As it can be seen from the updated version proposed by the Ministry of Health, the validity of the Registration Certificates will be extended until January 1, 2025 instead of January 1, 2022, and the holders should renew them before the deadline.
In addition, the list of medical devices to the simplified market entry procedure will be expanded from 360 to 447 items – it will include various consumables for oxygen systems, ventilators, artificial lung ventilation systems and oxygen support, nucleic acid sequencers, as well as disposable medical devices – gloves, gowns and protective shields.
As the Ministry of Health declares in its Explanatory Note, despite the introduction of registration under the Eurasian Economic Union rules from January 1, 2022, countries still have the right to establish their own standards for the circulation of medical devices in the event of emergencies, epidemics and mass spread of diseases. The Registration Certificates of 447 types of medical devices will be extended until January 1, 2025, and the simplified registration scheme will remain the same.
In connection with the spread of COVID-19, the Government of the Russian Federation in the spring of 2020 introduced a temporary procedure for the import, registration and circulation of medical products for fight against COVID-19. According to the Government Decree No. 430, ventilators, oxygenators, heart-lung systems, as well as various test systems for SARS-Cov-2, including diagnostic systems for antibodies to a new type of coronavirus, fell under the simplified registration procedure.
For disposable medical devices – gloves, medical masks, gowns, respirators, shoe covers – it was allowed to put them into circulation and use without registration in Russia if there is a registration certificate in the country of origin.
In June 2020 the Government of the Russian Federation expanded the application of the Government Decree No. 430 to another 363 types of medical devices – it includes equipment, as well as consumables for laboratory diagnostics, medical furniture, refrigeration units, breathing circuits, connectors and valves for mechanical ventilation, patient monitors, pulse oximeters, bronchoscopes, aspiration systems, bactericidal lamps and other medical devices.
In November 2020 the simplified registration scheme for medical devices was extended until the end of 2021.
As of December 2020, according to the Federal Service for Surveillance in Healthcare, more than 300 million medical devices were imported into Russia in accordance with the Government Decree No. 430, namely personal protective equipment, gowns, goggles, as well as medical devices for in vitro diagnostics and others.