06.08.2026 Regulation #EAEU #Russia #Import #Trade agreements

Russia extends transition period for EAEU medical device registration

Russia's president has signed Federal Law No. 288-FZ of August 4, 2026, ratifying a protocol amending the Agreement on Common Principles and Rules for the Circulation of Medical Devices within the Eurasian Economic Union of December 23, 2014. The protocol was signed by the EAEU heads of state on December 29, 2025, in Moscow and had been provisionally applied since January 9, 2026 (Alta-Soft; Alta-Soft). The ratification formalizes an extension of the transition period during which manufacturers can register medical devices under the national rules of individual member states rather than solely under unified EAEU procedures.

How the registration timeline changes

Before the protocol was signed, medical device registration across the EAEU was expected to shift entirely to Union-wide rules starting January 1, 2026 — a deadline set by an earlier protocol of February 13, 2023, which had extended the prior transition period to December 31, 2025 (EEC). The new protocol pushes that cutoff further back:

applications for examination and registration of a medical device under a member state's national rules can now be filed until December 31, 2027 (Alta-Soft; ConsultantPlus);
re-registration of devices previously registered under national rules is permitted until December 31, 2028 (ConsultantPlus);
changes to the registration files of such devices are likewise allowed until December 31, 2028 (ConsultantPlus).

Who is affected and what it means for the market

The change concerns manufacturers and importers of medical devices and medical equipment across all EAEU member states — Russia, Belarus, Kazakhstan, Armenia and Kyrgyzstan. Keeping the national registration track in place reflects the fact that the Union's common medical device market is not yet fully operational, and the extension is meant to keep member states' healthcare systems supplied with the equipment they need without disruption (Alta-Soft). In practice, companies already registering — or planning to register — devices under national rules will not need to rush a switch to the unified EAEU procedure; they gain extra time to transition, and previously registered devices get a longer window for re-registration and dossier updates.

Timeline and transition period

Law No. 288-FZ ratifies a protocol that had been provisionally applied since January 9, 2026, pending completion of domestic ratification procedures in all Union member states (Alta-Soft). The key deadlines businesses need to track are December 31, 2027 (the last date to file applications under national rules) and December 31, 2028 (the deadline for re-registration and for amending registration documents for medical devices).

Primary sources

This material is for information only and does not constitute legal advice or customs consulting. Verify changes against the primary sources before acting.