post-bg-414
calendary January 16, 2025

Order No. 299 by the Ministry of Health of the Russian Federation

“On amendments to the Rules for the Marketing Authorisation of Medical Devices”

 

The Government of the Russian Federation hereby orders the following:

  1. Approve amendments, as per the attachment, to the Rules for the Marketing Authorisation of Medical Devices, as previously approved by Order of the Government of the Russian Federation No. 1416 dated 27 December, 2012 “On approval of the Rules for the Marketing Authorisation of Medical Devices” (Legislative Corpus of the Russian Federation, 2013, N 1, Art. 14; N 43, Art. 5556; 2014, N 30, Art. 4310; 2017, N 8, Art. 1233; 2018, N 24, Art. 3523).
  2. This order comes into full force on the day of its official publication.
Head of the Government
of the Russian Federation
M. Mishustin

APPROVED
by Order of the Government
of the Russian Federation
dated 18 March 2020, no. 299

Amendments
to the Rules for the Marketing Authorisation
of medical devices

  1. Paragraph 5 after the first sentence to be expanded by adding the following sentence:

“Please refer to paragraphs 57–57 20 for the specific procedure for the Marketing Authorisation of medical devices with a low risk potential associated with their usage, for which such specific procedure is provided; please refer to the list of such devices in the related Attachment (hereinafter the List).

  1. For paragraph 8 and the first sentence of paragraph 10, the wording shall be amended as follows: add “(except for the medical devices included in the List)” after “For the Marketing Authorisation of medical devices”.
  2. The first sentence of paragraph 19, the wording shall be amended as follows: add “(except for the medical devices included in the List)” after “The Marketing Authorisation of medical devices”.
  3. For paragraph 20, the wording shall be amended as follows: add (except for the medical devices included in the List)” after “about the start of the Marketing Authorisation Procedure”/
  4. For sub-paragraph “а” of paragraph 21 add “and also medical devices included in the List” after “for in-vitro diagnostics”.
  5. For the second sentence of paragraph 26, add “and also medical devices included in the List” after “for in-vitro diagnostics”.
  6. For sub-paragraphs “b” and “c” of paragraph 34, add “(except for the medical devices included in the List)”.
  7. For the first sentence of paragraph 35, the wording shall be amended as follows: add “(except for the medical devices included in the List)” after “the medical device”.
  8. Paragraph 57 shall be amended with sub-paragraphs “f”–“j” as follows:
  9. f) if substantiated by the reasons stated in paragraph 5717 of the Rules (concerning medical devices included in the List);
  10. g) when the Applicant fails to provide documentation listed in paragraph 5710 of the Rules (concerning medical devices included in the List);
  11. h) when the Registration Authority has twice decided to return the documents provided in accordance with paragraph 5713 of the Rules (concerning medical devices included in the List);
  12. i) when the Applicant fails to provide documentation listed in paragraph 5710 of the Rules within 50 working days after the Registration Authority returned the documents submitted, in accordance with paragraph 5713 of the Rules (concerning medical devices included in the List);
  13. j) exclusion of the medical device concerned from the List.
  14. Add paragraphs 571 – 5720 stating the following:

57 1. Marketing Authorisation of the medical device included in the List has to be given once for each one article of the medical device by the same single manufacturer (producer).

57 2. In order to obtain Marketing Authorisation for the medical device included in the List, the Applicant shall provide or submit to the Registration Authority the related application and support it with the following documentation:

  1. a) a copy of the document confirming the authority of the manufacturer's (producer's) authorised representative
  2. b) technical documentation of the manufacturer (producer) for the medical device;
  3. c) operational documentation of the manufacturer (producer) for the medical device, including the user manual or the operations manual for the medical device;
  4. d) photographic images of the general configuration of the medical device together with the accessories needed for its intended application (minimum 18 x 24 cm);
  5. e) list of documents.

57 3. If the documents referred to in paragraph 572 and 57 10 of the Rules are drawn up in a foreign language, they shall be presented with a duly certified translation into Russian.

57 4. The registration application and the documents referred to in paragraph 57 2 and 57 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 list of enclosures, or as soft copy signed by electronic signature.

The registration authority shall receive the registration application and the aforementioned documents, according to the list of contents, a copy of which marked with the receipt date of the application and documents 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 on the date of receipt.

57 5. The Registration Authority shall not require the applicant to indicate any information that is not provided for by paragraph 9 of the Rules, or submit documents not provided for by paragraphs 57 2 and 57 10 of the Rules.

57 6. Concerning the medical device included in the List, the Registration Authority shall within 3 working days upon receipt of the registration application and the documents required by paragraph 57 2 of these Rules 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.

57 7. If the registration application for the medical device included in the List is made in violation of the provisions of paragraph 9 of these Rules, and (or) the application provides false information, or documents required by paragraph 57 2 of the Rules have not been provided in full, the Registration Authority shall give the applicant notice to rectify the discrepancies identified within a 5 working day 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.

57 8. Concerning the medical device included in the list, the Registration Authority shall, within 5 working days upon provision of the complete set of the duly worded registration application and supporting documentation as required by paragraph 57 2 of the Rules, and also in the event of the rectification of any related violations or discrepancies within the term stated in paragraph 57 7 of the Rules, and/or in the event of the prompt submission of any missing documents, carry out the following measures:

а) make a related decision on the Marketing Authorisation of the medical device concerned, and issue the appropriate order by the Registration Authority;

  1. b) issue and deliver (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 to the applicant;

57 9. Concerning the medical device included in the List, if the discrepancies identified have not been rectified and/or the missing documents have not been provided within the term provided in paragraph 57 7 of the Rules, then the Registration Authority shall make a decision to return the registration application and documents required by paragraph 572 of the Rules, and attach a note substantiating the reasons for such return.

If the medical device is not included in the List, and (or) the requirements of paragraph 57 1 of the Rules are violated, then the Registration Authority shall make a decision to return the registration application and documents required by paragraph 572 of the Rules, and attach a note substantiating the reasons for such return.

57 10. Within 150 working days upon obtaining the Marketing Authorisation for the medical device included in the List, the Applicant shall submit the following documents to the Registration Authority:

  1. a) a copy of the document confirming the authority of the manufacturer's (producer's) authorised representative
  2. b) information on the regulatory documentation for the medical device;
  3. c) any documents mentioned in sub-paragraphs b), c) and d) of paragraph 572 of the Rules (in the event when such documents were amended on the basis of the results of any tests or trials performed for the medical device concerned);
  4. d) documents confirming the results of technical tests performed for the medical device concerned, which shall be issued by the Federal State Budgetary Institution “Russian Institute for Research, Design and Testing of Medical Devices and Equipment” of the Federal Service for Surveillance in Healthcare (hereinafter the Institution);
  5. e) documents confirming the findings of toxicological studies of a medical device, the use of which implies contact with the human body, which have to be issued by the Institution;
  6. f) 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 Healthcare of the Russian Federation), which have to be issued by the Institution.
  7. g) documents confirming the results of any clinical trials of the medical device in question performed in the medical organization which is the part of the State Healthcare system and complies with the requirements approved by the Ministry of Healthcare of the Russian Federation;
  8. h) 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;
  9. i) original copy of the Marketing Authorisation Certificate;
  10. j) list of documents.

57 11. Within 5 working days following receipt of the registration application and the documents required by paragraph 57 10 of the Rules, the Registration Authority shall verify the completeness and accuracy of the information therein contained, in particular by comparing such information with the information contained in the Marketing Authorisation Certificate issued in accordance with the Rules for the medical device included in the List, and with the information presented by way of an inter-departmental information exchange.

If the documents concerned have not been provided in full, the Registration Authority shall give the applicant notice to rectify the discrepancies identified and/or to submit the missing documents within a 30-day period, or shall 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 sent by registered mail, the Notice is considered received after 10 working days following the date of sending the notice.

57 12. Within 3 working days following the date of submission of the full set of documents required by paragraph 57 10 of these Rules, and also if the discrepancies identified have been rectified and/or the documents required by paragraph 57 10 of these Rules are submitted within the 30-day period, the Registration Authority shall make a decision to start the expert evaluation of the quality, efficiency and safety of the medical device included in the List.

57 13. If the discrepancies identified 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 57 10 of the Rules, with a note substantiating the reasons for such action.

57 14. 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 Expert Institution within 3 working days following the date of taking the decision as to the start of such expert evaluation.

57 15. The procedure for the expert evaluation of the efficiency, safety and quality of the medical device included in the List is described in sub-paragraph b) of paragraph 21 of the Rules.

57 16. Within a period not exceeding 10 working 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:

  1. a) assessment of the opinion provided by the Expert Institution in order 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 opinion with the specified assignment is established, such conclusion shall be returned to the expert institution for finalisation, the term of which is no more than 2 working days following the day the expert institution received the returned opinion;
  2. b) make a decision on the confirmation of the Marketing Authorisation for the medical device included in the List, with subsequent issue and delivery of the notification of the decision to the Applicant, together with the re-issued Marketing Authorisation Certificate (which documents shall be despatched as registered mail with notification of delivery or as soft copy signed by electronic signature or transmission in electronic form via telecommunication channels);
  3. c) or make a decision on revoking the Marketing Authorisation for the medical device included in the List, with subsequent issue of the Order of the Registering Authority and withdrawal of the previously issued Marketing Authorisation Certificate, of which action the Applicant shall be duly notified.

57 17. Grounds for the Registering Authority to make a decision on revoking the Marketing Authorisation of the medical device are as follows:

  1. a) an opinion drawn up by the Expert Institution, based on the results of the expert evaluation of the quality, efficiency and safety of the medical device, stating that the quality and/or efficiency and/or safety of the medical device in question are not supported by the available data, and/or an opinion stating that the risk of harm to the patient and medical professionals caused by the use of the medical device in question outweighs the beneficial effect of its usage, and/or an opinion stating that the medical device in question does not comply with the applicable regulations, technical documentation or operational instructions of the manufacturer (producer), and/or an opinion stating that there is no available solid proof of the safety of the said medical device;
  2. b) based on the results of state monitoring of 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 572 and 5710 of the Rules.

57 18. Any amendment to the documents constituting the registration file for the medical device included in the List may be made only after a decision confirming the Marketing Authorisation of the said medical device, in accordance with paragraphs 37–49 2, 51 and 55 1 of the Rules/

57 19. If a duplicate copy of the Marketing Authorisation Certificate is required for the medical device included in the List, for which the Marketing Authorisation was confirmed, this has to be issued as per the procedure set forth in paragraphs 52 and 53 of the Rules.

57 20. The Registration Authority has to compile a registration file for the medical device included in the List on the basis of the following documents:

  1. a) the registration application and the documents stipulated by paragraph 572 and 5710 of the Rules, requests and documents specified in paragraph 21 1 of the Rules, the application for amendments as stipulated by paragraph 38 of these Rules as well as the application for a duplicate copy;
  2. b) a copy of the assignment from the Registration Authority for performing an expert evaluation of the quality, efficiency and safety of the medical device duly issued by the Registration Authority;
  3. c) opinions issued by the expert institution when conducting an expert evaluation of the quality, efficiency and safety of the medical device;
  4. d) copies of the orders issued by the Registration Authority;
  5. e) a copy of the registration certificate or notices issued by the Registration Authority;
  6. f) a copy of the duplicate registration certificate issued by the Registration Authority”.
  7. Amend with Appendix containing the following:

LIST of medical devices with low risk of usage regarding which specific rules for marketing authorization apply risk of usage regarding which specific rules for marketing authorization apply

  Type Name of device

 

1.

 

104010

 

Isolating overall

2. 122540 Gloves for manual examination/interventions, made of natural hevea latex, non-powdered, non-sterile
3. 122560 Gloves for manual examination/interventions, made of natural hevea latex, powdered
4. 129350 Surgical gown, single use
5. 129380 Surgical gown, reusable
6. 129870 Isolating gown, reusable
7. 129880 Isolating gown, single use
8. 132380 Facial mask for respiratory protection, reusable
9. 139350 Gloves for manual examination/interventions, made of polychloroprene, non-powdered
10. 139360 Gloves for manual examination/interventions, made of polychloroprene, powdered
11. 141650 Overshoes non-conductive, non-sterile
12. 157010 Patient’s gown, single use
13. 157240 Patient’s gown, reusable
14. 164050 Gown for interventions, single use
15. 164070 Gown for interventions, reusable
16. 180770 Breathing mask, general purpose
17. 181360 Surgical isolating overall
18. 181520 Surgical mask, reusable
19. 181830 Surgical breathing mask
20. 182450 Surgical mask, single use
21. 185830 Gloves for manual examination/interventions, made of nitrile rubber, non-powdered, non-sterile
22. 185850 Gloves for manual examination/interventions, made of nitrile rubber, powdered
23. 188380 Surgical overall, cuffed
24. 205280 Gloves for manual examination/interventions, made of vinyl, non-powdered
25. 205290 Gloves for manual examination/interventions, made of vinyl, powdered
26. 248320 Surgical overall, single use, non-sterile
27. 269290 Overshoes, watertight
28. 293810 Overshoes, conductive, non-sterile
29. 298450 Gloves for manual examination/interventions, made of guayule latex, non-powdered
30. 311720 Gloves for manual examination/interventions, made of ethylene vinyl acetate, non-powdered, non-sterile
31. 320790 Gloves for manual examination/interventions, made of nitrile rubber, non-powdered, with anti-bacterial properties
32. 321530 Gloves for manual examination/interventions, made of polyisoprene, non-powdered
33. 332470 Set of overalls for surgery/examination
34. 349230 Gloves for manual examination/interventions, made of polyisoprene, powdered
35. 351490 Gloves for manual examination/interventions, made of natural hevea latex, non-powdered, non-sterile, with anti-bacterial properties
36. 367580 Facial mask for respiratory protection, single use
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