Registration of medical devices under national regulations will be completed by 2028.

On December 29, the states of the Eurasian Economic Union signed a Protocol on amendments to the Agreement on Common Principles and Rules for the Circulation of Medical Devices (Devices of medical intended use and Medical Equipment) within the EAEU in terms of extending the transition period for completing national registration until 2028.

The document provides for the possibility of submitting applications for expertise and registration of medical devices by December 31, 2027 in accordance with the procedure provided for by the law of the Union or the legislation of a Member state. Previously, this possibility was provided until December 31, 2025, and it was assumed that from January 1, 2026, registration of medical devices will be carried out only in accordance with the law of the Union.

The extension of the transition period established by the Protocol will allow the EAEU states to optimize the registration system for switching to a single registration of medical devices under the Union's rules.

The Protocol begins to be temporarily applied after 10 days from the date of its signing and enters into force from the date of receipt by the Commission of the last written notification on the implementation by the EAEU member States of the internal procedures necessary for its entry into force.