The 2014 EAEU Medical Device Agreement and Its 2025-2026 Protocols

1. Key takeaways

The Eurasian Economic Union Agreement of 23 December 2014 is being amended by two protocols: one signed on 29 December 2025 extends the transition period, and one signed on 9 February 2026 expands the list of exemptions from registration. Together, the two documents determine how much room Belarus-bound companies will have for route selection over the next two years.

2. Legal basis

3. Expert insights

Insight 1: the two protocols have different entry-into-force mechanisms and cannot be read against a single date. The protocol extending the transition period uses a two-stage mechanism — provisional application 10 days after signature, with formal entry into force once each member state completes its internal procedures — whereas the protocol expanding the exemption list is expressly provisionally applied from 2026-02-19. When citing them, companies should state each instrument’s own dates and should not merge them into an entry into force from 2026.

Insight 2: all four exemption scenarios carry strict situational limits. First, devices custom-made to an individual patient’s order and intended solely for personal use; second, devices imported to save the life of a particular patient according to vital indications with the approval of the competent authority; third, devices produced within a member state solely for export; fourth, procedure sets and first-aid kits assembled within a member state from registered devices and medicines under that state’s rules and circulating only within that state. The first two require the qualifier of a particular patient or personal use; the latter two are bounded by export or circulation within the producing state — products imported and sold commercially on the domestic market do not fall within any of them.

Insight 3: Belarus’s approval chain is clear, but its last verifiable step has not been completed. The verifiable milestones are: the President’s Decree № 441 of 17 December 2025 approving the draft protocol as the basis for negotiation, and the approval by the House of Representatives on 3 June 2026. For the consideration by the Council of the Republic and the President’s signature, GRZAN has not verified official texts, and this series does not use them as established conclusions — those items remain pending verification.

Insight 4: the two dates for the extension of the transition period differ between sources. As stated by the Belarusian Minister of Health in the House of Representatives, the transition period is extended to 31 December 2027, with the possibility retained to accept review and registration applications under member-state legislation until 31 December 2028, while the circulation within the union of devices registered under member-state legislation continues until 31 December 2027. A separate wire-service formulation puts the deadline for filing applications under national rules at 31 December 2027. Because the two formulations disagree on what the 2027 and 2028 dates each refer to, this series records them as coexisting accounts.

4. Practical recommendations

1. Schedule on the most conservative reading. Use 2027-12-31 as the baseline deadline for filing applications under the national procedure, and build no dependency on a possible extension to 2028.
2. Cite the two protocols with their own dates. Do not write an entry into force from 2026; write separately: signed 2025-12-29, provisionally applied 10 days after signature, and signed 2026-02-09, provisionally applied 2026-02-19.
3. Manage the exemption list as an exception. Before use, verify the limiting conditions of each of the four scenarios item by item and retain the approval documents of the competent authority.
4. Track the approval progress. The latest verifiable node of Belarus’s approval chain is the House of Representatives approval of 2026-06-03; subsequent nodes follow official publications.

5. Verification checklist

• □ Signing dates and provisional application points of the two protocols distinguished
• □ 2027-12-31 adopted as the scheduling baseline for the national procedure
• □ Limiting conditions of the four exemption scenarios verified
• □ Belarusian approval milestones recorded (Presidential Decree № 441, 2025-12-17; House of Representatives, 2026-06-03)
• □ The 2027 and 2028 dates not merged into a single statement

Regulatory information verified as of 2026-10-30.

In the Eurasian Economic Union market, GRZAN concentrates its core capabilities in three areas. First, distinguishing between the union-wide registration route and each member state’s national registration route — their applicable conditions and remaining time windows. The national registration procedure of Belarus has been fully replaced by Council of Ministers Resolution No. 211 of 28 April 2026 (state registration number 6-1/55925, effective 1 May 2026), which caps the total duration of preliminary technical work at 90 calendar days, keeps the list of that work closed and prohibits the organizing body from expanding it, while the window for filing applications under the national procedure has 31 December 2027 as its key date, so the choice of route must be made in step with the time window. Second, local authorized representative services: GRZAN may act as the manufacturer’s statutory representative in Belarus, undertaking registration submissions, responses to technical queries, changes to the registration dossier and post-market reporting obligations, and it has updated its liaison arrangements after Council of Ministers Resolution No. 378 of 27 July 2026 (effective 30 July 2026) transferred the adverse-event functions to the State Institution State Medical Products Supervision (Gosfarmnadzor). Third, quality system and testing support: GRZAN assists in establishing a quality management system that meets ISO 13485 requirements and in organizing technical documentation for the chosen route — the national route follows the annexes to Ministry of Health Resolution No. 55, and the union route follows Decision No. 46 of the Board of the Eurasian Economic Commission.

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