Medical devices registration under the EAEU rules

09 August 2021
Elizaveta Gromova
Anna Kuminova
Associate

From 1 January 2022, the registration of medical devices will proceed only under the Eurasian Economic Union rules.

In-transition

The EAEU Council Decision No. 46 «On the Rules for Registration and Examination of the Safety, Quality and Effectiveness of Medical Devices» was adopted on 12 February 2016. According to the Rules, the registration of medical devices shall be performed in accordance with the EAEU rules from 1 January 2022, while the national system of medical devices registration will no longer be in force. At the same time, until 31 December 2021, medical devices registration is possible under one of the following systems: national or Eurasian.

Therefore, EAEU Member States agreed on mechanisms of the state control for quality and safety of medical devices and developed a convenient procedure for the transition period.

On 5 April 2021, the Council of the Eurasian Economic Commission approved amendments to the Agreement on Uniform Principles and Rules for Circulation of Medical Devices (Medical Devices and Medical Equipment) from 23 December 2014.

Under the amendments, medical devices registered under national rules may be circulated in the territory of that state until national the registration certificate expires.

Medical devices registered under national rules may be re-registered, as well as the registration dossiers may be changed till 31 December 2026.

In our opinion, medical devices registration procedure in accordance with the EAEU rules is more complicated than a national one, however these amendments should unify the current rules in all EAEU countries, which will increase the safety, effectiveness, and efficacy of medical devices.