Council of the Eurasian Economic Commission Decision No. 46

ON THE RULES FOR REGISTRATION AND EXAMINATION OF SAFETY, QUALITY AND EFFECTIVENESS OF MEDICAL DEVICES

(as amended by Decisions of the Council of the Eurasian Economic Commission on 24.12.2021 no.144, of 19.05.2022 no.84, of 30.03.2023 no.50)

In accordance with paragraph 2 of  Article 31of the Treaty on the Eurasian Economic Union of 29 May, 2014, paragraphs 2 and 4 of Article 4 of the Agreement on Common Principles and Rules for the Circulation of Medical Devices (Medical Products and Medical Equipment) within the Eurasian Economic Union of 23 December, 2014, paragraph 92 of Appendix n.1 to the Rules of Procedure of the Eurasian Economic Commission, approved by the Decision of the Supreme Eurasian Economic Council of 23 December, 2014 no.98, and in order to implement the Decision of the Supreme Eurasian Economic Council of 23 December, 2014 no.109 "On the Implementation of the Agreement on Common Principles and Rules for the Circulation of Medical Devices (Medical Products and Medical Equipment) within the Eurasian Economic Union," the Council of the Eurasian Economic Commission decided:

 

1. To approve the attached Rules for registration and examination of safety, quality and effectiveness of medical devices (hereinafter referred to as the Rules).

2. Paragraph lost its force (as amended by the Decision of the Council of the Eurasian Economic Commission of 30.03.2023 no.50).

3. Member States shall, by 31 December, 2016:

 

a) Approve the amount of government fees (duties) or other mandatory payments provided for by the Rules, taking into account the complexity of the procedures and the amount of work performed in the reference State and the States of recognition, including:

Registration of a medical device;

Examination of safety, quality and effectiveness of a medical device;

Making changes to the registration dossier of a medical device;

Issuing duplicates of registration certificates;
  b) Identify the bodies (organizations) responsible for carrying out registration, making changes to the registration dossier and other procedures related to the registration of medical devices provided for by the Rules, and inform the Eurasian Economic Commission about this.

4. This Decision shall enter into force upon the expiration of 10 calendar days from the date of entry into force of the Protocol signed on 2 December, 2015, on the accession of the Republic of Armenia to the Agreement on Common Principles and Rules for the Circulation of Medical Devices (Medical Products and Medical Equipment) within the Eurasian Economic Union of 23 December, 2014, but no earlier than upon the expiration of 10 calendar days from the date of official publication of this Decision.

Members of the Council of the Eurasian Economic Commission:
From the Republic of Armenia V. GABRIELYAN

From the Republic of Belarus V. MATYUSHEVSKY

From the Republic of Kazakhstan B. SAGINTAEV

From the Kyrgyz Republic O. PANKRATOV

From the Russian Federation I. SHUVALOV 

 

APPROVED

by the Decision of the Council of the Eurasian Economic Commission of 12 February, 2016,  no. 46

RULES FOR REGISTRATION AND EXAMINATION OF SAFETY, QUALITY AND EFFECTIVENESS OF MEDICAL DEVICES
(as amended by Decisions of the Council of the Eurasian Economic Commission of 24.12.2021 no. 144, of 30.03.2023 no. 50)

I. General 

1. These Rules have been developed in accordance with paragraph 2 of Article 31 of the Treaty on the Eurasian Economic Union of 29 May, 2014, and paragraph 2 of Article 4 of the Agreement on Common Principles and Rules for the Circulation of Medical Devices (Medical Products and Medical Equipment) within the Eurasian Economic Union of 23 December, 2014, and establish the procedure for carrying out the procedures for registration and examination of the safety, quality and effectiveness of medical devices (hereinafter referred to as the examination), agreeing on an expert opinion, resolving disagreements regarding the agreement of an expert opinion, making changes to the registration dossier (including in a notification procedure), issuing a duplicate of the registration certificate of a medical device, agreeing on an expert opinion on a registered medical device, as well as suspending and/or revoking (annulling) the registration certificate of a medical device within the Eurasian Economic Union (hereinafter referred to as the Union).
  The requirements of these Rules may not apply to medical devices, the need for which arises or increases in emergencies, in conditions of military operations, the threat of the spread of new epidemic diseases that pose a danger to others, with the threat of absence or absence of medical devices in the markets of the Member States of the Union (hereinafter - the Member States) under conditions of introduction of restrictive economic measures in relation to at least one of the Member States. The circulation of such medical devices on the territories of the Member States is regulated by the legislation of these Member States during the period of these conditions and the elimination of their consequences. (as amended by the Decision of the Council of the Eurasian Economic Commission of 30.03.2023 n. 50)

2. For the purposes of these Rules, the following definitions are used, which mean the following:

"Safety of medical devices" means the absence of unacceptable risk related to causing harm to life, human health, and the environment;

  "Validation" means confirmation by presenting objective evidence of compliance with requirements intended for a specific use or application;

"Verification" means confirmation based on the presentation of objective evidence of compliance with established requirements;

 "State of recognition" means a Member State whose authorized body (expert organization) carries out the procedure for agreeing on the expert opinion of the reference State;

"First-party evidence" means evidentiary materials (documents) of the medical device manufacturer (protocols of its own tests (studies), including those issued by testing laboratories (centers) accredited in the national accreditation system of the Member State, results of clinical application of the medical device, and other materials);

"Common register of medical devices registered within the Eurasian Economic Union" means an electronic database of medical devices registered in accordance with these Rules;

"Applicant" means a legal manufacturer of a medical device or his authorized representative;

"Quality of a medical device" means the degree of conformity of the set of properties and characteristics of a medical device to the purpose established by the manufacturer;

"Medical devices for in vitro diagnostics" means any instruments, apparatus, devices, equipment, materials, reagents, calibrators, control materials, and other products used for medical purposes separately or in combination, as well as together with accessories and special software necessary for their use as intended, and intended by the manufacturer for use in in vitro studies of human biological material samples to obtain information regarding the physiological or pathological condition (congenital pathology, predisposition to a specific clinical condition or disease), tissue compatibility with a potential recipient, predicting responses to therapeutic interventions, selecting therapeutic agents, and/or monitoring treatment;

"Model (brand) of a medical device" means a variant of the medical device characterized by certain design and technological solutions and specific values of indicators of its target (functional) purpose;

"Accessory" means a product that is not a medical device, intended by its manufacturer for joint use with one or more medical devices when used in accordance with their intended purpose;

"Manufacturer of a medical device", "Manufacturer" means 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 on its own behalf, regardless of whether the medical device was developed and/or manufactured by this person or on its behalf by another person (persons), and bearing responsibility for the safety, quality and effectiveness of the medical device;

"Production site" means a territorially isolated complex intended for carrying out the entire process of manufacturing a medical device or its certain stages;

"Registration dossier" means a set of documents and materials of a defined structure, submitted by the applicant during the procedures for registration and examination, agreement of the expert opinion, making changes to the registration dossier (including in a notification procedure), issuing a duplicate of the registration certificate of the medical device, agreement of the expert opinion on the registered medical device, revocation (annulment) of the registration certificate of the medical device, as well as originals and/or copies of other documents related to a specific medical device (decisions of authorized bodies (expert organizations), minutes of meetings of the Advisory Committee on Medical Devices at the Eurasian Economic Commission, documents submitted during the resolution of disagreements, reports on the results of production inspections, etc.);

"Registration certificate" means a document of a uniform form, confirming the fact of registration of a medical device in the territory of one or more Member States;

"Registration of a medical device," "Registration" means the procedure for issuing by the authorized body of the reference State a permit for the release into circulation of a medical device in the territory of one or more Member States;

"Reference state" means a member state selected by the applicant, the authorized body (expert organization) of which carries out registration and examination;

"Authorized body" means the state authority of a member state authorized to carry out and (or) coordinate activities in the field of medical device circulation on the territory of that member state;

"Authorized organizations" means organizations included in the common register of authorized organizations entitled to conduct research (testing) of medical devices for the purpose of their registration;

"Authorized representative of the manufacturer" means a legal entity or individual registered as an individual entrepreneur, who are residents of a member state and authorized by the manufacturer in accordance with an agreement or other document provided for by the legislation of the member states to represent his interests and be responsible for the circulation of the medical device within the Union and for fulfilling the mandatory requirements for medical devices.

 

3. Registration of a medical device is a mandatory condition for its release into circulation in the territory of one or more member states and is carried out by the authorized body of the reference state. In this case, the same requirements are imposed on medical devices manufactured in the customs territory of the Union and imported into the customs territory of the Union from third countries.

4. For the purpose of registering a medical device, an examination is carried out by an expert organization determined by the authorized body of the member state (hereinafter referred to as the expert organization).

5. The document confirming the fact of registration of a medical device is a registration certificate, drawn up in the form and according to the rules in accordance with Appendix no. 1.

 The registration certificate is issued indefinitely and is valid in the territory of one or more member states.

6. The registered medical device must comply with the Common Requirements for the Safety and Effectiveness of Medical Devices, Requirements for their labeling and operational documentation, approved by the Decision of the Council of the Eurasian Economic Commission of February 12, 2016 no.27 (hereinafter referred to as the Common Requirements). The manufacturer (authorized representative of the manufacturer) is responsible for the compliance of medical devices with the Common Requirements.

7. Manufacturers from third countries must appoint an authorized representative of the manufacturer, acting during the period of circulation of the medical device within the Union, and maintain up-to-date information about such a representative of the manufacturer contained in the registration dossier.

8. The manufacturer ensures the implementation and maintenance in an up-to-date state of the quality management system of the medical device in accordance with the Requirements for the Implementation, Maintenance and Assessment of the Quality Management System of Medical Devices depending on the potential risk of their use, approved by the Decision of the Council of the Eurasian Economic Commission on 10 November, 2017 no.106 (hereinafter referred to as the Requirements for the Quality Management System).

9. Before submitting to the authorized body (expert organization) of the reference state an application for examination of a medical device and an application for registration of a medical device in the forms according to Appendices no.2 and 3 (hereinafter referred to as the application for registration and examination), the applicant collects evidence of the safety and effectiveness of the medical device and prepares the corresponding registration dossier.

10. In order to prepare the registration dossier, the applicant (if necessary):
a) Has the right to apply to the authorized body (expert organization) for preliminary consultations on issues related to registration and examination, including on a reimbursable basis, in accordance with the procedure established by the authorized body (expert organization) of the relevant member state;

b) In order to confirm the compliance of the medical device with the Common Requirements:

• Conducts technical tests, tests (studies) to assess the biological effect of the medical device, clinical and clinical laboratory tests (studies) of the medical device or includes existing data (first-party evidence) in the registration dossier;

• Conducts tests for the purpose of approving the type of measuring instruments (in relation to medical devices included in the list of types of medical devices to be classified as measuring instruments upon their registration, approved by the Decision of the Council of the Eurasian Economic Commission on 12 February, 2016 no. 42) in accordance with the procedure established by the legislation of the member state in the field of ensuring the uniformity of measurements, in organizations selected by the applicant, authorized (notified) in accordance with the legislation of the member state to conduct tests of measuring instruments;

c) Ensures periodic (scheduled) or unscheduled production inspections for the purpose of assessing production conditions and assessing the manufacturer's quality management system in accordance with the Requirements for the Quality Management System.

 

11. During registration and examination, authorized bodies (expert organizations) mutually recognize the results of the tests (studies) specified in subparagraph "b" of paragraph 10 of these Rules, provided that they are performed in accordance with the Rules for Conducting Technical Tests of Medical Devices, approved by the Decision of the Council of the Eurasian Economic Commission on 12 February, 2016 no.28, the Rules for Conducting Research (Tests) to Assess the Biological Effect of Medical Devices, approved by the Decision of the Council of the Eurasian Economic Commission on 16 May, 2016 no. 38, or the Rules for Conducting Clinical and Clinical Laboratory Tests (Studies) of Medical Devices, approved by the Decision of the Council of the Eurasian Economic Commission on 12 February, 2016 no. 29, respectively, as well as the legislation of the member state in the case of conducting tests for the purpose of approving the type of measuring instruments.

12. If necessary, the authorized body (expert organization) involves external experts in the examination if their special knowledge is necessary to conduct the examination.

Representatives of authorized organizations that have conducted tests (studies) in relation to the medical device submitted for examination, specified in subparagraph "b" of paragraph 10 of these Rules, as well as representatives of inspecting organizations that have assessed the quality management system (production inspection) of the manufacturer of such a medical device, cannot be involved in the examination.

When conducting the examination, the expert must be independent of the body or person who appointed the examination, the manufacturer, his authorized representative or other persons interested in the results of the examination.

If the expert is aware of circumstances preventing his involvement in the examination or preventing him from complying with the principles of its conduct, he must inform the head of the authorized body (expert organization) of the reference state about this.

13. The applicant is responsible for the accuracy of the information provided in the registration dossier.

Documents of the registration dossier are submitted in Russian in electronic form. If the legislation of the reference state does not provide for the possibility of issuing these documents in electronic form, the authorized body (expert organization) of the reference state.

In case of providing registration dossier documents on paper, the applicant also provides their electronic copies on an electronic medium (in *.pdf format with a text layer with the ability to select and copy text, as well as to search). Electronic copies of documents must be submitted in accordance with the classifier of document types of the medical device registration dossier, approved by the Decision of the Board of the Eurasian Economic Commission on 3 April, 2018 no. 48.

The operational document or instructions for use of the medical device, the service manual and the text of the medical device labeling are additionally submitted in the state language(s) of the member states, if there are relevant requirements in the legislation of the member states.

Registration dossier documents submitted in a foreign language must be accompanied by a translation into Russian, certified in accordance with the procedure established by the legislation of the reference state.

14. When calculating the term of procedures provided for by these Rules by authorized bodies (expert organizations), the following terms are not taken into account:

a) The period from the date the authorized body (expert organization) of the reference state sends the applicant a request or notification of the need to eliminate identified violations and (or) submit missing documents, or of the need to submit copies of documents on payment for the procedure of agreeing on the expert opinion in the state(s) of recognition, to the date the authorized body (expert organization) of the reference state receives a response to such a request or notification;

b) The term necessary to organize and conduct a production inspection (in case of conducting a production inspection within the procedures for registration and examination);

c) The term necessary to send a report on the results of the production inspection by the inspecting organization (if its role is not performed by the authorized body (expert organization)) to the authorized body (expert organization) for inclusion in the registration dossier (in case of conducting a production inspection within the procedures for registration and examination);

d) The term for agreeing with the applicant on the need to apply to the Advisory Committee on Medical Devices at the Board of the Eurasian Economic Commission (hereinafter referred to as the Advisory Committee).

15. The costs of registration and examination procedures, agreeing on the expert opinion, making changes to the registration dossier (including in a notification procedure), issuing a duplicate of the registration certificate or agreeing on the expert opinion on the registered medical device are borne by the applicant in accordance with the legislation of the member state.

16. Registration is carried out by the reference state based on the results of the examination and agreement of the expert opinion by the state(s) of recognition.

17. Authorized bodies (expert organizations) of the states of recognition have the right to familiarize themselves with the progress of the examination in the reference state and related documents, including documents drawn up when the applicant submits additional and clarifying information in the process of registration and examination of the medical device.

18. Information on medical devices, in respect of which procedures are provided for by these Rules, as well as documents contained in the registration dossier, except for the operational document or instructions for use of the medical device, the service manual, data on labeling and packaging (full-color (with color coding) layouts of packaging and labels), the text of labeling in Russian and state languages of the member states, are confidential information and are available only to interested authorized bodies (expert organizations) of the member states.

19. Inclusion in one registration certificate of several models (brands) of a medical device, including those relating to different types of medical devices in accordance with the nomenclature of medical devices used in the Union, 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 according to one technical documentation;

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

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

d) 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 medical devices for in vitro diagnostics);

e) Models (brands) of the medical device have different configurations that do not affect the principle of operation and functional purpose, which allows to ensure the expansion or specialization of their use for medical purposes (by applicability);

 f) Models (brands) of the medical device have different technical parameters (for example, wavelength of radiation, size of the light field, resolution, etc.) that do not affect the principle of operation and functional purpose (by applicability);

g) Models (brands) of the medical device form a size range (model range) (for example, have different sizes (overall, linear, volumetric, etc.), shape, color coding, are made of the same materials, etc.) or are a group of execution of the medical device (for example, a stationary mobile device (device, system, complex, etc.) with wall and (or) floor mounting, etc.) (by applicability). In this case, a group drawing of parts and/or a group specification are fulfilled in respect of the group of execution of the medical device;

h) Models (brands) of the medical device have the same characteristics in terms of:

• Scope of application;

• Invasiveness;

• Sterility (including taking into account sterilization methods);

• Frequency of use (single use, multiple use by one patient, multiple use by several patients);

• Operational and design features;

• Duration of use;

• Similarity of materials used in modifications of the medical device and in contact with the human body (in terms of their chemical, toxicological, physical, electrical, morphological and mechanical properties).

20. The following are not allowed in the customs territory of the Union:

а) Selection of two or more reference states for registration and examination of one medical device;

 b) Registration of different medical devices under one name;

c) Registration as medical devices of products whose name is contained in the common register of registered medicinal products of the Eurasian Economic Union, the procedure for the formation and maintenance of which is approved by the Decision of the Council of the Eurasian Economic Commission on 3 November, 2016 no. 84, or coincides with the name of a biologically active food supplement, information about which is contained in the common register of certificates of state registration of products, the procedure for the formation and maintenance of which is approved by the Decision of the Board of the Eurasian Economic Commission on 30 June, 2017 n. 80. If a medicinal product or a biologically active food supplement is a component of a medical device, then their names may be used in the name of the medical device.

II. Procedures for Registration and Examination of a Medical Device

21. To register a medical device, the applicant selects a reference state and at least one state of recognition.

22. The applicant submits the following documents to the authorized body (expert organization) of the reference state:

a) A registration dossier containing applications for registration and examination, as well as documents according to the list in Appendix no.4;

b) Copies of documents confirming payment for registration and examination procedures in the reference state.

 

23. The authorized body (expert organization) of the reference state, within 7 working days from the date of receipt of the applications for registration and examination and the documents specified in paragraph 22 of these Rules, verifies the completeness and reliability of the information contained in them.

24. If the applications for registration and examination are submitted in violation of the requirements established by these Rules, or they contain unreliable information, or the documents specified in paragraph 22 of these Rules are not submitted in full, the authorized body (expert organization) of the reference state, within 7 working days from the date of receipt of such applications and documents, notifies the applicant of the need to eliminate the identified violations and (or) submit missing documents within 30 working days from the date of posting the relevant notification in the information system of the authorized body (expert organization) of the reference state or from the date of sending the notification to the applicant in the manner specified in the applications for registration and examination.

25. If, after 30 working days, the applicant has not eliminated the identified violations and (or) has not submitted the missing documents, the authorized body (expert organization) of the reference state, within 3 working days, decides to return the applications for registration and examination and documents to the applicant with justification of the reasons for the return.

26. Within 3 working days from the date of submission of the applications for registration and examination and documents that meet the requirements of these Rules, as well as in the event of elimination within the period specified in paragraph 24 of these Rules of the identified violations and (or) submission of documents that meet the requirements of these Rules, the authorized body (expert organization) of the reference state decides to start the registration and examination procedures, and also places in its information system the registration dossier containing applications for registration and examination.

27. The examination includes (if applicable):

a) Assessment of the correctness of classifying the product as a medical device;

b) Assessment of the conformity of the class of potential risk of application of the medical device indicated by the applicant in accordance with the Rules for Classifying Medical Devices depending on the potential risk of application, approved by the Decision of the Board of the Eurasian Economic Commission on 22 December, 2015 no.173;

c) Assessment of the correctness of classifying the medical device (models (brands) of the medical device) to a certain type of medical devices in accordance with the nomenclature of medical devices, the rules for maintaining which are approved by the Decision of the Board of the Eurasian Economic Commission on 29 December, 2015 no. 177;

d) Assessment of the conformity of models (brands) of the medical device (if any) included in one registration certificate to the criteria established by paragraph 19 of these Rules;

e) Analysis and evaluation of evidentiary documents (materials) confirming the compliance of the medical device with the Common Requirements, including:

• Analysis of the information provided by the manufacturer on the compliance of the medical device with the Common Requirements, including analysis of the correctness of identifying the provisions of the Common Requirements applicable to the medical device;

• Assessment of the conformity of technical test protocols issued by authorized organizations to the Rules for Conducting Technical Tests of Medical Devices;

• Assessment of the conformity of protocols of studies (tests) to assess the biological effect of medical devices issued by authorized organizations to the Rules for Conducting Research (Tests) to Assess the Biological Effect of Medical Devices;

• Analysis of the report on the assessment of the biological effect of the medical device (carried out, inter alia, to confirm that the materials in contact with human tissues are identified (brands of materials and their manufacturers are indicated), as well as to confirm the validity of the absence of the need for studies (tests) to assess the biological effect);

• Analysis of the report on the clinical proof of the effectiveness and safety of the medical device (carried out to confirm the validity of the choice of methods for proving the clinical effectiveness and safety of the medical device, the validity of the data used to prove the clinical effectiveness and safety of the medical device, as well as the validity of the conclusion on clinical effectiveness and safety for all declared indications for use, taking into account the presence or absence of contraindications);

• Assessment of the conformity of reports on clinical (clinical laboratory) tests (studies) of medical devices to the Rules for Conducting Clinical and Clinical Laboratory Tests (Studies) of Medical Devices;

• Analysis of the validity of first-party evidence (if any) to confirm the compliance of the medical device with the Common Requirements, taking into account the class of potential risk of application of the medical device (for medical devices of potential risk classes 2b and 3, the test (study) program and justification of the selected methods must be attached to the first-party evidence);

• Analysis of the standards used by the manufacturer in the design and manufacture of the medical device;

• Analysis of the safety and effectiveness of the medicinal product in the composition of the medical device, its impact on the functionality of the medical device, the compatibility of the medicinal product with the medical device (with the exception of medical devices for in vitro diagnostics). The medicinal product must be registered and authorized for use in the state of manufacture of the medicinal product;

• Analysis of data on the biological safety of the medical device based on the analysis of all materials of animal or human origin included in the medical device, information on the selection of sources (donors), material sampling, processing, storage, testing, validation of testing procedures, as well as the handling of tissues, cells, substances of animal or human origin, cultures of microorganisms and viruses;

• Analysis of the procedure and methods of sterilization of the medical device, materials justifying the method of sterilization, proposed methods of quality control and determination of residues of the sterilizing agent when using the chemical method of sterilization;

• Study of the validity of the software based on the analysis of data on its verification and validation, including information on its development, measures and means of protection against unauthorized access and ensuring cybersecurity, testing by the manufacturer, data on identification and labeling;

• Analysis of the report on the stability of the medical device, the validity of the declared shelf life;

• Consideration of the report on risk analysis in order to confirm the completeness of hazards, hazardous situations, and corresponding risks identified in such report that can be assessed as unacceptable, as well as confirmation of the manufacturer's conclusion about the absence of unacceptable risks or the admissibility of risks that are assessed in the risk analysis report as acceptable based on the analysis of the "risk-benefit" ratio;

• Confirmation, based on the submitted evidentiary materials (documents), of the validity of the manufacturer's assessment result on the compliance of the medical device with the Common Requirements;

• Assessment of the compliance of the operational document or instructions for use, the service manual with the Common Requirements;
• Assessment of the compliance of the medical device labeling with the Common Requirements;

• Analysis of requirements for technical characteristics of the medical device;

• Assessment of documents confirming the results of tests of medical devices for the purpose of approving the type of measuring instruments (in relation to medical devices included in the list of types of medical devices to be classified as measuring instruments);

e) Analysis of reports on the results of the inspection of medical device production (carried out to confirm the compliance of the declared medical device with the group (subgroup) of medical devices, taking into account the class of potential risk of application in accordance with Appendix no.2 to the Requirements for the Quality Management System, as well as to confirm the reliability of information about the production sites specified in the applications for registration and examination, to which the report on the results of the inspection of medical device production applies);
f) Analysis of data on the certification of the quality management system (if any), including requirements for compliance with which the manufacturer's quality management system is certified, and information on certificates (number, date of issue, validity period of the certificate, name and information about the accreditation of the certification body);

g) Confirmation of the validity of the indication of production sites of the registered medical device;

h) Analysis of data on the development and manufacture of the medical device (schemes of production processes, information on the main stages of production, packaging, testing and on the procedure for releasing the final product);

i) Analysis of information on marketing provided by the manufacturer;
j) Analysis of information provided by the manufacturer on the presence or absence of reports of adverse events and/or accidents related to the use of the medical device, recalls from the market of the medical device, medical device safety notifications, approaches to solving such problems by the manufacturer if they arise, a description of the corrective actions taken, as well as an analysis of the ratio of sales levels, the number of accidents and recalls of the medical device from circulation; 

m) Analysis of the plan for collecting data on the safety and effectiveness of the medical device in the post-market phase.

 

28. If, during the examination, the materials and information contained in the applications for registration and examination and the documents of the registration dossier are insufficient to make a decision on the start of production inspection (if it is necessary to conduct it) or to prepare an expert opinion (if there is no need to conduct a production inspection), the authorized body (expert organization) of the reference state sends the applicant a corresponding request (indicating the nature of the comments and ways to eliminate them). The request is sent once in the manner specified in the applications for registration and examination.
    The applicant is obliged to provide a response to the request within 60 working days from the date of its receipt. If the specified response is not provided on time, the authorized body (expert organization) makes a decision on the possibility of registering the medical device based on the documents available to it.

 If the authorized body (expert organization) of the reference state detects unreliable data or documents drawn up or containing text in a foreign language without a translation into Russian certified in the manner prescribed by the legislation of the reference state in the documents submitted by the applicant in response to the request, the authorized body (expert organization), within 2 working days from the date of receipt of such documents, hands over to the applicant, in the manner specified in the applications for registration and examination, a decision to return the specified documents with a justification of the reasons for the return and a message about the possibility of re-submission of documents by the applicant before the expiration of the term specified in the second paragraph of this clause.

 

29. The authorized body (expert organization) of the reference state, within 45 working days from the date of its decision to start the procedures for registration and examination of the medical device, draws up an expert opinion in accordance with Appendix no.5 or, if it is necessary to conduct a production inspection, decides to start conducting a production inspection (provided that there are no comments on the documents contained in the submitted dossier, or the comments specified in the request are eliminated) and notifies the applicant of the decision taken by sending a notification in the manner specified in the applications for registration and examination.

30. When making a decision to start a production inspection by the authorized body (expert organization) of the reference state, the inspecting organization of the reference state conducts a production inspection in accordance with the Requirements for the Quality Management System. The period for organizing and conducting the production inspection should not exceed 90 working days in total from the date the authorized body (expert organization) makes a decision to start the production inspection.

31. The report on the results of the production inspection is sent by the inspecting organization to the authorized body (expert organization) of the reference state for inclusion in the registration dossier and to the applicant by registered mail with notification of delivery or in the form of an electronic document signed with an electronic signature within 15 working days from the date of completion of the production inspection. In this case, if, as a result of the production inspection, non-conformities are identified, the report on the results of the production inspection, supplemented with information on the elimination of the identified non-conformities, is sent by the inspecting organization to the authorized body (expert organization) of the reference state within 15 working days after receiving information from the applicant on the elimination of non-conformities or from the date of expiration of the period established for their elimination.

In case, as a result of the production inspection, changes are made to the registration dossier documents for the registered medical device, such documents, drawn up in accordance with Appendix N 4, are sent by the inspecting organization to the authorized body (expert organization) of the reference state.

32. The authorized body (expert organization) of the reference state, within 15 working days from the date of receipt of the report on the results of the production inspection, draws up an expert opinion in accordance with Appendix no.5 to these Rules.

33. The conclusions contained in the expert opinion must be unambiguous and understandable.

34. The grounds for the authorized body (expert organization) of the reference state to issue a conclusion on the refusal to register a medical device are:

a) Non-confirmation by relevant materials and information contained in the registration dossier of the quality, and/or effectiveness, and/or safety of the medical device;

 b) Exceeding the risk of harm to the health of citizens and medical workers as a result of the use of the medical device over the effectiveness of its use;

c) Detection during the implementation by authorized bodies of state control (supervision) over the circulation of medical devices of unreliable data on the effectiveness and safety of the medical device and their inconsistency with the data on the medical device contained in the registration dossier documents.

35. If the expert opinion on the possibility of registering a medical device is negative, the authorized body (expert organization), within 10 working days from the date of drawing up (receiving) the expert opinion, decides to refuse to register the medical device, draws up and issues to the applicant in the manner specified in the applications for registration and examination, a notification of refusal to register the medical device with justification of the reasons for the refusal and attaching a copy of the expert opinion of the authorized body (expert organization) of the reference state to it.

36. If the expert opinion on the possibility of registering a medical device is positive, the authorized body (expert organization) of the reference state, within 5 working days from the date of drawing up the expert opinion, places the registration dossier and this expert opinion in its information system and notifies the applicant of the need to submit copies of documents on payment for the procedure of agreeing on the expert opinion in the state(s) of recognition within 30 calendar days from the date of sending such notification to the applicant in the manner specified in the applications for registration and examination.
37. The applicant notifies the authorized bodies (expert organizations) of the reference state and the state(s) of recognition of the payment for the agreement procedures within the period established by paragraph 36 of these Rules.

38. Agreement on the expert opinion is the basis for making a decision on the registration of a medical device in the state of recognition and is drawn up by the authorized body (expert organization) of the state of recognition in the form of a conclusion on confirming agreement (disagreement) on the expert opinion in accordance with Appendix no.6 (hereinafter referred to as confirmation of agreement (disagreement) on the expert opinion).

39. Agreement on the expert opinion by the authorized body (expert organization) of the state of recognition is carried out in accordance with Section III of these Rules.

40. Provided that there are no disagreements between the reference state and the state(s) of recognition regarding the agreement on the expert opinion, the authorized body (expert organization) of the reference state:
      a) Within 10 working days from the date of receipt from all authorized bodies (expert organizations) of the states of recognition of confirmation of agreement on the expert opinion or from the date of expiration of the period established for the provision by the states of recognition of the specified confirmation (provided that the applicant has submitted to the authorized body (expert organization) of the reference state copies of documents on payment for the procedure of agreeing on the expert opinion in the states of recognition and translations of the operational document or instructions for use of the medical device, the service manual and the text of labeling into the state languages of the states of recognition (if necessary)), makes a decision on the registration of the medical device and places in the common register of medical devices registered within the Union, information on the medical device provided for by the Procedure for the formation and maintenance of the information system;

b) Within 10 working days from the date of making the decision on the registration of the medical device, draws up and issues to the applicant in the manner specified in the application for the registration of the medical device, a registration certificate and an appendix to it.

 

41. Disagreement on the expert opinion of the authorized body (expert organization) of the reference state in one of the states of recognition is the basis for refusing to register the medical device in the territory of this state of recognition.

42. In the event that there is a state (states) of recognition, the expert opinion of whose authorized body (expert organization) is not agreed upon, the authorized body (expert organization) of the reference state, within 10 working days from the date of receipt from all authorized bodies (expert organizations) of the states of recognition of confirmation of agreement (disagreement) on the expert opinion or from the date of expiration of the period established for the provision by the states of recognition of the specified confirmation (provided that the applicant has submitted to the authorized body (expert organization) of the reference state copies of documents on payment for the procedure of agreeing on the expert opinion in the states of recognition and translations of the operational document or instructions for use of the medical device, the service manual and the text of labeling into the state languages of the states of recognition (if necessary)), taking into account the nature of the identified comments, performs one of the following actions:
a) Sends the applicant a notification of the need to agree on an appeal to the Advisory Committee to resolve disagreements regarding the agreement of the expert opinion, with a copy (copies) of the confirmation of agreement (disagreement) on the expert opinion attached. In the absence of a response from the applicant after 15 working days from the date of receipt of the corresponding notification, the appeal to the Advisory Committee is considered uncoordinated;

b) In case of agreement with the conclusions of the authorized body (expert organization) of the state of recognition on the impossibility of registering the medical device, makes a decision to refuse to register the medical device. In this case, the authorized body (expert organization) of the reference state, within 10 working days from the date of making the decision to refuse to register the medical device, draws up and issues to the applicant in the manner specified in the applications for registration and examination, a notification of refusal to register the medical device (with justification of the reasons for the refusal and attaching copies of the expert opinion and confirmation of disagreement on the expert opinion to it).

 

43. The authorized body (expert organization) of the reference state, within 3 working days from the date of receipt of the response from the applicant regarding the appeal to the Advisory Committee to resolve disagreements regarding the expert opinion:

a) Appeals to the Advisory Committee in accordance with Section IV of these Rules (in case of agreement by the applicant to appeal to the Advisory Committee);

b) Makes a decision on the registration of the medical device without specifying in the registration certificate the state(s) of recognition whose authorized body (expert organization) has not agreed on the expert opinion (in case of disagreement by the applicant to appeal to the Advisory Committee). In this case, the authorized body (expert organization) of the reference state, within 10 working days from the date of making the decision on the registration of the medical device:

• Places in the common register of medical devices registered within the Union, information on the medical device provided for by the Procedure for the formation and maintenance of the information system;

• Draws up and issues to the applicant in the manner specified in the application for the registration of the medical device, a registration certificate and an appendix to it.

 

III. Procedure for agreeing on the expert opinion
44. The procedure for agreeing on the expert opinion is carried out in relation to the expert opinion drawn up within the framework of the following procedures:

a) The procedure for registration and examination of the medical device in accordance with Section II of these Rules;

b) The procedure for making changes to the registration dossier in accordance with Section V of these Rules;

c) The procedure for agreeing on the expert opinion on the registered medical device in accordance with Section VIII of these Rules.

 

45. The applicant, within a period agreed with the authorized body (expert organization) of the state of recognition and not exceeding the period specified in paragraph 50 of these Rules, ensures the submission to the authorized body (expert organization) of the reference state and the state of recognition of translations of the operational document or instructions for use of the medical device, the service manual and the text of labeling into the state language of the state of recognition (if there are relevant requirements in the legislation of the state of recognition).

46. When carrying out the procedure for agreeing on the expert opinion, the authorized body (expert organization) of the state of recognition assesses the completeness and sufficiency of data confirming the safety, quality and effectiveness of the medical device, the correctness of the translation of the operational document or instructions for use of the medical device, the service manual and the text of labeling into the state language of the state of recognition (if necessary).

47. If necessary, the authorized bodies (expert organizations) of the states of recognition can send their comments and suggestions to the authorized body (expert organization) of the reference state using the means of the integrated information system of the Union (hereinafter referred to as the integrated system) before this authorized body (expert organization) 

48. In the course of agreeing on the expert opinion, authorized bodies (expert organizations) of the member states may interact with each other in order to resolve emerging issues.

49. In the event of disagreements between the reference state and the state(s) of recognition regarding the agreement on the expert opinion, the authorized body (expert organization) of the reference state makes a decision based on the expert opinion and confirmation of disagreement on the expert opinion, including taking into account the results of resolving disagreements regarding the agreement on the expert opinion within the framework of the Advisory Committee (in case of appeal to the Advisory Committee).
50. The authorized body (expert organization) of the state of recognition considers the expert opinion within 30 working days, calculated from one of the following dates:

  • When carrying out the procedures for registration and examination of the medical device - from the date of receipt by the authorized bodies (expert organizations) of the reference state and the state(s) of recognition of notification of payment for the agreement procedures;

• When carrying out the procedure for making changes to the registration dossier - from the date the authorized body (expert organization) of the reference state places in its information system the registration dossier containing the application for making changes to the registration dossier;

 • When carrying out the procedure for agreeing on the expert opinion on the registered medical device - from the date the authorized body (expert organization) of the reference state places in its information system the registration dossier containing the application for carrying out the agreement on the expert opinion on the registered medical device.

 In this case, the condition for calculating the specified term is the availability in the account of the authorized body (expert organization) of the state of recognition of funds received as a result of payment by the applicant for the procedure of agreeing on the expert opinion in the state of recognition in full.

 

51. Based on the results of consideration of the expert opinion, the authorized body (expert organization) of the state of recognition sends to the authorized body (expert organization) of the reference state a confirmation of agreement (disagreement) on the expert opinion (with justification) using the means of the integrated system (including confirmation of the correctness of the translation of the operational document or instructions for use of the medical device, the service manual and the text of labeling into the state languages of the states of recognition in accordance with the legislation of the member states).

52. In the event that the state of recognition does not provide confirmation of agreement (disagreement) on the expert opinion within the period established by paragraph 50 of these Rules, the expert opinion is considered agreed upon, provided that the applicant has submitted to the authorized bodies (expert organizations) of the reference state and the state of recognition translations of the operational document or instructions for use of the medical device, the service manual and the text of labeling into the state language of the state of recognition (if there are relevant requirements in the legislation of the state of recognition).

53. Within the framework of the procedures for registration and examination of the medical device in accordance with Section II of these Rules, the grounds for disagreement by the state of recognition with the expert opinion are:

a) The grounds provided for in paragraph 34 of these Rules;

b) Failure by the applicant to submit within the agreed period a translation of the operational document or instructions for use of the medical device, the service manual and the text of labeling into the state language of the state of recognition (if necessary);

c) The absence in the account of the authorized body (expert organization) of the state of recognition of funds received as a result of payment by the applicant for the procedure of agreeing on the expert opinion in full.

 

54. Within the framework of the procedure for agreeing on the expert opinion on the registered medical device in accordance with Section VIII of these Rules, the grounds for disagreement by the state of recognition with the expert opinion are the grounds provided for in paragraph 34 of these Rules.

55. Within the framework of the procedure for making changes to the registration dossier in accordance with Section V of these Rules, the grounds for disagreement by the state of recognition with the expert opinion are:

a) The grounds provided for in paragraph 79 of these Rules;

b) The absence of translations of the operational document or instructions for use of the medical device, the service manual and the text of labeling into the state language of the state of recognition (if necessary).

 

IV. Resolution of Disagreements Regarding the Agreement of the Expert Opinion

56. In the absence of consensus on the issue of agreeing on the expert opinion, drawn up within the framework of the procedures for registration and examination of the medical device in accordance with Section II of these Rules, the resolution of disagreements is carried out by the authorized body (expert organization) of the reference state appealing to the Advisory Committee.

57. The authorized body (expert organization) of the reference state, in coordination with the applicant, sends to the Advisory Committee a statement on the need to consider the disagreements (indicating information on the subject of the disagreements and on the results of the negotiations and consultations held). Any materials justifying the position of the authorized body (expert organization) of the reference state on the subject of the disagreements may be attached to the statement.

58. After receiving the statement and the materials attached to it from the authorized body (expert organization) of the reference state, the Advisory Committee requests from the authorized bodies (expert organizations) of the states of recognition materials confirming their position on the subject of the disagreements.

59. The Advisory Committee sends a notification of the meeting to resolve disagreements to the authorized bodies (expert organizations) of the reference state and the states of recognition after they submit the relevant materials.

60. The organization and holding of the meeting to resolve disagreements is provided by the Advisory Committee. The meeting is attended by members of the Advisory Committee who are representatives of authorized bodies (expert organizations). If necessary, at the suggestion of authorized bodies, representatives of healthcare organizations, expert organizations, the manufacturer and other specialists may be invited to participate in the consideration of the issue being discussed at the Advisory Committee meeting.

61. Based on the results of the Advisory Committee meeting, a decision is made, which is of an advisory nature.

62. The period for resolving disagreements regarding the agreement of the expert opinion should not exceed 30 working days from the date the authorized body (expert organization) of the reference state sends the relevant statement and materials to the Advisory Committee.

63. Within 3 working days from the date of receipt of the minutes of the Advisory Committee meeting on the resolution of disagreements, the authorized body (expert organization) of the reference state, based on the recommendations of the Advisory Committee, makes a decision regarding the possibility of registering the medical device.

64. If the decision made in accordance with paragraph 63 of these Rules is positive, the authorized body (expert organization) of the reference state, within 3 working days from the date of its adoption:

a) Places in the common register of medical devices registered within the Union, information on the medical device provided for by the Procedure for the formation and maintenance of the information system;

b) Draws up a registration certificate and an appendix to it (indicating the states of recognition whose authorized bodies (expert organizations) have agreed on the expert opinion) and issues them to the applicant in the manner specified in the application for registration of the medical device;

c) If, based on the results of the Advisory Committee meeting, there is a state (states) of recognition whose authorized body (expert organization) has not agreed on the expert opinion, sends to the applicant in the manner specified in the applications for registration and examination, a notification of the decision taken by the authorized body (expert organization) of the state of recognition (with a copy of the confirmation of disagreement on the expert opinion and the decision (protocol record) of the Advisory Committee attached).

 

65. If the decision made in accordance with paragraph 63 of these Rules is negative, the authorized body (expert organization) of the reference state, within 3 working days from the date of its adoption, draws up and issues to the applicant in the manner specified in the applications for registration and examination, a notification of refusal to register the medical device (with justification of the reasons for the refusal and attaching copies of the expert opinion, confirmation of disagreement on the expert opinion and the decision (protocol record) of the Advisory Committee).

V. Procedure for making changes to the registration dossier
66. The applicant, within 90 calendar days from the date of making changes to the documents contained in the registration dossier, is obliged to initiate the procedure for making such changes to the registration dossier.
67. The changes to the registration dossier requiring the registration of a new medical device include:

a) Changes entailing a change in 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 for inclusion in one registration certificate of several models (brands) of the medical device in accordance with paragraph 19 of these Rules;

c) Changes entailing a simultaneous change in information about the manufacturer and the production site(s) in relation to the information specified in the registration certificate issued within the framework of the procedures for registration and examination of the medical device, with the exception of information about the organizational and legal form, address, reorganization, other information contained in the constituent documents.

68. In the event of changes entailing a change in the operational document or instructions for use of the medical device, the service manual and the text of labeling, within 180 calendar days from the date of making these changes, the release into circulation of medical devices corresponding to the documents and information from the registration dossier before the changes are made is allowed. The simultaneous release into circulation of medical devices with an operational document or instructions for use of the medical device, a service manual and a text of labeling corresponding to the documents and information from the registration dossier before and after the changes are made is allowed.

69. The procedure for making changes to the registration dossier (with the exception of changes for which the procedure for making them in a notification procedure is provided) requires carrying out the procedure for agreeing on the expert opinion with the states of recognition specified in the registration certificate, in accordance with the procedure established by Section III of these Rules.

70. In order to make changes to the registration dossier, the applicant sends the following documents and information to the authorized body (expert organization) of the reference state:

a) An application for making changes to the registration dossier (on paper and (or) in electronic form) in the form according to Appendix no.7 (hereinafter in this section - the application for making changes);

b) A copy of a document confirming the powers of the authorized representative of the manufacturer (if any);

c) Documents and information on the corresponding changes, including documents confirming the changes and indicating that the introduction of these changes does not entail changes in the properties and characteristics of the medical device affecting its safety, quality and effectiveness, or improves its properties and characteristics while maintaining the functional purpose and/or principle of operation of the medical device;

d) Copies of documents confirming payment for the procedure of making changes to the registration dossier in the reference state and the procedure of agreeing on the expert opinion in the state(s) of recognition, as well as issuing a registration certificate in the reference state (if necessary);

e) The original registration certificate (duplicate);

f) A list of documents.

 

71. The authorized body (expert organization) of the reference state, within 7 working days from the date of receipt of the application for making changes, as well as the documents and information specified in paragraph 70 of these Rules, verifies the completeness and reliability of the information contained in them.

72. If the application for making changes is submitted in violation of the requirements of these Rules and/or contains unreliable information and/or the documents and information specified in paragraph 70 of these Rules are not submitted in full, the authorized body (expert organization) of the reference state, within 7 working days from the date of receipt of such application, documents and information, notifies the applicant of the need to eliminate the identified violations and/or submit missing documents within 30 working days from the date of posting the relevant notification in the information system of the authorized body (expert organization) of the reference state or from the date of sending the notification to the applicant in the manner specified in the application for making changes.

73. If, after 30 working days, the applicant has not eliminated the identified violations and/or has not submitted the missing documents, the authorized body (expert organization) of the reference state, within 3 working days, decides to return the application for making changes and documents (with justification of the reasons for the return).

74. Within 3 working days from the date of submission of the application for making changes, documents and information that meet the requirements of these Rules, as well as in the event of elimination within a 30-day period of the identified violations and/or submission of documents that meet the requirements of these Rules, the authorized body (expert organization) of the reference state makes a decision to start the procedure for making changes to the registration dossier and places in its information system the registration dossier containing the application for making changes and documents confirming the changes.

75. If, during the examination, the materials and information contained in the application for making changes and documents confirming the changes are insufficient, the authorized body (expert organization) of the reference state sends the applicant a corresponding request (indicating comments and ways to eliminate them). The request is sent to the applicant once in the manner specified in the application for making changes.

The applicant submits a response to the request within 60 working days from the date of its receipt. If a response is not provided within the specified period, the authorized body (expert organization) of the reference state makes a decision based on the documents available to it.

76. If the authorized body (expert organization) of the reference state detects unreliable information or documents drawn up or containing text in a foreign language without a translation into Russian certified in the manner prescribed by the legislation of the member state in the documents submitted by the applicant in response to the request, the authorized body (expert organization) of the reference state, within 2 working days from the date of receipt of such documents, hands over to the applicant in the manner specified in the application for making changes, a decision to return the specified documents (with justification of the reasons for the return and a message about the possibility of re-submission of documents before the expiration of the period specified in the second paragraph of paragraph 75 of these Rules).

77. The authorized body (expert organization) of the reference state conducts an examination and draws up an expert opinion in accordance with Appendix no. 8 within 30 working days from the date of making a decision to start the procedure for making changes to the registration dossier.

78. The conclusions contained in the expert opinion must be unambiguous and understandable.

79. The grounds for the authorized body (expert organization) of the reference state to prepare an expert opinion on the impossibility of making changes to the registration dossier are:

a) Unreliability of the submitted information justifying the introduction of changes (including that identified during the implementation by authorized bodies of state control (supervision) over the circulation of medical devices);

b) The absence in the documents submitted by the applicant of information confirming that the changes made to the documents contained in the registration dossier do not entail changes in the properties and characteristics of the medical device affecting its safety, quality and effectiveness, or improve the properties and characteristics while maintaining the functional purpose and/or principle of operation of the medical device;

c) The need to conduct a new registration of the medical device in accordance with paragraph 67 of these Rules.

 

80. The authorized body (expert organization) of the reference state, within 10 working days from the date of drawing up (receiving) the expert opinion on the impossibility of making changes to the registration dossier, makes a decision to refuse to make these changes, draws up and issues to the applicant in the manner specified in the application for making changes, a notification of refusal to make changes to the registration dossier (with justification of the reasons for the refusal and attaching a copy of the expert opinion of the authorized body (expert organization) of the reference state and the original (duplicate) of the registration certificate.

81. After drawing up in the reference state an expert opinion on the possibility of making changes to the registration dossier, the authorized body (expert organization) of the reference state places in its information system the registration dossier containing the application for making changes and the expert opinion.

82. In the absence of a state (states) of recognition, the authorized body (expert organization) of the reference state, within 10 working days from the date of drawing up the expert opinion on the possibility of making changes to the registration dossier:

a) Makes a decision to make changes to the registration dossier and places in the common register of medical devices registered within the Union, information on making changes to the registration dossier in accordance with the Procedure for the formation and maintenance of the information system, as well as scanned copies of documents in which changes have been made;

b) Within 10 working days from the date of making the decision to make changes to the registration dossier, notifies the applicant of this in the manner specified in the application for making changes, as well as in the event of making changes to the registration certificate and/or the appendix to it, draws up and issues to the applicant in the manner specified in the application for making changes, reissued registration certificate and appendix to it with the same number (indicating the date of making the corresponding changes) and returns the previously issued registration certificate and appendix to it with a note about their invalidity (indicating the date).

 

83. In the event that there is a state (states) of recognition and provided that there are no disagreements between the authorized body (expert organization) of the reference state and the authorized body (expert organization) of the state (states) of recognition regarding the agreement on the expert opinion, the authorized body (expert organization) of the reference state:

a) Within 10 working days from the date of receipt from the authorized bodies (expert organizations) of all states of recognition of confirmation of agreement on the expert opinion or from the date of expiration of the period provided for in paragraph 50 of these Rules (provided that the applicant has submitted to the authorized body (expert organization) of the reference state a translation of the operational document or instructions for use of the medical device, the service manual and the text of labeling into the state languages of the states of recognition (if necessary)), makes a decision to make changes to the registration dossier and places in the common register of medical devices registered within the Union, information on making changes to the registration dossier in accordance with the Procedure for the formation and maintenance of the information system, as well as scanned copies of documents in which changes have been made;

b) Within 10 working days from the date of making the decision to make changes to the registration dossier, notifies the applicant of this in the manner specified in the application for making changes, as well as in the event of making changes to the registration certificate and/or the appendix to it, draws up and issues to the applicant in the manner specified in the application for making changes, reissued registration certificate and appendix to it with the same number (indicating the date of making the corresponding changes) and returns the previously issued registration certificate and appendix to it with a note about their invalidity (indicating the date).

 

84. Disagreement on the expert opinion of the authorized body (expert organization) of the reference state in one of the states of recognition is the basis for excluding information about this state from the registration certificate.

85. If the authorized body (expert organization) of the state of recognition has not agreed on the expert opinion and the authorized body (expert organization) of the reference state agrees with the conclusions of the authorized body (expert organization) of the state of recognition regarding the impossibility of making changes to the registration dossier, the authorized body (expert organization) of the reference state:

a) Within 10 working days from the date of receipt from the authorized bodies (expert organizations) of all states of recognition of confirmation of agreement (disagreement) on the expert opinion or from the date of expiration of the period provided for in paragraph 50 of these Rules, makes a decision to refuse to make changes to the registration dossier; 

b) Within 10 working days from the date of making the decision to refuse to make changes to the registration dossier, draws up and issues to the applicant in the manner specified in the application for making changes, a notification of refusal to make changes to the registration dossier (with justification of the reasons for the refusal, as well as with a copy of the expert opinion of the authorized body (expert organization) of the reference state, a copy (copies) of the confirmation of agreement (disagreement) on the expert opinion and the original (duplicate) of the registration certificate attached).

 

86. If the authorized body (expert organization) of the state of recognition has not agreed on the expert opinion and the authorized body (expert organization) of the reference state does not agree with the conclusions of the authorized body (expert organization) of the state of recognition regarding the impossibility of making changes to the registration dossier, the authorized body (expert organization) of the reference state:

a) Within 10 working days from the date of receipt from the authorized bodies (expert organizations) of all states of recognition of confirmation of agreement (disagreement) on the expert opinion or from the date of expiration of the period established for the provision by the states of recognition of the specified confirmation (provided that the applicant has submitted to the authorized body (expert organization) of the reference state a translation of the operational document or instructions for use of the medical device, the service manual and the text of labeling into the state languages of the states of recognition (if necessary)):

• Makes a decision to make changes to the registration dossier and to exclude from the registration certificate information about the state (states) of recognition whose authorized body (expert organization) has not agreed on the expert opinion;

• Places in the common register of medical devices registered within the Union, information on making changes to the registration dossier in accordance with the Procedure for the formation and maintenance of the information system, as well as scanned copies of documents in which changes have been made;

 

b) Within 10 working days from the date of making the decision to make changes to the registration dossier:

• Notifies the applicant of making changes to the registration dossier and of excluding from the registration certificate information about the state (states) of recognition whose authorized body (expert organization) has not agreed on the expert opinion, in the manner specified in the application for making changes (with a copy of the confirmation of disagreement on the expert opinion attached);

• Draws up and issues to the applicant in the manner specified in the application for making changes, reissued registration certificate and appendix to it, from which information about the state (states) of recognition whose authorized body (expert organization) has not agreed on the expert opinion is excluded, and in which changes have been made in accordance with the application for making changes, with the same number (indicating the date of making the corresponding changes);

• Returns to the applicant in the manner specified in the application for making changes, the previously issued registration certificate and appendix to it with a note about their invalidity (indicating the date).

 

VI. Procedure for making changes to the registration dossier in a notification procedure

87. The procedure for making changes to the registration dossier in a notification procedure is applied in the following cases:

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

b) Changes are made by the manufacturer of medical devices of potential risk class 1 or non-sterile medical devices of potential risk class 2a, who have undergone an assessment of the quality management system of the medical device (including the processes of design and development of medical devices) in accordance with the Requirements for the Quality Management System;

c) Changes concern the following information about the manufacturer of the medical device or its authorized representative:

• Name of the legal entity (full and abbreviated (if any), including trade names), address of the location or address of the place of business;

• Last name, first name, patronymic (if any), address of residence of the individual entrepreneur or address of the place of business and details of the identity document;

d) Changes to the name of the medical device in terms of the trademark and other means of individualization;

e) Changes consist in excluding information about the model (brand) of the medical device from the registration certificate.

 

88. In order to make changes to the registration dossier in a notification procedure, the applicant sends the following documents and information to the authorized body (expert organization) of the reference state:

a) An application for making changes to the registration dossier in a notification procedure (on paper and (or) in electronic form) in the form according to Appendix no.9 (hereinafter in this section - the application for making changes);

b) A copy of a document confirming the powers of the authorized representative of the manufacturer (if the manufacturer has an authorized representative);

c) Documents and information on the corresponding changes, including documents confirming the changes and indicating that the introduction of these changes does not entail changes in the properties and characteristics of the medical device affecting its safety, quality and effectiveness, or improves its properties and characteristics while maintaining the functional purpose and/or principle of operation of the medical device;

d) Reports on the results of the initial, periodic (scheduled) and unscheduled production inspections (in the case provided for in subparagraph "b" of paragraph 87 of these Rules);

e) Copies of documents confirming payment for the procedure of making changes to the registration dossier in a notification procedure in the reference state, as well as issuing a registration certificate in the reference state (if necessary);

f) The original registration certificate (duplicate) (if it is necessary to make changes to it);

g) A list of documents.

 

89. The application for making changes and documents confirming the changes (including reports on the results of production inspections) are placed by the authorized body (expert organization) of the reference state in its information system with access granted only to the authorized bodies (expert organizations) of the reference state and the state(s) of recognition.

90. The authorized body (expert organization) of the reference state, within 7 working days from the date of receipt of the application for making changes, as well as the documents and information specified in paragraph 88 of these Rules, verifies the completeness and reliability of the information contained in them (including the validity period of the reports on the results of production inspections).

91. If the application for making changes is submitted in violation of the requirements of these Rules, contains unreliable information and/or the documents and information specified in paragraph 88 of these Rules are not submitted in full, the authorized body (expert organization) of the reference state, within 7 working days from the date of receipt of such application, documents and information, notifies the applicant of the need to eliminate the identified violations and/or submit missing documents within 30 working days from the date of posting the relevant notification in the information system of the authorized body (expert organization) of the reference state or from the date of sending the notification to the applicant in the manner specified in the application for making changes.

92. If, after 30 working days, the applicant has not eliminated the identified violations and/or has not submitted the missing documents, the authorized body (expert organization) of the reference state, within 3 working days, makes a decision to return the application for making changes and documents (with justification of the reasons for the return).

93. Within 3 working days from the date of submission of the application for making changes, documents and information that meet the requirements of these Rules, as well as in the event of elimination within the period established by paragraph 91 of these Rules of the identified violations and/or submission of documents that meet the requirements of these Rules, the authorized body (expert organization) of the reference state makes a decision to start the procedure for making changes to the registration dossier in a notification procedure and places in its information system the registration dossier containing the application for making changes.

94. If the validity period of the report on the results of the production inspection has expired (for the case provided for in subparagraph "b" of paragraph 87 of these Rules), the application for making changes is not accepted and changes to the registration dossier are made in accordance with the procedure provided for in Section V of these Rules.

95. Making changes to the registration dossier in a notification procedure is carried out by the authorized body (expert organization) of the reference state within 15 working days from the date of making a decision to start the procedure for making changes to the registration dossier in a notification procedure.

96. The procedure for making changes to the registration dossier in a notification procedure does not require agreement with the states of recognition. In this regard, the states of recognition are not indicated in the application for making changes.

97. If the changes being made concern information contained in the registration certificate, the authorized body of the reference state issues a new registration certificate with the same number (indicating the date of making the corresponding changes).

98. The grounds for the authorized body (expert organization) of the reference state to make a decision to refuse to make changes to the registration dossier in a notification procedure are:

a) Unreliability of the submitted information justifying the introduction of changes in a notification procedure (including the expiration of the report on the results of the production inspection);

b) Non-compliance of the submitted documents and information with paragraph 88 of these Rules;

c) The need to conduct a new registration of the medical device in accordance with paragraph 67 of these Rules;

d) Non-compliance of the changes being made with the cases specified in paragraph 87 of these Rules.

 

99. The authorized body (expert organization) of the reference state, within 5 working days from the date of making a decision to refuse to make changes to the registration dossier in a notification procedure, draws up and issues to the applicant in the manner specified in the application for making changes, a notification of refusal to make changes to the registration dossier in a notification procedure with justification, and also returns to the applicant in the manner specified in the application for making changes, the previously issued registration certificate (duplicate) and the appendix to it, if they were provided.

100. The authorized body of the reference state, within 5 working days from the date of making a decision to make changes to the registration dossier in a notification procedure:

a) Places in the common register of medical devices registered within the Union, information on making changes to the registration dossier in accordance with the Procedure for the formation and maintenance of the information system, as well as scanned copies of documents in which changes have been made;

b) Draws up and issues to the applicant in the manner specified in the application for making changes, a notification of making changes to the registration dossier in a notification procedure, as well as, if necessary, reissued registration certificate and appendix to it with the same number (indicating the date of making the corresponding changes);

c) Returns to the applicant in the manner specified in the application for making changes, the previously issued registration certificate (duplicate) and the appendix to it with a note about their invalidity (indicating the date), if they were provided.

 

VII. Procedure for issuing a duplicate registration certificate

101. In case of loss (damage) of the registration certificate, the applicant has the right to apply to the authorized body of the reference state with an application for issuing a duplicate registration certificate (on paper and (or) in electronic form) in the form according to Appendix no. 10.

102. In case of damage to the registration certificate, the damaged registration certificate is attached to the application for issuing a duplicate registration certificate.

103. Within 5 working days from the date of receipt of the application for issuing a duplicate registration certificate, the authorized body of the reference state draws up a duplicate registration certificate on the form and issues it to the applicant in the manner specified in the application for issuing a duplicate registration certificate.

104. If the submitted application for issuing a duplicate registration certificate is drawn up improperly and/or contains unreliable information, the authorized body of the reference state draws up a decision to refuse to issue a duplicate registration certificate.
VIII. Procedure for agreeing on the expert opinion on the registered medical device

105. The procedure for registering a medical device registered in accordance with these Rules in member states not specified in the registration certificate is carried out by agreement of the authorized bodies (expert organizations) of these member states on the expert opinion. Based on the results of the agreement, the authorized body of the reference state issues a registration certificate indicating all states of recognition whose authorized bodies (expert organizations) have agreed on the expert opinion.

106. The applicant submits the following documents (copies of documents) to the authorized body (expert organization) of the reference state:

a) A registration dossier containing an application for carrying out the agreement on the expert opinion on the registered medical device (indicating the state(s) of recognition not specified in the registration certificate) (on paper and (or) in electronic form) in the form according to Appendix no.11 (hereinafter in this section - the application for agreeing on the expert opinion) and documents according to the list in Appendix no.12;

b) Copies of documents on payment for issuing a new registration certificate in the reference state (if there are relevant requirements);

c) Copies of documents on payment for the procedure of agreeing on the expert opinion in the state(s) of recognition specified in the application for agreeing on the expert opinion.

107. The authorized body (expert organization) of the reference state, within 7 working days from the date of receipt of the application for agreeing on the expert opinion and the documents specified in paragraph 106 of these Rules, verifies the completeness and reliability of the information contained in them.

108. If the application for agreeing on the expert opinion is submitted in violation of the requirements of these Rules, contains unreliable information and/or the documents specified in paragraph 106 of these Rules are not submitted in full, the authorized body (expert organization) of the reference state, within 7 working days from the date of receipt of such application and documents, notifies the applicant of the need to eliminate the identified violations and/or submit missing documents within 30 working days from the date of posting the relevant notification in the information system of the authorized body (expert organization) of the reference state or from the date of sending the notification to the applicant in the manner specified in the application for agreeing on the expert opinion.

109. If, after 30 working days, the applicant has not eliminated the identified violations and/or has not submitted the missing documents, the authorized body (expert organization) of the reference state, within 3 working days, makes a decision to return the application for agreeing on the expert opinion and documents (with justification of the reasons for the return).

110. Within 3 working days from the date of submission of the application for agreeing on the expert opinion and documents that meet the requirements of these Rules, as well as in the event of elimination within the period established by paragraph 108 of these Rules of the identified violations and/or submission of documents that meet the requirements of these Rules, the authorized body (expert organization) of the reference state makes a decision to carry out the procedure for agreeing on the expert opinion on the registered medical device and places in its information system the registration dossier containing the application for agreeing on the expert opinion.

111. Agreement on the expert opinion by the states of recognition specified in the application for agreeing on the expert opinion is carried out in accordance with paragraphs 46, 48 - 52 and 54 of these Rules.

112. Disagreement on the expert opinion in one of the states of recognition specified in the application for agreeing on the expert opinion is the basis for refusing the circulation of the medical device in the territory of this state of recognition.

113. Within 10 working days from the date of receipt from all authorized bodies (expert organizations) of the states of recognition specified in the application for agreeing on the expert opinion of confirmation of agreement (disagreement) on the expert opinion or from the date of expiration of the period established by paragraph 50 of these Rules, the authorized body (expert organization) of the reference state makes a decision on issuing a reissued registration certificate (if there are states of recognition whose authorized bodies (expert organizations) have agreed on the expert opinion) or on refusing to issue a reissued registration certificate (if there are no states of recognition whose authorized bodies (expert organizations) have agreed on the expert opinion).

Within 10 working days from the date of making a decision on issuing a reissued registration certificate, the authorized body (expert organization) of the reference state:

• Places in the common register of medical devices registered within the Union, information on the states of recognition specified in the application for agreeing on the expert opinion, whose authorized bodies (expert organizations) have agreed on the expert opinion, as well as scanned copies of documents in which changes have been made, in accordance with the Procedure for the formation and maintenance of the information system;

• Draws up and issues to the applicant in the manner specified in the application for agreeing on the expert opinion, a reissued registration certificate and an appendix to it with the same number (indicating all states of recognition whose authorized bodies (expert organizations) have agreed on the expert opinion and the date of making the corresponding changes);

• Returns to the applicant in the manner specified in the application for agreeing on the expert opinion, the previously issued registration certificate (duplicate) and the appendix to it with a note about their invalidity (indicating the date);

• Issues to the applicant in the manner specified in the application for agreeing on the expert opinion, a notification of refusal to register the medical device by the state of recognition specified in the application for agreeing on the expert opinion, with a copy of the confirmation of disagreement on the expert opinion by the authorized body (expert organization) of the specified state attached (if there is a state of recognition whose authorized body (expert organization) has not agreed on the expert opinion).

Within 10 working days from the date of making a decision on refusing to issue a reissued registration certificate, the authorized body (expert organization) of the reference state:

• Returns to the applicant in the manner specified in the application for agreeing on the expert opinion, the previously issued registration certificate (duplicate) and the appendix to it;

• Issues to the applicant in the manner specified in the application for agreeing on the expert opinion, a notification of refusal to register the medical device by the state of recognition specified in the application for agreeing on the expert opinion, with a copy of the confirmation of disagreement on the expert opinion by the authorized body (expert organization) of the specified state, as well as the original (duplicate) of the registration certificate attached.

 

IX. Procedure for suspending or revoking (canceling) a registration certificate

114. Suspension of the registration certificate is carried out by the authorized body of the reference state in the following cases:

a) Based on the results of monitoring the safety, quality and effectiveness of medical devices in the post-registration period - when a potential serious threat to human health is detected;

b) Based on the results of state control (supervision) over the circulation of medical devices - if there is information about facts and circumstances that create a threat to the life and health of citizens and medical workers when using and operating medical devices;

c) The absence in the registration dossier of up-to-date information about the authorized representative of the manufacturer (for manufacturers from third countries).

 

115. The decision to suspend the registration certificate (indicating the reasons, date and duration of suspension) is made by the authorized body of the reference state in accordance with the legislation of this state.

116. The duration of suspension of the registration certificate cannot exceed 6 months, while the sale and use of such medical devices in the reference state and the state(s) of recognition are not allowed.

117. The authorized body of the reference state, within 5 working days from the date of making a decision to suspend the registration certificate, enters the corresponding information into the common register of medical devices registered within the Union, and informs the authorized bodies of the states of recognition and the Eurasian Economic Commission about this using the means of the integrated system, as well as the applicant by handing over a notification in person against signature, or sending a notification by registered mail with notification of delivery, or sending it in electronic form or in the form of an electronic document signed with an electronic signature (indicating the reasons, date and duration of suspension of the registration certificate, as well as the need for the applicant to eliminate the circumstances that led to the suspension of the registration certificate).

118. The applicant, within the period established by the authorized body of the reference state, is obliged to eliminate the circumstances that led to the suspension of the registration certificate, and notify this authorized body in writing (with the application of supporting documents). Based on the results of consideration of the documents submitted by the applicant, the authorized body of the reference state makes a decision on the renewal or revocation (cancellation) of the registration certificate (indicating the date of renewal or revocation (cancellation) of the registration certificate).

119. The authorized body of the reference state, within 5 working days from the date of making a decision to renew the registration certificate, enters the corresponding information into the common register of medical devices registered within the Union, and notifies the applicant of the decision made in person against signature, or sends a notification by registered mail with notification of delivery, or sends it in electronic form or in the form of an electronic document signed with an electronic signature.

120. The decision to renew the registration certificate is made in accordance with the legislation of the reference state and enters into force from the date of its adoption.

121. In the event that the applicant does not eliminate the circumstances that led to the suspension of the registration certificate within the established period, the authorized body of the reference state, within 3 working days from the date of expiration of the specified period, makes a decision to revoke (cancel) the registration certificate (with justification).

122. The authorized body of the reference state immediately enters the corresponding information into the common register of medical devices registered within the Union, and notifies the applicant of the revocation (cancellation) of the registration certificate by handing over a notification to the applicant in person against signature, or sending a notification by registered mail with notification of delivery, or sending it in electronic form or in the form of an electronic document signed with an electronic signature.

123. The grounds for the authorized body of the reference state to make a decision to revoke (cancel) a registration certificate or to cancel the registration of a medical device (models (brands) of a medical device, information about which is presented in the registration certificate) are:

a) Submission by the manufacturer of an application for revocation (cancellation) of the registration certificate (on paper and (or) in electronic form) in the form according to Appendix no. 13;

b) Detection of cases of submission by the applicant of unreliable information that could not be established during the registration of the medical device (including during the implementation by authorized bodies of state control (supervision) over the circulation of medical devices);

c) A court decision of the member state that has entered into legal force to revoke (cancel) the registration certificate or to cancel the registration of the medical device (models (brands) of the medical device, information about which is presented in the registration certificate);

d) Submission by the authorized body, based on the results of state control (supervision) over the circulation of medical devices, of information about facts and circumstances that create a threat to the life and health of citizens and medical workers when using and operating the medical device;

e) Loss by the medical device of the status of a medical device due to changes in the acts that are part of the Union law, or on the basis of a decision of the Advisory Committee based on the results of work to resolve disagreements on issues of classifying products as medical devices.

 

124. An application for revocation (cancellation) of a registration certificate may be submitted by the authorized representative of the manufacturer if the following conditions are met simultaneously:

a) The presence in the registration dossier of an up-to-date document confirming the powers of the authorized representative of the manufacturer, or the submission of such a document to the authorized body of the reference state together with the application for revocation (cancellation) of the registration certificate;

b) The submission to the authorized body of the reference state together with the application for revocation (cancellation) of the registration certificate of a document from the manufacturer certified in the established manner confirming its intention to revoke the registration certificate (cancel it).

 

125. If the application for revocation (cancellation) of the registration certificate is submitted in violation of the requirements of these Rules, the documents are not submitted in full or contain unreliable information, the authorized body of the reference state, within 7 working days from the date of receipt of such application and documents, makes a decision to return them (indicating the reasons for the return).

126. The authorized body of the reference state, within 7 working days from the date of occurrence of one of the grounds specified in paragraph 123 of these Rules, makes a decision to revoke (cancel) the registration certificate or to cancel the registration of the medical device (models (brands) of the medical device, information about which is presented in the registration certificate).

127. The authorized body of the reference state, within 5 working days from the date of making a decision to revoke (cancel) a registration certificate or to cancel the registration of a medical device (models (brands) of a medical device, information about which is presented in the registration certificate):

a) Places in the common register of medical devices registered within the Union, information on the revocation (cancellation) of the registration certificate or on the cancellation of the registration of the medical device (models (brands) of the medical device, information about which is presented in the registration certificate);

b) Notifies the applicant of the revocation (cancellation) of the registration certificate by handing over a notification in person against signature, or sending a notification by registered mail with notification of delivery, or sending it in electronic form or in the form of an electronic document signed with an electronic signature;

c) Notifies the applicant of the cancellation of the registration of the medical device (models (brands) of the medical device, information about which is presented in the registration certificate) and of the need to make changes to the registration dossier in terms of excluding the data of these medical devices (models (brands) of the medical device) by handing over a notification in person against signature, or sending a notification by registered mail with notification of delivery, or sending it in electronic form or in the form of an electronic document signed with an electronic signature.

 

Appendix no.1

 to the Rules of registration and expertise of safety, 

quality and effectiveness 

of medical devices

 

FORM OF THE REGISTRATION CERTIFICATE OF A MEDICAL DEVICE AND RULES FOR ITS COMPLETION

(as amended by the Decision of the Council of the Eurasian Economic Commission of December 24, 2021 N 144)

1. Form of the registration certificate of a medical device

 

 

APPENDIX TO THE REGISTRATION CERTIFICATE OF A MEDICAL DEVICE (1)
MI-XY-Z from "" _____ 20 year (2)

(3)

II. Rules for completing the registration certificate of a medical device

1. The registration certificate of a medical device (hereinafter - the registration certificate) is completed by the authorized body of the reference state in Russian using electronic printing devices and, if there is a corresponding requirement in the legislation of the reference state, in the state language of this state.

2. The registration certificate is completed in Russian and the state language of the reference state on different sides of the registration certificate.

3. The registration certificate refers to strict accounting documents and is printed on a form that is manufactured by a printing method and has degrees of protection in accordance with the legislation of the reference state.

If necessary, the name of the manufacturer, its location (address of the legal entity, place of residence of an individual registered as an individual entrepreneur) and information about the products (model, brand, article, etc.) may be indicated using letters of the Latin alphabet.

4. The indication of the names of the manufacturer, the authorized representative of the manufacturer and the production sites in the registration certificate is carried out in the following sequence:

a) for residents of the member states of the Eurasian Economic Union (hereinafter respectively - member states, the Union):

• organizational and legal form;

• full name (for legal entities, it is indicated in quotation marks);

• abbreviated name (in parentheses) (if any);

• name of the state;

 

b) for non-residents of the member states:

• full name

• organizational and legal form;

• abbreviated name (in parentheses) (if any);

• name of the state (in Russian and (or) in the state language of the reference state).

The details are separated by commas.

 

5. The indication of the address in the registration certificate is carried out in the following sequence:

• name of the street (indicating the element of the road network of urban infrastructure), house number, room number (if any);

• name of the settlement (indicating the type);

• name of the district;

• name of the region (oblast, krai) (indicating the type);

• postal code;

• post office box number (if any);

• name of the state.

For non-residents of the member states, the address is indicated using letters of the Latin alphabet.

The details are separated by commas.

 

6. Information about the manufacturer and the authorized representative of the manufacturer, indicated in the registration certificate, the operational document or instructions for use of the medical device, the service manual, as well as in the text of labeling of the medical device, must be identical and correspond to the information indicated in the document or information confirming the registration of the manufacturer and the authorized representative as a legal entity or individual entrepreneur.

7. All fields of the registration certificate must be filled in (in the original registration certificate, there is no numbering of fields).

8. The following is indicated in the registration certificate:

a) in field 1 - the emblem of the Union;

b) in field 2 - a phrase, made in 1 line: 

"EURASIAN ECONOMIC UNION";

c) in field 3 - the full name of the authorized body of the reference state;

d) in field 4 - a phrase, made in 1 line:

"REGISTRATION CERTIFICATE OF A MEDICAL DEVICE";

e) in field 5 - the number of the registration certificate and the date of its issuance.

The number of the registration certificate is formed in the following order:

 

where:

element 1 - medical device;

element 2 - a 2-digit letter code of the reference state in accordance with the international standard ISO 3166-1;

element 3 - a 2-digit letter code of the states of recognition in accordance with the international standard ISO 3166-1 (the codes of the states of recognition that have confirmed agreement on the expert opinion are indicated);

element 4 - a 6-digit serial number of the registration certificate, assigned by the authorized body of the reference state (assigned automatically from the common register of medical devices registered within the Union, the procedure for the formation and maintenance of which is approved by the Decision of the Council of the Eurasian Economic Commission on February 12, 2016 N 30, and remains unchanged when the medical device is circulated within the Union);

 

e) in field 6 - the number and date of the order of the authorized body of the reference state on the registration of the medical device;

f) in field 7 - the full name and location (address of the legal entity) - for a legal entity or the last name, first name, patronymic (if any), place of residence - for an individual registered as an individual entrepreneur;

g) in field 8 - the names and actual addresses of production sites performing the entire process of manufacturing the medical device or its certain stages. If there are two or more production sites, it is allowed to indicate information about them in the appendix to the registration certificate;

h) in field 9 - the full name of the authorized representative of the manufacturer in the territories of the member states, its location (address of the legal entity) - for a legal entity or the last name, first name, patronymic (if any), place of residence - for an individual registered as an individual entrepreneur. In the absence of an authorized representative of the manufacturer in the territory of the member state (if the manufacturer is a resident of the member states), a dash is put in this field;

i) in field 10 - the full name of the medical device, including the trademark and other means of individualization (if any), which must correspond to the name indicated in the expert opinion;

j) in field 11 - the class of potential risk of application of the medical device, confirmed during the examination of the medical device;

k) in field 12 - the names of the reference state and the state(s) of recognition (indicated separated by commas);

l) in field 13 - the number of pages of the appendix to the registration certificate (filled in if there is an appendix);

m) in field 14 - the words "Validity period of the registration certificate of the medical device: indefinitely" are indicated;

n) in field 15 - the date of registration of the medical device, which is indicated in words and numbers: the number - by two Arabic numerals (in quotation marks), the month - by a word, the year - by four Arabic numerals (indicating the abbreviated designation of the year "g.");

o) in field 16 - the date of the last amendment to the registration certificate, which is indicated in words and numbers: the number - by two Arabic numerals (in quotation marks), the month - by a word, the year - by four Arabic numerals (indicating the abbreviated designation of the year "g."). This field is filled in when making changes to the registration dossier with the issuance of a new registration certificate with the same number and indicating the number of the corresponding order on making changes;

p) in field 17 - the position, signature, last name, first name, patronymic (if any) of the head (authorized person) of the authorized body that issued the registration certificate, certified by the seal of this authorized body (if any). The use of a facsimile instead of a signature is not allowed;

q) in field 18 - the printing number, series and serial number of the registration certificate form, affixed during its manufacture.

 

9. If there is information about the models (brands) of the medical device, their composition and accessories or two or more production sites, an appendix to the registration certificate is filled in, which is an integral part of the registration certificate. Each page of the appendix must be numbered. The following is indicated in the appendix to the registration certificate:

 

1. in field 1 - a phrase, made in 2 lines:

"APPENDIX TO THE REGISTRATION CERTIFICATE

MEDICAL DEVICE";

b) in field 2 - the number of the registration certificate;

c) in field 3 - models (brands) of the medical device, their composition and accessories (if any);

d) in field 4 - the names and actual addresses of production sites performing the entire process of manufacturing the medical device or its certain stages (if it is necessary to indicate information about two or more production sites);

e) in field 5 - the position, signature, last name, first name, patronymic (if any) of the head (authorized person) of the authorized body that issued the registration certificate, certified by the seal of the authorized body (if any). The use of a facsimile instead of a signature is not allowed;

f) in field 6 - the page number of the appendix is indicated;

g) in field 7 - the printing number affixed during the manufacture of the appendix form.

 

10. When filling out the registration certificate and (or) the appendix to it, the indication of information not provided for by these Rules, as well as the use of abbreviations of words (except for generally accepted ones) and the correction of text are not allowed.

11. In case of loss or damage to the registration certificate, the authorized body of the reference state issues a duplicate of this registration certificate. At the same time, in the upper right corner of the registration certificate, the marks are placed: "Duplicate issued "" _____ 20 year" and "The original registration certificate of the medical device is recognized as invalid"

 

Appendix no.2 

to the Rules of registration and expertise of safety, 

quality and effectiveness of medical devices

FORM OF THE APPLICATION FOR CARRYING OUT THE EXAMINATION OF A MEDICAL DEVICE

(as amended by the Decision of the Council of the Eurasian Economic Commission of December 24, 2021 N 144)

APPLICATION FOR CARRYING OUT THE EXAMINATION OF A MEDICAL DEVICE

 

Appendix N 3 

to the Rules of registration and expertise of safety,

 quality and effectiveness of medical devices

FORM OF THE APPLICATION FOR CARRYING OUT THE REGISTRATION OF A MEDICAL DEVICE

(as amended by the Decision of the Council of the Eurasian Economic Commission of December 24, 2021 N 144)

 

APPLICATION FOR CARRYING OUT THE REGISTRATION OF A MEDICAL DEVICE

(full and abbreviated (if any), including the trade name, name of the person on whose behalf the registration is made (manufacturer (authorized representative of the manufacturer), organizational and legal form of the legal entity)
hereby requests to carry out the registration of a medical device

 

Appendix no.4 

to the Rules of registration and expertise of safety, 

quality and effectiveness of medical devices 

LIST OF DOCUMENTS NECESSARY FOR THE REGISTRATION OF A MEDICAL DEVICE

(as amended by the Decision of the Council of the Eurasian Economic Commission of December

24, 2021 N 144)

 

 

 

Appendix no.5 

to the Rules of registration and expertise of safety, 

quality and effectiveness of medical devices

EXPERT OPINION ON THE ASSESSMENT OF SAFETY, QUALITY AND EFFECTIVENESS OF A MEDICAL DEVICE
(as amended by the Decision of the Council of the Eurasian Economic Commission on 24 December, 2021 no. 144)

 

EXPERT OPINION ON THE ASSESSMENT OF SAFETY, QUALITY AND EFFECTIVENESS OF A MEDICAL DEVICE

N ___ from "_" _________ 20 year

1. General information about the medical device:
a) number and date of registration of applications for carrying out the examination of the medical device and for carrying out the registration of the medical device;
b) name of the medical device;
c) manufacturer of the medical device, country;
d) production site (sites), country;
e) authorized representative of the manufacturer (if any);
f) scope of application and purpose;
g) type of medical device in accordance with the nomenclature of medical devices of the Eurasian Economic Union, the rules for the maintenance of which are approved by the Decision of the Collegium of the Eurasian Economic Commission on 29 December, 2015 no.177;
h) class of potential risk of application of the medical device;
i) composition of the medical device (models (brands) of the medical device (if any)) and accessories to it (if any);
j) main technical characteristics of the medical device (models (brands, types) of the medical device (if any)).

2. Results of the examination of safety, quality and effectiveness of the medical device (as applicable):
a) assessment of the correctness of classifying the product as a medical device;
b) assessment of the conformity of the class of potential risk of application of the medical device indicated by the applicant in accordance with the Rules for classifying medical devices depending on the potential risk of application, approved by the Decision of the Collegium of the Eurasian Economic Commission on 22 December, 2015 no.173

c) assessment of the correctness of classifying the medical device (models (brands) of the medical device) to a certain type of medical device in accordance with the nomenclature of medical devices of the Eurasian Economic Union, the rules for the maintenance of which are approved by the Decision of the Collegium of the Eurasian Economic Commission on 29 December, 2015 no.177;
d) assessment of the conformity of models (brands) of the medical device (if any), included in one registration certificate, to the criteria established by paragraph 19 of the Rules of Registration and Examination of Safety, Quality and Effectiveness of Medical Devices, approved by the Decision of the Council of the Eurasian Economic Commission on 12 February, 2016 no.46;
e) analysis and assessment of evidentiary documents (materials) confirming the conformity of the medical device to the General requirements for the safety and effectiveness of medical devices, requirements for their labeling and operational documentation, approved by the Decision of the Council of the Eurasian Economic Commission on 12 February, 2016 no,27 (hereinafter - the General requirements):
analysis of the information provided by the manufacturer on the conformity of the medical device to the General requirements, including analysis of the correctness of identifying the provisions of the General requirements applicable to the medical device;
assessment of the conformity of technical test reports issued by authorized organizations to the Rules for Conducting Technical Tests of Medical Devices, approved by the Decision of the Council of the Eurasian Economic Commission on 12 February, 2016 no.28;
assessment of the conformity of the protocols of studies (tests) for the purpose of assessing the biological effect of medical devices issued by authorized organizations to the Rules for Conducting Studies (Tests) for the purpose of assessing the biological effect of medical devices, approved by the Decision of the Council of the Eurasian Economic Commission on 16 May, 2016 no.38;
analysis of the report on the assessment of the biological effect of the medical device (carried out, inter alia, to confirm that the materials in contact (interacting) with human tissues are identified (the brands of materials and their manufacturers are indicated), as well as to confirm the validity of the absence of the need to conduct studies (tests) for the purpose of assessing the biological effect);
analysis of the report on the clinical evidence of the effectiveness and safety of the medical device (carried out to confirm the validity of the choice of methods for proving the clinical effectiveness and safety of the medical device, the validity of the data used to prove the clinical effectiveness and safety of the medical device, as well as the validity of the conclusion on clinical effectiveness and safety for all declared indications for use, taking into account the presence or absence of contraindications);
assessment of the conformity of reports on clinical (clinical and laboratory) trials (research) of medical devices to the Rules for Conducting Clinical and Clinical Laboratory Trials (Research) of Medical Devices, approved by the Decision of the Council of the Eurasian Economic Commission on 12 February, 2016 no.29;
analysis of the validity of the evidence of the first party (if any) to confirm the conformity of the medical device to the General requirements, taking into account the class of potential risk of application of the medical device (for medical devices of potential risk classes 2b and 3, the test (research) program and the justification for the chosen methods must be attached to the evidence of the first party);

analysis of the standards applied by the manufacturer in the design and manufacture of the medical device;
analysis of the safety and effectiveness of the medicinal product in the composition of the medical device, its impact on the functionality of the medical device, the compatibility of the medicinal product with the medical device (except for medical devices for in vitro diagnostics). The medicinal product must be registered and authorized for use in the state - the manufacturer of the medicinal product;
analysis of data on the biological safety of the medical device based on the analysis of all materials of animal or human origin included in the medical device, as well as information on the selection of sources (donors), material selection, processing, storage, testing, validation of testing procedures, as well as handling tissues, cells, substances of animal or human origin, cultures of microorganisms and viruses;
analysis of the procedure and methods of sterilization of the medical device, materials substantiating the method of sterilization, proposed methods of quality control and determination of residues of the sterilizing substance when using the chemical method of sterilization;
study of the validity of the software based on the analysis of data on its verification and validation, including information on its development, measures and means of protection against unauthorized access and ensuring cybersecurity, testing by the manufacturer, data on identification and labeling;
analysis of the report on the stability of the medical device, the validity of the declared shelf life;
review of the risk analysis report in order to confirm the completeness of the hazards, dangerous situations and corresponding risks identified in such report, which can be assessed as unacceptable, as well as confirmation of the manufacturer's conclusion on the absence of unacceptable risks or the admissibility of risks that are assessed as acceptable in the risk analysis report based on the analysis of the "risk-benefit" ratio;
confirmation on the basis of the presented evidentiary materials (documents) of the validity of the manufacturer's assessment of the conformity of the medical device to the General requirements;
assessment of the conformity of the operational document or instructions for use, the service manual to the General requirements; assessment of the conformity of the labeling of the medical device to the General requirements;
analysis of the requirements for the technical characteristics of the medical device;

assessment of documents confirming the results of tests of medical devices for the purpose of approving the type of measuring instruments (in relation to medical devices included in the list of types of medical devices subject to classification during their registration as measuring instruments, approved by the Decision of the Council of the Eurasian Economic Commission on 12 February, 2016 no.42);

for the purpose of confirming the conformity of the declared medical device to a group (subgroup) of medical devices, taking into account the class of potential risk of application in accordance with Appendix N 2 to the Requirements for the implementation, maintenance and assessment of the quality management system of medical devices, depending on the potential risk of their application, approved by the Decision of the Council of the Eurasian Economic Commission on 10 November, 2017 no.106, as well as confirming the reliability of information about the production sites indicated in the applications for registration and examination, to which the report on the results of inspection of the medical device production applies);
f) analysis of data on the certification of the quality management system (if any), including the requirements for compliance with which the manufacturer's quality management system is certified, and information about certificates (number, date of issue, validity period of the certificate, name and information about the accreditation of the certification body);
g) confirmation of the validity of indicating the production sites of the registered medical device;
h) analysis of data on the development and production of the medical device (schemes of production processes, main stages of production, packaging, testing and procedure for releasing the final product);
i) analysis of the information on marketing submitted by the manufacturer;
j) analysis of the information provided by the manufacturer on the presence or absence of reports of adverse events and (or) accidents related to the use of the medical device, recalls from the market of the medical device, safety notices of the medical device, approaches to solving such problems by the manufacturer in their occurrence, descriptions of the corrective actions taken, as well as analysis of the ratio of sales level, number of accidents and recalls of the medical device from circulation;
k) analysis of the plan for collecting data on the safety and effectiveness of the medical device at the post-sale stage.
3. General conclusion on the confirmation (non-confirmation) of the safety, quality and effectiveness of the medical device, a recommendation on the possibility (impossibility) of registering the medical device.

I have been warned of the responsibility for the accuracy of the information stated in the expert opinion on the assessment of the safety, quality and effectiveness of the medical device.

 

Appendix no.6
to the Rules of registration and expertise of
safety, quality and effectiveness of
medical devices

CONCLUSION ON CONFIRMING THE AGREEMENT (DISAGREEMENT) ON THE EXPERT OPINION BASED ON THE RESULTS OF THE EXPERTISE OF SAFETY, QUALITY AND EFFECTIVENESS OF THE MEDICAL DEVICE OF THE MEMBER STATE OF THE EURASIAN ECONOMIC UNION CARRYING OUT THE REGISTRATION OF THE MEDICAL DEVICE

(as amended by the Decision of the Council of the Eurasian Economic Commission of December 24, 2021 N 144)

"" ________ 20 year

CONCLUSION ON CONFIRMING THE AGREEMENT (DISAGREEMENT) ON THE EXPERT OPINION OF THE MEMBER STATE OF THE EURASIAN ECONOMIC UNION CARRYING OUT THE REGISTRATION OF THE MEDICAL DEVICE, BASED ON THE RESULTS OF THE EXPERTISE OF SAFETY, QUALITY AND EFFECTIVENESS OF THE MEDICAL DEVICE

N ____ from "_" _________ 20 year

1. Name of the authorized body (expert organization) of the member state of the Eurasian Economic Union carrying out the registration of the medical device (hereinafter - the reference state).
2. Date of posting of the expert opinion in the information system of the authorized body (expert organization) of the reference state.
3. Number of the expert opinion.
4. Name of the medical device (indicating the model (brand) of the medical device, its composition and accessories).
5. Manufacturer of the medical device (full and abbreviated names, organizational and legal form of the legal entity, location (address of the legal entity, place of residence of the physical person registered as an individual entrepreneur)).
6. Production sites (full and abbreviated names, organizational and legal form of the legal entity, actual address).
7. Authorized representative of the manufacturer (full and abbreviated names, organizational and legal form of the legal entity, location (address of the legal entity, place of residence of the physical person registered as an individual entrepreneur)) (if any).
8. Applicant.
9. Analysis of the expert opinion submitted by the authorized body (expert organization) of the reference state on the results of the expertise of safety, quality and effectiveness of the medical device, as well as the conformity of the documents of the registration dossier to the established requirements.
10. Confirmation of the correctness of the translation of the operational document or instructions for use of the medical device, the service manual, the text of labeling of the medical device into the state language in accordance with the requirements of the legislation of the member state of the Eurasian Economic Union (if applicable).
11. Results of the expertise (the conclusions on the separate aspects of the expert opinion are indicated).
12. Conclusion (the general conclusion is indicated, in case of disagreement with the expert opinion - with justification of the reasons).
13. Information about the experts (Full name, academic degree (title) (if any), place of work and position).

I have been warned of the responsibility for the accuracy of the information stated in the conclusion on confirming the agreement (disagreement) on the expert opinion of the reference state based on the results of the expertise of safety, quality and effectiveness of the medical device.

 

Appendix no.7
to the Rules of registration and expertise of
safety, quality and effectiveness of
medical devices

FORM OF THE APPLICATION FOR MAKING CHANGES TO THE REGISTRATION DOSSIER OF A MEDICAL DEVICE
(as amended by the Decision of the Council of the Eurasian Economic Commission of December 24, 2021 N 144)

APPLICATION FOR MAKING CHANGES TO THE REGISTRATION DOSSIER OF A MEDICAL DEVICE

(full and abbreviated (if any), including the trade name, name of the person on whose behalf the changes are made (manufacturer (authorized representative of the manufacturer), organizational and legal form of the legal entity)
hereby requests to make changes to the registration dossier of the medical device

due to the following changes:

Making changes to the registration dossier does not entail changes in properties and characteristics that affect the safety, quality and effectiveness of the medical device.
I guarantee the accuracy of the information provided.
I guarantee the preservation of the declared safety and effectiveness characteristics of the medical device throughout its entire service life, subject to compliance with the conditions of operation, transportation and storage of the medical device in accordance with the manufacturer's requirements.

 

Appendix no.8
to the Rules of registration and expertise of
safety, quality and effectiveness of
medical devices

EXPERT OPINION ON THE POSSIBILITY (IMPOSSIBILITY) OF MAKING CHANGES TO THE REGISTRATION DOSSIER OF A MEDICAL DEVICE
(as amended by the Decision of the Council of the Eurasian Economic Commission of December 24, 2021 N 144)

EXPERT OPINION ON THE POSSIBILITY (IMPOSSIBILITY) OF MAKING CHANGES TO THE REGISTRATION DOSSIER OF A MEDICAL DEVICE

N ___ from "_" ___________ 20 year

1. Name of the medical device.

2. Manufacturer of the medical device (full and abbreviated names, organizational and legal form of the legal entity, location (address of the legal entity, place of residence of the physical person registered as an individual entrepreneur)).

3. Authorized representative of the manufacturer (full and abbreviated names, organizational and legal form of the legal entity, location (address of the legal entity, place of residence of the physical person registered as an individual entrepreneur)) (if any).

4. Production sites (full and abbreviated names, organizational and legal form of the legal entity, actual address).

5. Scope of application and purpose.

6. Type of medical device in accordance with the nomenclature of medical devices of the Eurasian Economic Union, the rules for the maintenance of which are approved by the Decision of the Collegium of the Eurasian Economic Commission on December 29, 2015 N 177.

7. Class of potential risk of application of the medical device.

8. Number of the registration certificate of the medical device.

9. Date of issuance of the registration certificate of the medical device.

10. Changes to be made:

11. Analysis and assessment of data justifying the making of changes.
12. Conclusion on the possibility (impossibility) of making changes to the registration dossier of the medical device (in case of a negative conclusion - with justification of the reasons).

Appendix no.9
to the Rules of registration and expertise of
safety, quality and effectiveness of
medical devices

FORM OF THE APPLICATION FOR MAKING CHANGES TO THE REGISTRATION DOSSIER OF A MEDICAL DEVICE IN A NOTIFICATION PROCEDURE
(as amended by the Decision of the Council of the Eurasian Economic Commission of December 24, 2021 N 144)

APPLICATION FOR MAKING CHANGES TO THE REGISTRATION DOSSIER OF A MEDICAL DEVICE IN A NOTIFICATION PROCEDURE

hereby requests to make changes to the registration dossier of the medical device in a notification procedure

due to the following changes:

 

Making changes to the registration dossier does not entail changes in properties and characteristics that affect the safety, quality and effectiveness of the medical device.

I guarantee the accuracy of the information provided.

I guarantee the preservation of the declared safety and effectiveness characteristics of the medical device throughout its entire service life, subject to compliance with the conditions of operation, transportation and storage of the medical device in accordance with the manufacturer's requirements.

Appendix no.10
to the Rules of registration and expertise of
safety, quality and effectiveness of
medical devices

FORM OF THE APPLICATION FOR ISSUING A DUPLICATE OF THE REGISTRATION CERTIFICATE OF A MEDICAL DEVICE
(as amended by the Decision of the Council of the Eurasian Economic Commission of December 24, 2021 N 144)

APPLICATION FOR ISSUING A DUPLICATE OF THE REGISTRATION CERTIFICATE OF A MEDICAL DEVICE

 

 

Appendix no.11
to the Rules of registration and expertise of
safety, quality and effectiveness of
medical devices

FORM OF THE APPLICATION FOR CARRYING OUT THE AGREEMENT ON THE EXPERT OPINION ON THE REGISTERED MEDICAL DEVICE
(as amended by the Decision of the Council of the Eurasian Economic Commission of December 24, 2021 N 144)

APPLICATION FOR CARRYING OUT THE AGREEMENT ON THE EXPERT OPINION ON THE REGISTERED MEDICAL DEVICE

(full and abbreviated (if any), including the trade name, name of the person on whose behalf the changes are made (manufacturer (authorized representative of the manufacturer), organizational and legal form of the legal entity)
hereby requests to make changes to the registration dossier of the medical device:

I guarantee the accuracy and identity of the information contained in the application.

 

Appendix no.12
to the Rules of registration and expertise of
safety, quality and effectiveness of
medical devices
LIST OF DOCUMENTS NECESSARY FOR CARRYING OUT THE PROCEDURE OF AGREEING ON THE EXPERT OPINION ON THE REGISTERED MEDICAL DEVICE
(as amended by the Decision of the Council of the Eurasian Economic Commission of December 24, 2021 N 144)

Appendix no.13
to the Rules of registration and expertise of
safety, quality and effectiveness of
medical devices

FORM OF THE APPLICATION FOR REVOKING (CANCELLING) THE REGISTRATION CERTIFICATE OF A MEDICAL DEVICE
(as amended by the Decision of the Council of the Eurasian Economic Commission of December 24, 2021 N 144)

APPLICATION FOR REVOKING (CANCELLING) THE REGISTRATION CERTIFICATE OF A MEDICAL DEVICE

(full and abbreviated (if any), including the trade name, name of the person on whose behalf the changes are made (manufacturer (authorized representative of the manufacturer), organizational and legal form of the legal entity)
hereby requests to make changes to the registration dossier of the medical device: