The website of the Federal Service for Surveillance in Healthcare has published the list of medical devices that can be registered according to the facilitated procedure in case of deficiency or its hazard. Currently, the list includes more than 30 lots, including consumables, chemical reagents and equipment for laboratory diagnosis.
In the end of May, the Government assigned the special multiagency commission represented by the Federal Service for Surveillance in Healthcare, The Ministry of Healthcare, the Ministry of Finance, The Ministry of Industry and Trade, The Ministry of Economic Development and other authorities according to Resolution No.552 dated the 1st of April, 2022. This commission has accepted the first list of the deficient medical devices that should be changed in the future according to the market situation.
The devices included into the list can get the state registration certificate according to the simplified procedure. The reduced terms are 22 working days for some positions and 5 working days for the other. Moreover, the facilitated procedure allows to add changes to the registration portfolio of the device as soon as possible.
The Resolution is valid till the 1st of September, 2023.