Order of Russian Government 1416 from 27.12.2012

Translated file includes changes from Order of Russian Government 633 from 30.05.2018. Original Russian document – http://www.consultant.ru/ , translation made for Company BW (beawire).

GOVERNMENT OF THE RUSSIAN FEDERATION

DECREE dated 27 December 2012 No. 1416

ON THE APPROVAL OF THE RULES STATE REGISTRATION OF MEDICAL DEVICES

In accordance with Article 38 of the Federal Law “On the Fundamentals of the Healthcare of Citizens in the Russian Federation” the Government of the Russian Federation decrees:

1.To approve the Rules of the state registration of medical devices enclosed herewith.

2.It shall be established that:

a) registration certificates for medical devices and medical equipment with a fixed period of validity that had been issued before the day that this decree entered into force, are valid until the expiry date specified in them;

b) registration certificates for medical devices and medical equipment with a permanent period of validity that had been issued before the day that this decree entered into force, are valid and are due to be replaced before 1 January 2021 for the registration certificates in a form approved by the Federal Service for Surveillance in Healthcare.

A registration certificate is replaced without a procedure of the state registration of medical devices on the basis of an application filed by the applicant to the Federal Service for Surveillance in Healthcare, stating the information specified by the Rules approved by this decree.

  1. The state registration of medical devices submitted for the state registration before the effective day of this decree is performed on the basis of the documents submitted before the before the effective day of this decree, as well as an application for the state registration of a medical device submitted by the applicant in accordance with the Rules approved by this decree, to the Federal Service for Surveillance in Healthcare.
  2. The implementation of the powers conferred by this Decree shall be within the range of the maximum number of central office employees of the Federal Service for Surveillance in Healthcare and budgetary allocations provided to the Service in the federal budget for management and administration in the sphere of designated functions established by the Government of the Russian Federation.
  3. This Decree becomes effective from 1 January 2013.

 

Chairman of the Government

Of the Russian Federation

MEDVEDEV

 

Approved

by Decree of the Government

Of the Russian Federation

dated 27 December 2012 No. 1416

 

RULES STATE REGISTRATION OF MEDICAL DEVICES

1. These Rules establish the procedure for the state registration of medical devices to be circulated on the territory of the Russian Federation.

2. Subject to state registration are any instruments, apparatuses, devices, equipment, materials and other items used for medical purposes individually or combined, and also together with other accessories necessary for the operation of the said items as per indications; this includes specific software products and medical devices intended by the producer (manufacturer) for the prevention, diagnostics, treatment and medical rehabilitation of diseases, for the monitoring of human body parameters, for medical investigations, recovery, substitution, change of the anatomical structures or physiological functions of the body, for the prevention or termination of pregnancy, and their functionality is not performed by means of the pharmacological, immunological, genetic or metabolic effect on the human body (hereinafter referred to as medical devices).

Patient custom-made medical devices that are to meet special requirements for the appointment of medical professionals and are intended solely for the personal use of an individual patient, are not subject to the state registration.

3. The state registration of medical devices is performed by the Federal Service for Surveillance in Healthcare (hereinafter referred to as the registration authority).

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

“safety of a medical device” is the absence of any unacceptable risk of harm to human life, human health and the environment by using a medical device for its intended purpose under conditions prescribed by the producer (manufacturer);

“quality of a medical device” is the totality of features and characteristics of the medical device affecting its ability to function as intended if it meets the requirements of the regulatory, technical and operational documentation of the producer (manufacturer);

“clinical trials” are the designed and planned systematic study undertaken with or without the involvement of a human subject to evaluate the safety and efficiency of a medical device;

“regulatory documents” are the documents governing the requirements for safety, quality, and estimated efficiency provided by the intended use and methods of control of conformity of the medical device with these requirements;

“registration dossier” is a set of documents to be submitted for state registration, making amendments into such documents for the medical device, as well as copies of the decisions adopted by the registration authority for a particular medical device;

“technical documentation of the producer (manufacturer)” is the documents governing the design of a medical device, establishing technical requirements and providing the data for its development, production, use, operation, maintenance, repair, disposal or destruction;

“technical tests” are tests to determine whether the characteristics (properties) of the medical device meet the requirements of the regulatory, technical and operational documentation of the producer (manufacturer) and making a subsequent decision on the possibility of conducting clinical trials;

“toxicological studies” are studies to assess the biological safety of a medical device and to make a subsequent decision on the possibility of conducting clinical trials;

“an authorised representative of the producer (manufacturer)” is the legal entity or an individual entrepreneur registered in the territory of the Russian Federation and authorised by the producer (manufacturer) of the medical device to represent its interests with respect to the issues related to the circulation of the medical device in the territory of the Russian Federation, including issues related to the procedures for the assessment of compliance and state registration that may act as the holder of the relevant marketing authorisation for the medical device;

“operational documentation of the producer (manufacturer)” is the documents intended to familiarise the user with the design of a medical device, regulating the terms and rules of operation (intended use, maintenance, current repair, storage and transportation), values of the key parameters, characteristics (properties) of the medical device guaranteed by the producer (manufacturer), warranty, as well as information on its disposal or destruction;

“effectiveness of a medical device” is the totality of features and characteristics of the medical device to ensure meeting the intended objectives specified by the producer (manufacturer) and confirmed by the practice of clinical use.

5. The state registration of medical devices is performed on the basis of the results of technical tests, toxicity studies, and clinical trials that are forms of conformity assessment of medical devices with the classification depending on the potential risk of their use, and evaluation of the quality, effectiveness and safety of medical devices, as well as tests for approval of a type of measuring instruments (in relation to medical devices related to measuring instruments in the field of the state regulation of traceability, the list of which is approved by the Ministry of Health of the Russian Federation).

Ensuring the organisation of work on the formation and management of the nomenclature classification of medical devices by type is carried out by the registration authority.

When changing the type of a medical device while forming and managing the nomenclature classification of medical devices by type, as approved by the Ministry of Health of the Russian Federation, the registration authority shall enter the corresponding change into the state register of medical devices and organisations (individual entrepreneurs) that manufacture medical devices (hereinafter referred to as the state register) and notifies the legal entity or individual entrepreneur in whose name a registration certificate is issued for a medical device whose type has been changed within 20 working days from the date of entering the change in the registry record of the state register.

 6. The document confirming the fact of the state registration of a medical device is a registration certificate for a medical device (hereinafter a registration certificate). The format of the registration certificate is approved by the registration authority.

A registration certificate is issued for an indefinite term.

7. The state fee shall be paid in accordance with the laws of the Russian Federation governing taxes and fees.

Information on payment of the state fee is requested by the registration authority by way of an inter-departmental information exchange, in accordance with the Federal Law “On the organisation of state and municipal services.”

8. For the state registration of a medical device the developer, producer (manufacturer) of a medical device or the authorised representative of the producer (manufacturer) (hereinafter the applicant) either presents or sends the application for the state registration of a medical device, as well as the documents referred to in paragraph 10 of these Rules, to the registration authority.

9. The application for the state registration of a medical device (hereinafter “registration application”) shall contain the following information:

a) name of the medical device (with the accessories required for the use of a medical device as intended) and the applicant shall indicate the trademark and other means of individualisation of the medical device in the event of their application to the packaging of the medical device;

b) with respect to the developer, full and (if available) short name, including business name, legal form of the legal entity, address of the location or surname, name and patronymic (if available), details of the identity document, address of the place of residence of the individual entrepreneur, as well as the phone numbers and e-mail address of the legal entity or individual entrepreneur (if available);

c) with respect to the producer (manufacturer) of the medical device, full and (if available) short name, including business name, legal form of the legal entity, address of the location or surname, name and patronymic (if available), details of the identity document, address of the place of residence of the individual entrepreneur, as well as the phone numbers and e-mail address of the legal entity or individual entrepreneur (if available);

d) with respect to the manufacturer’s authorised representative, full and (if available) short name, including business name, legal form of the legal entity, address of the location or surname, name and patronymic (if available), details of the identity document, address of the place of residence of the individual entrepreneur, as well as the phone numbers and e-mail address of the legal entity or individual entrepreneur (if available);

e) with respect to the legal entity in whose name the registration certificate may be issued, full and (if available) short name, including business name, legal form of the legal entity, address of the location or surname, name and patronymic (if available), details of the identity document, address of the place of residence of the individual entrepreneur, as well as the phone numbers and e-mail address of the legal entity or individual entrepreneur (if available);

f) place of manufacture of the medical device;

g) the medical device designation as established by the producer (manufacturer);

h) the type of the medical device in accordance with the nomenclature classification of medical devices;

i) the class of the potential risk of a medical device’s application in accordance with the nomenclature classification of medical devices;

j) the code of the All-Russian Classification of Products by economic activity;

k) information on the method of obtaining the registration certificate, as well as information relating to the procedure of state registration of a medical device.

10. The following documents shall be provided for the state registration of the medical device:

a) a copy of the document confirming the authority of the producer’s (manufacturer’s) authorised representative

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

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

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

e) photographic images of the general configuration of the medical device together with the accessories needed for its intended application (in size at least 18 x 24 cm);

f) documents confirming the findings of technical tests of the medical device;

g) documents confirming the findings of toxicological studies of a medical device, the use of which implies contact with the human body;

h) documents confirming the findings of tests of the medical device in order to approve the type of measuring instruments (in relation to medical devices related to measuring instruments in the field of the state regulation of traceability, the list of which is approved by the Ministry of Health of the Russian Federation).

i) list of documents;

j) for medical devices of class 1 potential risk of use and medical devices for in vitro diagnostics: information supporting the clinical effectiveness and safety of medical devices;

k) a draft plan of clinical trials for the medical device with any substantiating materials (if available).

l) information on permits for the import of medical devices issued by the registration authority for the purpose of their state registration (for medical devices of foreign manufacture);

m) copies of the documents confirming the quality of the medicinal product, pharmaceutical substance, biological material and other substance using which the medical device was manufactured or that are included in its composition and which are intended for use only taking into account the purpose of the medical device specified by the manufacturer and issued in accordance with the legislation of the country of origin of the drug, pharmaceutical substance, biological material and other substance.

11. If the documents referred to in paragraph 10 of these Rules, are drawn up in a foreign language, they shall be presented with a duly certified translation into Russian.

12. The deadlines and the sequence of administrative procedures and administrative efforts taken by the registration authority shall be set forth in the Administrative Regulations on the Provision of the Governmental Service involving the state registration of medical devices as developed in accordance with Decree No. 373 of the Government of the Russian Federation dated May 16, 2011.

13. The registration application and the documents referred to in paragraph 10 of the Rules shall be submitted by the applicant to the registration authority in hard copy by hand or sent by registered mail with a return receipt, and the list of enclosures or as soft copy signed by electronic signature.

The registration authority shall receive the registration application and the documents referred to in paragraph 10 of these Rules, according to the list of contents, a copy of which is marked with the receipt date of the application and documents on the date of receipt, shall be given to the applicant or sent to the applicant by registered mail with a return receipt requested or as soft copy via telecommunication channels.

14. The registration authority shall not require the applicant to indicate any information that is not provided for by paragraph 9 of these Rules, or submit documents not provided for by paragraph 10 of these Rules.

15. Within 5 business days from the receipt of the registration application and the documents required by paragraph 10 of these Rules, the registration authority shall verify the completeness and accuracy of the information contained in them, in particular by comparing such information with the information presented by way of an inter-departmental information exchange.

16. If the registration application is made in violation of the provisions of paragraph 9 of these Rules, and (or) in a statement provides false information or documents required by paragraph 10 of these Rules have not been provided in full, the registration authority shall give the applicant a notice to rectify the identified violations and/or to submit the missing documents within a 30-days period, or send such notice by registered mail, with a return receipt, or in the form of an electronic document signed by electronic signature, or in electronic form via telecommunication channels.

If being sent by registered mail the Notice is considered received after 10 working days from the date of sending the notice.

17. Within 3 business days from the date of submission of the duly issued registration application and of the full set of documents required by paragraph 10 of these Rules, and also if the identified violations are rectified and/or the documents required by paragraph 10 of these Rules are submitted within the 30-day period, the registration authority shall make a decision to start the state registration of the medical device.

18. If the identified violations have not been rectified and/or the missing documents have not been provided within 30 days, the registration authority shall make a decision to return the registration application and documents required by paragraph 10 of these Rules, with reasoned grounds for their return.

19. The state registration of medical devices shall be carried out by the registration authority within a period of up to 50 business days following the date when the decision to start the state registration of medical devices was made.

The duration of the clinical trials of the medical device shall not be included into this 50-days’ period.

20. Within 3 business days from the date of making a decision as to the start of state registration of medical devices, the registration authority shall issue and make available an assignment for conducting an expert evaluation of the quality, efficiency and safety of the medical device to the Federal State Budgetary Institution (hereinafter the “expert institution”).

21. The expert institution shall carry out an expert evaluation of the quality, efficiency and safety of the medical device on a stage-by-stage basis in accordance with the procedure established by the Ministry of Health of the Russian Federation:

a) at Stage I the expert evaluation of the registration application and the documents referred to in paragraph 10 of these Rules is conducted to determine the possibility (impossibility) of carrying out clinical trials of the medical device (except for medical devices of the potential risk class 1 of the use and medical devices for in vitro diagnostics);

b) at Stage II there is an expert evaluation of the completeness and findings of the conducted technical tests, toxicology studies, clinical trials, as well as the trials intended to approve the type of measuring tools (with respect to medical devices classified as measuring tools in the field of the state regulation of traceability, the list of which is approved by the Ministry of Health of the Russian Federation) (hereinafter the “expert evaluation of the completeness and findings of trials and studies”).

21(1). During the expert evaluation of the quality, efficiency and safety of the medical device (at any stage), the expert institution cannot demand any materials that are necessary for carrying out the evaluation from the applicant or from any other individuals.

In the event that there is insufficient information and material contained in the statement submitted by the applicant for registration, and in the documents referred to in paragraph 10 of these Rules for the expert to reach a conclusion, the expert raises the question of being provided with the necessary materials and information to the head of the expert institution, who then refers the request to the registration authority that issued the order for conducting the examination. The registration authority sends the applicant a request for the necessary information indicating the nature of the comments and how to resolve them within 2 working days of receipt of a request from the head of the expert institution. This request shall be sent only once at each stage of the evaluation of the quality, efficiency and safety of the medical device and can be transmitted to the authorised representative of the applicant personally with signature upon receipt, sent by registered mail or transmitted in electronic form via telecommunication channels or in the form of an electronic document signed by electronic signature.

The applicant must submit a response to the request of the registration authority within a period not exceeding 50 business days from the date of receipt of the request. Within 2 working days of receipt of the applicant’s response to the request, the registration authority shall send a reply to the expert institution. If the applicant fails to submit a response within 50 business days, the registration authority within 2 business days sends to the expert institution a notice of non-response regarding the registration authority’s request for the preparation of a conclusion to be reached by the expert institution based on the available documents.

The time from the day of sending the registration authority’s request to the date of receiving an answer to the request, or a notice of non-response, is not considered when calculating the period of evaluation of the quality, efficiency and safety of the medical device.

If the answer to the request, as well as the documents attached to it, are in a foreign language, they shall be presented with a duly certified translation into Russian.

If the registration authority identifies inaccurate and (or) insufficient data in the documents submitted by the applicant in response to a request or the documents in or containing text in a foreign language without it having been translated into Russian through the established procedure, the registration authority shall submit (send as registered mail with notification of delivery within 2 working days or as soft copy signed with an electronic signature, or in electronic form via telecommunication channels) to the applicant a decision on the return of such documents with a reasoned justification for their return and a notice of possible re-submission of the modified documents by the applicant before the expiry of 50 business days from receipt of the request. If the applicant fails to submit the requested materials and information within the specified time, the expert evaluation of the quality, efficiency and safety of the medical device continues on the documents and information submitted by the applicant earlier and contained in the registration dossier at the disposal of the expert institution.

22. At Stage I of the expert evaluation of the quality, efficiency and safety of the medical device, the expert institution shall perform the following actions within a period of up to 20 business days following receipt of the assignment:

a) conduct an expert evaluation of the registration application and documents referred to by paragraph 10 of these Rules to determine the possibility (impossibility) of carrying out clinical trials of the medical device;

b) issue and despatch of the conclusion to the registration authority as to the possibility (impossibility) of carrying out clinical trials of the medical device (indicating the reasons for and justifying the impossibility of conducting them), the format of which shall be approved by the Ministry of Health of the Russian Federation.

23. The following shall substantiate the opinion by the expert institution on the impossibility of conducting clinical trials of a medical device or the impossibility of the state registration of a medical device:

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

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

24. The registration authority shall take the following actions within 5 business days following receipt of the conclusion on the possibility (impossibility) of conducting clinical trials of a medical device from the expert institution:

a) assessment of the conclusion to determine its conformity with the assignment for performing an expert evaluation of the quality, efficiency and safety of the medical device. If any discrepancy of the expert institution’s conclusion with the specified assignment is established, such conclusion shall be returned to the expert institution for finalisation, the term of which is not more than 2 business days from the day the expert institution received the returned conclusion;

b) taking a decision on issuing a permit to conduct clinical trials of a medical device or denial to carry out the state registration of the medical device that is issued by an order of the registration authority, and notification of the applicant as to the decision taken;

c) issuing (sending as registered mail with notification of delivery or as soft copy signed by electronic signature) to the applicant the permit to conduct clinical trials of a medical device, the format of which shall be approved by the registration authority, and entry of the appropriate information in the register of issued permits to conduct clinical trials of a medical device, the procedure of which is approved by the registration authority, or a notice of refusal to carry out the state registration of the medical device, indicating the reasons for the refusal.

25. Receipt by the registration authority of the opinion as to the impossibility to carry out clinical trials of the medical device from the expert institution shall substantiate the decision taken as to the refusal to carry out state registration.

26. With the exception of medical devices of potential use risk class 1 and medical devices for in vitro diagnostics, the clinical trials of a medical device shall be conducted as part of the conformity assessment, the procedure of which shall be approved by the Ministry of Health of the Russian Federation.

With the exception of medical devices of the potential use risk class 1 and medical devices for in vitro diagnostics, the clinical trials of a medical device shall be conducted based on the permit to conduct clinical trials issued by the registration authority, as well as the conclusion on the ethical substantiation of the conduct of clinical trials issued by the ethics council of the Ministry of Health of the Russian Federation, in cases established by these Rules.

The composition of this ethics council and the regulation on it shall be approved by the Ministry of Health of the Russian Federation.

Clinical trials of a medical device shall be carried out in medical institutions that meet the requirements approved by the Ministry of Health of the Russian Federation. The registration authority establishes the conformity of medical institutions with these requirements in accordance with the procedure established by the aforementioned Ministry.

27. A list of the medical institutions with the right to conduct clinical trials of medical devices, and the registry of issued permits to conduct clinical trials of medical devices, shall be published and posted by the registration authority through the procedure established by such registration authority, on its official site on the information and telecommunication network “Internet”.

28. When deciding whether to issue a permit to conduct clinical trials of a medical device, the registration authority shall decide on the suspension of the state registration of the medical device until the day when the registration authority decides to resume the state registration of the medical device, in accordance with paragraph 30 of these Rules.

29. The applicant shall notify the registration authority of the clinical trials of a medical device within 5 days from their commencement.

30. Upon completion of the clinical trials of the medical device the applicant submits an application to the registration authority for the resumption of the state registration of the medical device and clinical trials of the medical device, as well as the documents referenced in sub-paragraphs “b”“h”, “j” and “k” of paragraph 10 of these Rules, if changes are introduced to them based on clinical trial results of the medical device.

31. The registration authority shall take a decision on the renewal of the state registration of the medical device within 2 business days from receipt of the documents indicated in paragraph 30 of these Rules.

The decision to renew the state registration of the medical device is taken by the registration authority based on the results of the verification of the completeness and accuracy of the information contained in the application submitted to the registration authority for renewal of the state registration of the medical device and other documents specified in paragraph 30 of these Rules.

If these documents are not submitted in full or if unreliable data are found in them, as well as if the documents submitted are drawn up in a foreign language without translation into Russian attested through the established procedure, the registration authority shall submit (shall send as registered mail with notification of delivery or as soft copy signed with an electronic signature, or in electronic form via telecommunication channels) to the applicant a decision on the return of the application for renewal of the state registration of the medical device enclosing the aforementioned documents and giving the reasons serving as justification for the return. At the same time, the registration authority informs the applicant of the possibility of resubmitting an application for renewal of the state registration of the medical device enclosing the updated documents.

32. At Stage II of the expert evaluation of the quality, efficiency and safety of the medical device, the registration authority shall send the findings of the clinical trials of the medical device, which were submitted by the applicant to the expert institution within 2 business days from the day of the decision on the renewal of the state registration of the medical device on the basis of the assignment to conduct an expert evaluation of the quality, efficiency and safety of the medical device given in accordance with paragraph 20 of these Rules.

33. The expert institution shall carry out an expert evaluation of the completeness and findings of the conducted trials and studies within 10 business days following the day of the receipt of the documents mentioned in paragraph 32 of these Rules, and shall form and send an opinion on the findings of the expert evaluation of the quality, efficiency and safety of the medical device, the format of which is approved by the Ministry of Health of the Russian Federation.

34. Within a period not exceeding 10 business days following the day of the receipt of the opinion indicated in paragraph 33 of these Rules, the registration authority shall perform the following activities:

a) assessment of the conclusion to determine its conformity with the assignment for performing an expert evaluation of the quality, efficiency and safety of the medical device. If any discrepancy of the expert institution’s conclusion with the specified assignment is established, such conclusion shall be returned to the expert institution for finalisation, the term of which is not more than 2 business days from the day the expert institution received the returned conclusion;

b) making a decision on the state registration of the medical device or the refusal to carry out the state registration of the medical device, which is taken on the order of the registration authority, and notification of the applicant of the decision taken;

c) issue and delivery (despatch as registered mail with notification of delivery or as soft copy signed by electronic signature or transmission in electronic form via telecommunication channels) of the registration certificate or a notice of the refusal to carry out the state registration of the medical device to the applicant indicating the reasons for the refusal.

35. The grounds for the registering authority to take the decision on refusing to carry out the state registration of the medical device are:

a) receipt of a conclusion from the expert institution on the findings of the expert evaluation of the quality, efficiency and safety of the medical device, which suggests that the quality and/or efficiency and/or safety of the medical device being registered are not confirmed by data obtained and/or that the risk of harm to the health of citizens and medical professionals due to using the medical device exceeds the efficiency of its operation;

b) Based on the results of the state control over the circulation of medical devices, identification by the registration authority of inconsistencies of the data on the efficiency and safety of the medical device with the data on the medical device contained in the application for registration and the documents specified in paragraph 10 of these Rules.

36. The registration authority shall enter the data on the registered medical device in the state registry in accordance with the procedures set forth in Decree No. 615 by the Government of the Russian Federation dated June 19, 2012 within 1 business day from taking the decision on the state registration of the medical device.

37. Amendments to the documents contained in the registration dossier that do not require the expert evaluation of the quality, efficiency and safety of the medical device include:

a) change in the information on the applicant, including information:

on the restructuring of the legal entity;

on the change of the name of the legal entity (full and (if available) abbreviated name, including the company name), address of its location;

on the change of the surname, first name and (if applicable) patronymic, address of the place of residence of the individual entrepreneur and the details of the document proving his/her identity;

b) change in the information on the person in whose name the registration certificate for the medical device may be issued, including information:

on the restructuring of the legal entity;

on the change of the name of the legal entity (full and (if available) abbreviated name, including the company name), address of its location or the surname, first name and (if applicable) patronymic, address of the place of residence of the individual entrepreneur;

c) change in the address of the place of the production (manufacturing) of the medical device;

d) change of the name of the medical device if the properties and characteristics that affect the quality, efficiency and safety of the medical device have not changed or its properties and characteristics are being improved, preserving the same functionality and (or) the principle of its operation, providing for:

adding (excluding) the medical device’s accessories or change in their name;

indication, modification and exclusion of a trademark and other means for the individualisation of the medical device;

change in the number of units of the medical device or its components or component parts specified in the annex to the registration certificate;

indication or exclusion of design versions (models) of the medical device;

change of labelling and (or) packaging of the medical device;

e) change in the validity terms of the documents contained in the registration dossier by the producer (manufacturer) of the medical device;

f) change in the information on the authorised representative of the producer (manufacturer) of the medical device.

38. To have the documents contained in the registration dossier amended with the changes specified in paragraph 37 of these Rules, the applicant shall submit (send) to the registration authority no later than within 30 business days following the day of making the appropriate amendments:

a) an application for amending the documents contained in the registration dossier (hereinafter the application for making amendments), carried out in accordance with paragraph 9 of these Rules;

b) a copy of the document confirming the authority of the authorised representative of the manufacturer (producer);

c) documents and information on the relevant changes, including the documents confirming the amendments mentioned in subparagraphs “a” – “c” of paragraph 37 of these Rules, as well as in the event of a change in the name of the medical device:

information on the regulatory documentation for the medical device;

technical documentation of the producer (manufacturer) for the medical device provided in accordance with the new name of the medical device;

operational documentation of the producer (manufacturer) for the medical device (including the user manual or the operations manual of the medical device) provided in accordance with the new name of the medical device;

photographic images of the general configuration of the medical device together with the accessories needed for the intended application (in size at least 18 centimetres in length and 24 centimetres in width);

d) documents on the manufacturer and (or) organisations conducting technical tests, toxicity studies, clinical trials (results of relevant tests) confirming that making the aforementioned changes does not entail changes in the properties and characteristics affecting the quality, efficiency and safety of the medical device or improve the properties and characteristics preserving the same functional purpose and (or) the principle of the operation of the medical device;

e) original of the registration certificate (duplicate);

f) list of documents;

39. Amendments to the documents specified in subparagraphs “c” and “d” of paragraph 10 of these Rules (except for the instances referred to in paragraph “d” of paragraph 37 of these Rules) are made based on the results of the expert evaluation of the quality, efficiency and safety of the medical device carried out as per the procedure similar to that for evaluating the quality, efficiency and safety of the medical device for the purpose of its state registration in accordance with paragraph 21 of these Rules, if according to the results of the verification of the completeness and reliability of the information contained in the submitted documents the registration authority has established that making the aforementioned changes entails a change in the properties and characteristics affecting the quality, efficiency and safety of the medical device, or improves its properties and characteristics while preserving the functionality and (or) the principle of the operation of the medical device.

40. If the documents provided by paragraph 38 of these Rules are drawn up in a foreign language, they shall be submitted with a duly certified translation into Russian.

41. The registration authority shall accept the application for making changes and the documents referred to in paragraph 38 of these Rules, according to the list of contents, a copy of which is marked with the receipt date of the application and documents on the date of receipt, and shall be given to the applicant or sent to it as registered mail with notification of delivery or as soft copy signed with an electronic signature or in electronic form via telecommunication channels.

42. The registration authority may not require the applicant to submit documents that are not provided for in paragraph 38 of these Rules.

43. Within 5 business days from the receipt of the application for making changes and the documents required by paragraph 38 of these Rules, the registration authority shall verify the completeness and accuracy of the information contained in them, in particular, by comparing such information with the information presented by way of inter-departmental information exchange.

44. If the documents listed in accordance with subparagraph “b” – “f” of paragraph 38 of these Rules are not attached to the application for making amendments, and/or the application for making amendments provides unreliable information or the documents stipulated by paragraph 38 of these Rules, are not submitted in full, the registration authority shall give the applicant a notice of the need to rectify the identified irregularities and/or to submit the missing documents within 30 days, or send this notice as soft copy signed by electronic signature or in electronic form via telecommunication channels, or as registered mail with notification of delivery.

45. Within 3 business days from the day of submitting a duly drawn up application for making changes and a full set of the documents provided for by paragraph 38 of these Rules, the registration authority shall decide on consideration of the aforementioned application and the documents or (if they do not comply with the items of paragraph 38 of these Rules) on their return accompanied by a reasoned justification for their return.

46. If the identified irregularities have not been eliminated, and/or the missing documents have not been provided within 30 days, the registration authority shall take the decision to return the application to make amendments and the documents stipulated by paragraph 38 of these Rules, with a reasoned justification for their return.

47. Changes to the documents contained in the registration dossier that do not require an expert evaluation of the quality, efficiency and safety of the medical device are introduced by the registration authority within a period not exceeding 15 business days following the date of taking the decision to consider the application to make amendments and the documents stipulated by paragraph 38 of these Rules.

Changes to the documents contained in the registration dossier that require an expert evaluation of the quality, efficiency and safety of the medical device are introduced by the registration authority within a period not exceeding 35 business days following the date of taking the decision to consider the application to make amendments and the documents stipulated by paragraph 38 of these Rules.

48. The period for taking the decision by the registration authority to amend the documents contained in the registration dossier shall be calculated from the date of receipt by the registration authority of the duly issued application to make amendments and a full set of the documents envisaged by paragraph 38 of these Rules.

49. If amendments are made to the documents contained in the registration dossier, the registration authority shall undertake the following activities:

a) take the decision to amend the documents contained in the registration dossier which is issued by order of the registration authority;

b) give the expert institution an assignment to conduct an expert evaluation of the quality, efficiency and safety of the medical device and assessment of the conclusion made by the expert institution to determine the compliance with its assignment to conduct an expert evaluation of the quality, efficiency and safety of the medical device (in the instance established by paragraph 39 of these Rules). If any discrepancy of the expert institution’s conclusion with the specified assignment is established, such conclusion shall be returned to the expert institution for finalisation, the term of which is not more than 2 business days from the day the expert institution received the returned conclusion;

c) a written notification sent to the applicant about the decision taken as registered mail with notification of delivery or as soft copy signed with an electronic signature, or in electronic form via telecommunication channels enclosing the renewed registration certificate (in the event of making changes in it) and the previously issued registration certificate with an indication of its invalidity (indicating the date).

49(1). The grounds for the expert institution issuing a conclusion for not being able to introduce changes to the documents provided for in subparagraphs “c” and “d” of paragraph 10 of these Rules are:

a) unreliability of the submitted information justifying the introduction of the changes, including those identified by the registration authority according to the results of state control over the circulation of medical devices;

b) lack of information in the documents submitted by the applicant confirming that the changes made in the documents contained in the registration dossier do not entail a change in the properties and characteristics affecting the quality, efficiency and safety of the medical device, or improve the properties and characteristics while preserving the functionality and (or) the principle of operation of the medical device.

49(2). The registration authority takes the decision as to whether it is possible (impossible) to make changes to the documents contained in the registration dossier within 2 business days from the date of receipt of the expert institution’s opinion and sends notification to the applicant of the decision as registered mail with notification of delivery or as soft copy signed with an electronic signature or in electronic form via telecommunication channels.

The reason for taking the decision to refuse to amend the documents contained in the registration dossier is the receipt of a conclusion by the registration authority from the expert institution that it is impossible to amend the documents contained in the registration dossier of the medical device.

 

51. Within 1 business day after taking the decision to amend the documents contained in the registration dossier, the appropriate information is entered in the state register in accordance with the procedures set forth in Decree No. 615 of the Government of the Russian Federation dated June 19, 2012.

52. In the event of losing the registration certificate or damage to it, the applicant has the right to apply to the registration authority to file an application for having a duplicate registration certificate (hereinafter referred to as the application for the provision of a duplicate).

In the event of damage to the registration certificate, the damaged registration certificate shall be attached to the application for a duplicate.

53. Within 7 business days from the receipt of the documents listed in paragraph 52 of these Rules, the registration authority shall issue a duplicate registration certificate on the registration certificate form marked “duplicate” and “original registration certificate is deemed invalid” and shall deliver such duplicate to the applicant or send it as registered mail with notification of delivery.

54. The registration authority shall create a registration dossier comprising of the following documents:

a) the registration application and the documents stipulated by paragraph 10 of these Rules, the application for renewal of the state registration of the medical device, requests and documents specified in paragraphs 21(1) and 30 of these Rules, the application for making changes as stipulated by paragraph 38 of these Rules as well as the application for a duplicate;

b) a copy of the assignment for performing an expert evaluation of the quality, efficiency and safety of the medical device duly issued by the registration authority;

c) a copy of the permit issued by the registration authority to conduct clinical trials of the medical device;

d) conclusions issued by the expert institution when conducting an expert evaluation of the quality, efficiency and safety of the medical device;

e) copies of the orders issued by the registration authority;

f) a copy of the registration certificate or notices issued by the registration authority;

g) a copy of the duplicate registration certificate issued by the registration authority.

55(1). The grounds for the expert institution issuing a conclusion for not being able to introduce changes to the documents provided for in subparagraphs “c” and “d” of paragraph 10 of these Rules are:

a) inaccuracy of any information justifying the introduction of changes;

b) lack of evidence to support the consistent functionality and/or the principle of operation of the medical device in connection with the amendments introduced to the documentation.

55(2). The registration dossier is stored by the registration authority in accordance with the legislation of the Russian Federation on archives.

56. The registration certificate shall include the following information:

a) the name of the medical device (with the accessories required for operation of the medical device as intended);

b) the medical device’s state registration date and its registration number;

c) with respect to the legal entity in whose name the registration certificate was issued, the full and (if applicable) abbreviated name, including the company name, legal form of incorporation of the legal entity and the address of its location or surname, first name and patronymic (if applicable), address of the place of residence of the individual entrepreneur;

d) with respect to the producer (manufacturer), the full and (if applicable) the abbreviated name, including the corporate name, legal form and the address of location or surname, first name and patronymic (if applicable), address of the place of residence of the individual entrepreneur;

e) place of manufacture of the medical device:

f) registration dossier number;

g) the potential risk class of the medical device’s operation in accordance with the nomenclature classification of medical devices approved by the Ministry of Health of the Russian Federation;

h) the code of All-Russian Classification of Products by economic activity;

57. The registration authority shall decide to cancel the state registration of a medical device in the following cases:

a) the applicant submits an application for cancellation of the state registration of the medical device;

b) announcement of a judgment as to the violation of the rightholders’ rights to the deliverables of intellectual property and similar means of individualisation when medical devices are in circulation;

c) provision by the federal executive authority authorised by the Government of the Russian Federation of information confirming that there are facts and circumstances threatening the life and health of citizens and medical professionals when operating and using the medical devices based on the findings of its governmental control over the circulation of medical devices.

d) identification by the registration authority of unreliable information in the documents contained in the registration dossier submitted by the applicant and affecting the results of the expert evaluation of the quality, efficiency and safety of the medical device according to the results of the governmental control over the circulation of medical devices;

e) receipt by the registration authority of the conclusions from the expert institution that the instrument, apparatus, device, equipment, material and other products contained in the state register may not be used for medical purposes in their functional purpose and/or principle of operation and are not medical devices. The conclusion shall be submitted (sent) by the expert institution to the registration authority within 10 business days from the date of receipt by the expert institution of the relevant task of the registration authority enclosing the documents of the registration dossier.

58. The registration authority shall publish information related to the state registration of the medical device, making amendments to the documents contained in the registration dossier and issue of a duplicate registration certificate on its official website on the information and telecommunications network “Internet”.

58(1). The expert institution gives advice on the procedures related to the state registration of medical devices in accordance with the procedure established by the registration authority.

59. Decisions and actions (inactivity) of the registration authority that have entailed the violation of the rights of a legal entity, an individual entrepreneur, as well as the opinion of the expert institution based on the findings of expert evaluations conducted by it in accordance with these Expert Evaluation rules, may be appealed by the applicant in the manner prescribed by the legislation of the Russian Federation.

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