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Registration certificates validity for medical devices after December 31, 2021

Nowadays, the topic concerning the validity periods for Registration certificates of medical devices is under discussion. The cause is the transition period for medical device registration from national registration rules to uniform rules of the Eurasian Economic Union (later on EAEU rules).

The Registration certificates validity period and transition period are established by the instruction No. 142 of Eurasian Economic Commission of September 2, 2019.

The main conclusions we’ve gathered from the above document are presented below:

  • applying for registration of medical devices according to national registration rules is permitted until December 31, 2021;

  • applications submitted up to December 31, 2021 will be processed in accordance with national registration rules;

  • to make amendments in registration documentation of medical devices registered will be possible accordance with national registration rules;

  • the issued registration certificates for medical devices will be valid up to their expiration date. This fact is valid both for termless and terminable registration certificates. The last ones can be replaced with termless registration certificates until December 31, 2026, what urgent for the Republic of Belarus and the Kyrgyz Republic, in accordance with national registration rules.

So, at the moment, the registration under the national rules has many advantages in comparison to the registration under the EAEU rules. The main advantage is that we have accumulated quite a lot of experience in the way of national registration rules what let us plan the timing and budget quite accurately for obtaining registration certificates. Also, it should be noted that only 4 medical devices were registered according to the rules of the EAEU by the beginning of 2021.


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