552 - Decree of the Government of the Russian Federation 552 (accelerated registration of medical devices)
Order of Russian Government 552 is one of the measures accelerating the registration of medical devices in Russia. This document was adopted in April 2022 to prevent a shortage of medical devices in Russia.
The Order includes two main subparagraphs:
- Simplification of the existing primary registration scheme (Order of Russian Government 1416) for all types of medical devices.
- Introduction of an even more quick registration scheme for medical devices and in vitro diagnostic devices from the list in the appendix.
stage 1
Legal manufacturer prepares legalized company documents and technical dossier
stage 2
Application, TF and IFU preparation by AR
stage 3
AR applies for samples import permission to RZN and support custom clearence
stage 4
Preclinical trials: biocompatibility trials, technocal trials, EMC etcetera
stage 5
TF and IFU legalization by legal manufacturer
stage 6
Clinical trials
stage 9
RZN issues registration certificate (with expiry date)
stage 8
RZN expert center review
stage 7
Submissions to RZN (expert center)
