National registration of medical devices may be prolonged

We have already informed that under the EAEU Council Decision No. 46 “On the Rules for Registration and Examination of the Safety, Quality, and Effectiveness of Medical Devices” from 1 January 2022 registration of medical devices shall be performed under the EAEU Rules. (link)

However, on 24 December 2021 Council of the Eurasian Economic Commission considered amendments to the Agreement on Uniform Principles and Rules for Circulation of Medical Devices (Medical Devices and Medical Equipment) from 23 December 2014 regarding prolongation of national registration till 31 December 2022. (link)

The Protocol amending the Agreement on Uniform Principles and Rules for Circulation of Medical Devices (Medical Devices and Medical Equipment) was signed on 30 December 2021 by State-members and submitted for domestic procedures. (link)

Under the Protocol, medical devices registered in accordance with the national rules may be circulated in the territory of that state until the national registration certificate expires. Till 31 December 2026 such national registrations may be re-registered, as well as the registration dossiers may be changed. The Protocol provisionally applies by the Member-States from 1 January 2022.

Moreover, according to the Roszdravnadzor official website, Roszdravnadzor does not accept applications for medical devices registration under national rules starting from 1 January 2022. However, it is mentioned that information on the possibility of national registration of medical devices will be provided later. (link)