Medical devices registration by EAEU rules

Since 2017Registration of medical devices according to the rules of the Eurasian Economic Union (EAEU) has become available .

The procedure for registering medical devices according to the EAEU rules is governed by the decision of the Council of the 
Eurasian Economic Commission of February 12, 2016 No. 46 "On the regulations for registration and examination of the safety, 
quality and effectiveness of medical products".

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 – 10 months;
 
2a and  2b class – 12 months;
 
3 class  – 12-15 months.

Note; From January 1, 2022, all medical devices in Russian market will be registered only under the rules of the Eurasian Economic Union.