No.______ dated ________ ____, 20__

 

1. Name of the medical device (including accessories necessary for the intended use of the medical device)

______________________________________________________________________

2. Manufacturer of the medical device
______________________________________________________________________                                            (full and abbreviated name (if any),

______________________________________________________________________

legal form of the legal entity, address of its registered office, or full name, address of residence for an individual registered as a sole proprietor)

3. Applicant
______________________________________________________________________

4. Decision: ______________________________________________________________________

(information on the ethical justification for conducting

______________________________________________________________________

clinical trials of the medical device, reasons

______________________________________________________________________

for the decision regarding the impossibility of conducting

______________________________________________________________________

clinical trials of the medical device)

 

Chairperson of the Council	_____________________ (full name)	___________________ (signature)
Experts	_____________________ (full name)	___________________ (signature)

 

 

____________

 

APPENDIX

to the Resolution of the Government

of the Russian Federation

dated November 30, 2024, No. 1684

 

LIST

of Acts of the Government of the Russian Federation that have become invalid

 

1. Resolution of the Government of the Russian Federation dated December 27, 2012, No. 1416, "On Approval of the Rules for State Registration of Medical Devices" (Collection of Legislation of the Russian Federation, 2013, No. 1, Article 14).

2. Resolution of the Government of the Russian Federation dated October 17, 2013, No. 930, "On Amendments to the Resolution of the Government of the Russian Federation No. 1416 dated December 27, 2012" (Collection of Legislation of the Russian Federation, 2013, No. 43, Article 5556).

3. Resolution of the Government of the Russian Federation dated July 17, 2014, No. 670, "On Amendments to the Rules for State Registration of Medical Devices" (Collection of Legislation of the Russian Federation, 2014, No. 30, Article 4310).

4. Resolution of the Government of the Russian Federation dated February 10, 2017, No. 160, "On Amendments to the Resolution of the Government of the Russian Federation No. 1416 dated December 27, 2012" (Collection of Legislation of the Russian Federation, 2017, No. 8, Article 1233).

5. Resolution of the Government of the Russian Federation dated May 31, 2018, No. 633, "On Amendments to the Rules for State Registration of Medical Devices" (Collection of Legislation of the Russian Federation, 2018, No. 24, Article 3523).

6. Resolution of the Government of the Russian Federation dated March 18, 2020, No. 299, "On Amendments to the Rules for State Registration of Medical Devices" (Collection of Legislation of the Russian Federation, 2020, No. 12, Article 1792).

7. Resolution of the Government of the Russian Federation dated September 1, 2020, No. 1335, "On Amending Clause 2 of the Rules for State Registration of Medical Devices" (Collection of Legislation of the Russian Federation, 2020, No. 36, Article 5637).

8. Resolution of the Government of the Russian Federation dated November 24, 2020, No. 1906, "On Amending the Rules for State Registration of Medical Devices" (Collection of Legislation of the Russian Federation, 2020, No. 49, Article 7897).

 

 

___________

 

APPROVED

by Resolution of the Government

of the Russian Federation

dated November 30, 2024, No. 1684

 

AMENDMENTS

to be introduced into the Acts of the Government of the Russian Federation

 

1. In the Resolution of the Government of the Russian Federation dated December 31, 2020, No. 2467, "On the approval of the list of regulatory legal acts and groups of regulatory legal acts of the Government of the Russian Federation, regulatory legal acts, individual provisions of regulatory legal acts and groups of regulatory legal acts of federal executive authorities, legal acts, individual provisions of legal acts, groups of legal acts of executive and administrative authorities of the RSFSR and the USSR, decisions of the State Commission on Radio Frequencies containing mandatory requirements, in relation to which the provisions of Parts 1, 2, and 3 of Article 15 of the Federal Law 'On Mandatory Requirements in the Russian Federation' do not apply" (Collected Legislation of the Russian Federation, 2021, No. 2, Art. 471; 2022, No. 23, Art. 3785; 2024, No. 25, Art. 3505; No. 33, Art. 5163; No. 38, Art. 5651; No. 40, Art. 5981; No. 42, Art. 6257; No. 44, Art. 6619):

a) in paragraph 10, remove the digits "637."

b) in the list of regulatory legal acts and groups of regulatory legal acts of the Government of the Russian Federation, regulatory legal acts, individual provisions of regulatory legal acts and groups of regulatory legal acts of federal executive authorities, legal acts, individual provisions of legal acts, groups of legal acts of executive and administrative authorities of the RSFSR and the USSR, and decisions of the State Commission on Radio Frequencies containing mandatory requirements, to which the provisions of Parts 1, 2, and 3 of Article 15 of the Federal Law "On Mandatory Requirements in the Russian Federation" do not apply, exclude item 637.

2. In the second paragraph of item 6 of the changes introduced into the Resolution of the Government of the Russian Federation dated December 31, 2020, No. 2467, approved by the Resolution of the Government of the Russian Federation dated June 12, 2024, No. 792 "On Amending Certain Acts of the Government of the Russian Federation" (Collected Legislation of the Russian Federation, 2024, No. 25, Art. 3505), remove the digits "637".

___________