Order of Russian Government 1826 dated 13th of November 2020 г

GOVERNMENT OF THE RUSSIAN FEDERATION

RESOLUTION

dated 13 November 2020 no. 1826

MOSCOW

On Amendments to Resolution of the Government of the Russian Federation dated 3 April 2020 no. 430

and on Replacing the Registration Certificate for a Series (Batch) of a Medical Device

The Government of the Russian Federation resolves to:

  1. Confirm the appended amendments made to Resolution of the Government of the Russian Federation dated 3 April 2020
  2. 430 “On Aspects of the Circulation of Medical Devices, including the Marketing Authorization of a Series (Batch) of a Medical Device” (Corpus of Legislation of the Russian Federation, 2020, no, 15, art. 2284:
  3. 23, art. 3667):
  4. It shall be established that:

а) the registration certificates for a series (batch) of a medical device intended to be used in the context of military operations, emergency situations, prevention of emergency situations, prevention and treatment of illnesses that constitute a danger to the wider public, and of illnesses and injuries received as a result of the effects of adverse chemical, biological and radiation factors, based on the list in accordance with Appendix no. 1 to Resolution of the Government of the Russian Federation dated 3 April 2020

  1. 430 “On Aspects of the Circulation of Medical Devices, including the Marketing Authorization of a Series (Batch) of a Medical Device” (hereinafter a Medical Device), issued as per the procedure set out by the above-mentioned Resolution until the entry into force of this

2

Resolution, are valid until 1 January 2022 and shall be replaced before 1 January 2021;

  1. b) replacement of the registration certificate for a series (batch) of a medical device that was issued before this Resolution entered into force shall be carried out without going through the procedure of the marketing authorization of this series (batch) on the basis of the declaration of the marketing authorization of the medical device provided by the developer or producer (manufacturer) of the medical device, the authorized representative of the producer (manufacturer) or entity importing the medical device into the Russian Federation with a view to its marketing authorization, to the Federal Service for Surveillance in Healthcare specifying the information stipulated by the Rules and Regulations for the Marketing Authorization of Medical Devices as confirmed by Resolution of the Government of the Russian Federation dated 27 December 2012 no. 1416 “On Confirming the Marketing Authorization of Medical Devices”, with the original of the registration certificated appended
  2. c) following the replacement of the registration certificate for a series (batch) of a medical device, the developer or producer (manufacturer) of the medical device, the authorized representative of the producer (manufacturer) of the medical device or the entity importing the medical device into the Russian Federation with a view to its marketing authorization, shall be issued by the Federal Service for Surveillance in Healthcare with a redrafted registration certificate for a series (batch) of a medical device as well as the previously issued registration certificate marked to show that it is now invalid (specifying the date when the registration certificate was redrafted) containing the appropriate entries in the State Register of Medical Devices and Organizations (Individual Entrepreneurs) Producing (Manufacturing) Medical Devices.

Chairman of the Government

of the Russian Federation                                                                                                                      M. Mishustin

CONFIRMATION

by Resolution of the Government of the Russian Federation

dated 13 November 2020 no. 1826

OF AMENDMENTS

made to Resolution of the Government of the Russian Federation dated 3 April 2020 no. 430

  

  1. In clause 2 the words “1 January 2021” are to be replaced with the words “1 January 2022”
  2. In clause 2 and throughout the text of clause 10 of Aspects of the Circulation of Medical Devices, including the Marketing Authorization of a Series (Batch) of a Medical Device as confirmed by the afore-mentioned Resolution, the words “1 January 2021” are to be replaced by the words “1 January 2022”.