EAEU Extends Medical Device Registration Under National Rules to End-2027

On 29 December 2025 in Moscow, the member states of the Eurasian Economic Union (EAEU) signed a protocol amending the Agreement of 23 December 2014 on common principles and rules for the circulation of medical devices within the EAEU. The protocol extends the transitional period during which applications for the expertise and registration of medical devices may be filed under either Union law or the national legislation of a member state until 31 December 2027. The previous deadline was 31 December 2025.

Under the protocol, the deadline for re-registration of devices registered under national rules and for applications to amend registration documents has been extended to 31 December 2028. The Eurasian Economic Commission announced the change under the headline "Registration of medical devices under national rules will be completed by 2028". The protocol has been provisionally applied since 10 days after signing and will enter into force once the Commission receives the last notification that member states have completed their domestic procedures.

This is the second extension of the transitional period: an earlier protocol signed on 13 February 2023 had moved the deadline from 31 December 2022 to 31 December 2025. The Russian Federation ratified the new protocol by Federal Law No. 288-FZ of 4 August 2026. The aim of the extension is to give member states time to optimise their registration systems for the switch to unified registration under Union rules.

For companies supplying medical devices and consumables to Kazakhstan and other EAEU markets, this means the national registration route stays open for a while longer, but preparing for single EAEU registration remains essential in the long run. At CSC we work with our partners to keep product dossiers on schedule.

Source: Eurasian Economic Commission (eec.eaeunion.org), news of 30.12.2025 and 14.02.2023; Alta-Soft (alta.ru), 06.08.2026; ConsultantPlus (consultant.ru), 30.12.2025.