GOVERNMENT OF THE RUSSIAN FEDERATION

RESOLUTION

of April 3, 2020 N 430

ABOUT FEATURES

HANDLING OF MEDICAL DEVICES, INCLUDING STATE

REGISTRATION OF A SERIES (LOTS) OF A MEDICAL DEVICE

List of changing documents

(as amended by Resolutions of the Government of the Russian Federation dated 02.06.2020 N 804,

from 13.11.2020 N 1826, from 06.03.2021 N 337, from 10.12.2021 N 2250,

from 28.12.2021 N 2506)

In accordance with Part 5.1 of Article 38 of the Federal Law "On the Basics of Health Protection of Citizens in the Russian Federation" and Clause 2 of Part 1 of Article 17 of the Federal Law "On Amendments to Certain Legislative Acts of the Russian Federation on the Prevention and Elimination of Emergencies", the Government of the Russian Federation decides :

1. To approve the attached features of the circulation of medical devices, including the state registration of a series (batch) of a medical device.

2. This resolution comes into force from the date of its official publication and is valid until January 1, 2025.

(as amended by the Resolutions of the Government of the Russian Federation of 13.11.2020 N 1826, of 10.12.2021 N 2250)

Prime Minister

Russian Federation

1. MISHUSTIN

    

    

    

    

   Approved

   government decree

   Russian Federation

   of April 3, 2020 N 430

    

   PECULIARITIES

   HANDLING OF MEDICAL DEVICES, INCLUDING STATE

   REGISTRATION OF A SERIES (LOTS) OF A MEDICAL DEVICE

    

   1. This document applies to the circulation of medical devices that are intended for use in military operations, emergency situations, emergency prevention, prevention and treatment of diseases that pose a danger to others, diseases and injuries resulting from exposure to adverse chemical, biological, radiation factors, according to the list according to Appendix No. 1 (hereinafter - the medical device), including the state registration of a series (batch) of a medical device.

   (as amended by the Decree of the Government of the Russian Federation of 02.06.2020 N 804)

   ConsultantPlus: note.

   Registration certificates for a series (batch) of a medical device according to the list according to Appendix 1, issued before 12/22/2021, are valid until 01/01/2025 without replacing the registration certificate (Decree of the Government of the Russian Federation of 12/10/2021 N 2250).

    

   2. A registration certificate for a series (batch) of a medical device is issued with a validity period until January 1, 2025.

   (as amended by the Resolutions of the Government of the Russian Federation of 13.11.2020 N 1826, of 10.12.2021 N 2250)

   3. For state registration of a medical device, a developer, manufacturer (manufacturer) of a medical device, an authorized representative of a manufacturer (manufacturer) or a person importing a medical device into the Russian Federation for the purpose of its state registration (hereinafter referred to as the applicant) shall submit or send to the federal state budget institutions under the jurisdiction of the Federal Service for Surveillance in Healthcare (hereinafter referred to as the expert institution), in the form of an electronic document and (or) on paper:

   an application for state registration of a medical device in accordance with the requirements of paragraph 9 of the Rules for state registration of medical devices, approved by the Government of the Russian Federation dated December 27, 2012 N 1416 "On approval of the Rules for state registration of medical devices" (hereinafter - the Registration Rules);

    

   a copy of the document confirming the authority of the authorized representative of the manufacturer (manufacturer) (if any);

   documents confirming the belonging of the series (batch) of the medical device to the applicant on legal grounds;

   manufacturer's (manufacturer's) technical documentation for a medical device (if any);

   manufacturer's (manufacturer's) operational documentation for a medical device that meets the requirements approved by the Ministry of Health of the Russian Federation;

   photographic images of a general view of a medical device together with accessories necessary for the intended use of the medical device (at least 18 by 24 centimeters in size);

   documents confirming the results of technical tests of a medical device, toxicological studies of a medical device, the use of which involves contact with the human body, clinical trials of a medical device conducted in accordance with a standard test program depending on the type of medical device developed by an expert institution (hereinafter referred to as a standard program ), and published on the official websites of expert institutions in the information and telecommunications network "Internet" (as applicable). If tests (studies) are carried out in the Russian Federation according to a program different from the standard one, the expert institution determines the sufficiency of such studies (tests) for the purposes of state registration of a series (batch) of medical devices in accordance with this document;

   (as amended by the Decree of the Government of the Russian Federation of 02.06.2020 N 804)

   other documents characterizing the quality, effectiveness and safety of a medical device (if any);

   list of documents.

    

   If these documents are drawn up in a foreign language, they are submitted with a translation into Russian certified by the applicant.

   The requirements established by the Ministry of Health of the Russian Federation on the conformity assessment of medical devices in the form of technical tests, toxicological studies, clinical trials for the purpose of state registration of medical devices are not mandatory for testing (research) of medical devices included in the list. This provision shall apply until the elimination of the threat of an emergency or the elimination of an emergency. Medical devices that have not passed the specified conformity assessment are subject to re-registration in accordance with the legislation of the Russian Federation.

   4. The expert institution, within 3 working days from the date of receipt of the documents specified in paragraph 3 of this document, assesses their completeness, sufficiency and completeness, including the sufficiency of the volume of tests (studies) of medical devices for the purposes of state registration of a batch (batch) medical devices in accordance with this document, draws up an opinion on the possibility (impossibility) of state registration of a series (batch) of medical devices in the form established by the Ministry of Health of the Russian Federation for the purpose of examining the quality, effectiveness and safety of a medical device, and sends it to the Federal Service for Supervision in the field of health care.

   The documents submitted by the applicant in accordance with paragraph 3 of this document are attached to the conclusion of the expert institution.

   If the materials and information contained in the documents provided by the applicant provided for in paragraph 3 of this document are insufficient for the expert institution to issue an opinion, the expert institution, within 2 working days from the date of receipt of these documents, sends to the applicant by registered mail with a receipt acknowledgment or in the form of an electronic document , signed with an electronic signature, or in electronic form via telecommunication channels, a request for the submission of the necessary information, indicating the nature of the comments and the way to eliminate them (hereinafter - the request).

   (the paragraph was introduced by the Decree of the Government of the Russian Federation of 06/02/2020 N 804)

   The applicant is obliged to submit a response to the request of the expert institution within a period not exceeding 5 working days from the date of receipt of the request. The expert institution prepares an opinion within 2 working days from the date of receipt of a response to the request from the applicant.

   (the paragraph was introduced by the Decree of the Government of the Russian Federation of 06/02/2020 N 804)

    

   If the applicant fails to provide a response to the request after 5 working days, the expert institution prepares an opinion on the basis of the documents at its disposal.

   (the paragraph was introduced by the Decree of the Government of the Russian Federation of 06/02/2020 N 804)

   5. A conclusion on the impossibility of state registration of a series (batch) of medical devices is drawn up by an expert institution if there are the following grounds (one or more):

   a) there is no evidence of the compliance of the medical device with the requirements of the manufacturer's (manufacturer's) documentation;

   b) there is no evidence of the safety of the medical device;

   c) the quality, and (or) effectiveness, and (or) safety of the medical device is not confirmed by the received data;

   d) the risk of harm to the health of citizens and medical workers due to the use of a medical device exceeds the effectiveness of its use;

   e) the medical device is absent from the list provided for by Appendix No. 1 to this document;

   (as amended by the Decree of the Government of the Russian Federation of 02.06.2020 N 804)

   f) the documents specified in clause 3 of this document are not presented in full.

    

   6. Federal Service for Surveillance in Healthcare within 2 working days from the date of receipt of the opinion specified in paragraph 4 of these features:

   (as amended by the Decree of the Government of the Russian Federation of 02.06.2020 N 804)

   a) makes a decision on state registration of a series (batch) of a medical device, formalized by an order of the Federal Service for Surveillance in Healthcare, sends the applicant a registration certificate for a medical device by registered mail with a receipt acknowledgment or in the form of an electronic document signed with an electronic signature, or in electronic form via telecommunication channels, enters into the state register of medical devices and organizations (individual entrepreneurs) engaged in the production and manufacture of medical devices, information about the registered series (batch) of medical products);

   b) makes a decision to refuse state registration of a series (batch) of a medical device and sends a reasoned refusal to the applicant by registered mail with a receipt acknowledgment or in the form of an electronic document signed with an electronic signature, or in electronic form via telecommunication channels (in case of receipt of an opinion on the impossibility of state registration of a medical device).

   7. A registration certificate for a series (batch) of a medical device is drawn up in accordance with the requirements of clause 56 of the Registration Rules with an additional indication of its validity period, a series (batch) number of a medical device, serial numbers of medical devices (if any).

   7 (1). With regard to the medical devices specified in paragraphs 1 - 18 of Appendix No. 1 to this document, it is allowed to make changes to the name of the medical device in terms of changing the information about its serial number (if any), the series (batch) number, if others have not changed. information contained in the documents of the registration dossier.

   (Clause 7 (1) was introduced by the Decree of the Government of the Russian Federation of 02.06.2020 N 804)

   7 (2). To make the changes specified in clause 7 (1) of this document to the documents contained in the registration dossier, the applicant submits (sends) to the Federal Service for Surveillance in Healthcare:

   an application for amending the documents contained in the registration dossier (hereinafter referred to as an application for amending), drawn up in accordance with clause 9 of the Registration Rules;

   a copy of the document confirming the authority of the authorized representative of the manufacturer (manufacturer) (if any);

   documents confirming the belonging of the series (batch) of the medical device to the applicant on legal grounds;

   photographic images of a general view of a medical device together with accessories necessary for the intended use of the medical device (at least 18 by 24 centimeters in size);

   manufacturer's document confirming that the medical device with the declared serial numbers (if any), batch (batch) numbers is identical to the medical device originally registered in accordance with this document;

   original registration certificate;

   list of documents.

   If these documents are drawn up in a foreign language, they are submitted with a translation into Russian certified by the applicant.

   (Clause 7 (2) was introduced by the Decree of the Government of the Russian Federation of 02.06.2020 N 804)

    

   7 (3). The application for amendments and the documents provided for in clause 7 (2) of this document shall be submitted by the applicant to the Federal Service for Surveillance in Healthcare in hard copy directly or sent by registered mail with a return receipt and a list of attachments or in the form of an electronic document.

   The Federal Service for Surveillance in Healthcare accepts the application for amendments and the documents provided for in paragraph 7 (2) of this document, according to the inventory.

   (Clause 7 (3) was introduced by the Decree of the Government of the Russian Federation of 02.06.2020 N 804)

   7 (4). Within 3 working days from the date of receipt of the application for amendments and documents provided for in paragraph 7 (2) of this document, the Federal Service for Surveillance in Healthcare checks the completeness and reliability of the information contained therein and carries out:

   a) making a decision on amending the documents contained in the registration dossier, which is drawn up by order of the Federal Service for Surveillance in Healthcare, entering into the state register of medical devices and organizations (individual entrepreneurs) engaged in the production and manufacture of medical devices, relevant information or decisions on the return of the application for amendments and the documents provided for in paragraph 7 (2) of this document, with a reasoned justification of the reasons for the return;

   b) notification in writing of the applicant of the decision taken by registered mail with a receipt acknowledgment with the attachment of the reissued registration certificate (if changes are made to it) and the previously issued registration certificate with a mark of its invalidity (indicating the date).

   (Clause 7 (4) was introduced by the Decree of the Government of the Russian Federation of 02.06.2020 N 804)

   8. The Federal Service for Surveillance in Healthcare forms a registration dossier for a series (batch) of a medical device using the following documents:

   a) an application for state registration and documents provided for in paragraph 3 of this document, as well as an application for amendments and documents provided for in paragraph 7 (2) of this document;

   (as amended by the Decree of the Government of the Russian Federation of 02.06.2020 N 804)

   b) conclusion on the possibility (impossibility) of state registration of a series (batch) of a medical device;

   c) a decision on state registration of a series (batch) of a medical device, drawn up by an order of the Federal Service for Surveillance in Healthcare;

   d) a copy of the registration certificate and copies of notifications issued by the Federal Service for Surveillance in Healthcare.

   (as amended by the Decree of the Government of the Russian Federation of 02.06.2020 N 804)

   9. The state duty for the issuance of a registration certificate is paid in accordance with the legislation of the Russian Federation on taxes and fees.

   10. It is allowed to import into the Russian Federation without obtaining permission from the Federal Service for Surveillance in Healthcare of unregistered medical devices according to the list provided for in Appendix No. 1 to this document, in the amount necessary for testing (research), state registration and subsequent sale. This provision is valid until the elimination of the threat of an emergency and (or) the elimination of the emergency.

   (as amended by the Decree of the Government of the Russian Federation of 02.06.2020 N 804)

   It is allowed to import into the Russian Federation, sale, transportation, storage, use and disposal (destruction) of disposable medical devices not registered in the Russian Federation according to the list provided for in Appendix No. 1 to this document, without obtaining permission from the Federal Service for Surveillance in Healthcare, if the specified products are registered in the established order in the country of origin.

   (as amended by the Decree of the Government of the Russian Federation of 02.06.2020 N 804)

   The applicant is obliged, within 3 working days from the date of importation of unregistered medical devices into the Russian Federation, through the automated information system of the Federal Service for Supervision in Healthcare, information on the series (lots) of medical devices in accordance with Appendix No. 2 to this document.

   (as amended by the Resolutions of the Government of the Russian Federation of 06/02/2020 N 804, of 03/06/2021 N 337)

   Reusable medical devices imported into the Russian Federation that are not registered in accordance with this document, after January 1, 2025, are subject to destruction or removal from the territory of the Russian Federation.

   (as amended by the Resolutions of the Government of the Russian Federation of 13.11.2020 N 1826, of 10.12.2021 N 2250)

   The applicant weekly, until January 1, 2025, in respect of unregistered and registered in accordance with this document and with the Rules for the registration of medical devices specified in clauses 19 - 78 of Appendix No. health care information in accordance with Appendix No. 2 to this document on their implementation, on export from the territory of the Russian Federation or on destruction in accordance with this document.

   (as amended by Resolutions of the Government