According to the Federal Service for Surveillance in Healthcare, last year 423 items of medical devices successfully passed accelerated registration. Of these, 31 products fell under the program of simplified registration of deficient medical devices in accordance with Resolution No. 552 dated the 1st of April, 2022. Another 158 items were registered in accordance with Resolution No. 430 dated the 3rd of April, 2020, which provides for registration rules under emergency situations. The majority of medical devices, 234 items, were registered under Resolution No. 299 dated the 18th of March, 2020, which defines the registration rules for certain types of medical devices.
In early April, a program was launched to simplify the registration of medical devices with a high risk of deficiency. First of all, the program has reduced the registration procedure from 50 to 22 days. In addition, it has become easier to make changes to the registration dossier. The list of documents required for submission has also been reduced.
The first product was registered under the accelerated procedure in July. It is a set of reagents for laboratory detection of the monkeypox virus.
It is important to note that the simplification of the registration procedure for certain groups of goods began in 2020 due to the pandemic. The Federal Service for Surveillance in Healthcare reports that over this period, more than two thousand medical devices were registered under simplified rules, including mainly masks, gloves and products for medical personnel. About 700 series of medical devices for use in emergencies and for work with diseases dangerous to others received a registration certificate much earlier due to the simplification of registration rules.
