Special modes of registration proceduress

In connection with the pandemic of the coronovirus Covid 19, the Government of the Russian Federation introduced a simplified (accelerated) registration procedure for a number of products. The requirements for the registration dossier and a description of the procedure for such registration are enshrined in Decree No. 430 of April 3, 2020, “On the Specifics of Circulation of Medical Devices, including State Registration of a Series (Lot) of Medical Device”.

The list of medical devices with respect to which a simplified registration procedure can be applied is determined by the Appendix to this Regulation.

These are personal protective equipment (dressing gowns, masks, gloves, shoe covers), mechanical ventilators, kits and separate materials for in-vitro diagnosis of the COVID- 19 virus.

In accordance with this decision, the entire registration process should take no more than a week. Given the time required for testing, a medical device can be brought to market in 3-4 weeks.