From March 1, 2022, a new procedure for maintaining the state register of medical devices and organizations engaged in their production and manufacture is introduced.
Decree of the Government of the Russian Federation of September 30, 2021 N 1650 “On approval of the Rules for maintaining the state register of medical devices and organizations (individual entrepreneurs) engaged in the production and manufacture of medical devices, on amending the list of regulatory legal acts and groups of regulatory legal acts of the Government of the Russian Federation, regulatory legal acts, individual provisions of regulatory legal acts and groups of regulatory legal acts of federal executive bodies, legal acts, individual provisions of legal acts, groups of legal acts of executive and administrative bodies of state power of the RSFSR and the USSR, decisions of the State Commission on Radio Frequencies containing mandatory requirements, in respect of which the provisions of Parts 1, 2 and 3 of Article 15 of the Federal Law “On Mandatory Requirements in the Russian Federation” and also on the recognition of certain acts of the Government of the Russian Federation as invalid ”
It was established that the register, among other things, must contain photographic images of a general view of a medical device and an electronic carrier and software interface, as well as electronic images of the manufacturer’s (manufacturer’s) operational documentation for a medical device and a registration certificate for a medical device.
In addition, it is stipulated that an extract from the register is provided in the form of an electronic document, signed with an enhanced qualified electronic signature of an authorized official of Roszdravnadzor of Russia and sent to the interested person by mail or the official website of Roszdravnadzor on the Internet or a single portal of state services.
A number of regulations have been brought in line with the amendments, and certain acts of the Government of the Russian Federation have been declared invalid.
This Resolution is valid until March 1, 2028.