Medical devices registration by Russian Federation rules
The procedure for state registration was approved by the Decree of the Government of the Russian Federation No. 1416 dated
December 27, 2012 "On Approval of the Rules for State registration of medical devices". state registration of medical devices
in Russian Federation ended on December 31, 2021.we recommend you to register your medical devices according to the EAEU rules
Terms of registration of medical devices.
The timing of obtaining a registration certificate for a medical device depends on which medical device you plan to register, what risk class is assigned to it and what tests need to be carried out.
The timing of obtaining a registration certificate for a medical device depends on which medical device you plan to register,
what risk class is assigned to it and what tests need to be carried out.
1st class – 8 months;
2a and 2b class – 10 months;
3 class – 12 months.