Dual-Track Registration in Belarus: National Procedure versus EAEU Route

1. Key takeaways

Belarus is a member of the Eurasian Economic Union, and medical devices currently face two parallel channels: national state registration (the № 211 procedure) and union-wide registration (the rules of the 2014 Agreement). Which one to choose depends on two variables — how many member states the target market covers, and when marketability must be obtained.

2. Legal basis

3. Expert insights

Insight 1: the dual track is not a permanent either-or product strategy but a transitional arrangement with a time window. Under the union agreement as originally adopted, from 1 January 2026 medical devices within the union could only be registered under union rules. That date was postponed by the protocol signed on 29 December 2025. The coexistence of the two tracks is therefore essentially a transitional arrangement, not a long-term institutional design. A company that plans on the assumption that the choice will remain open indefinitely will be caught unprepared when the window closes.

Insight 2: for a single-market objective, the national route still carries time value. If sales target only 1 market — Belarus — the national state registration, after the № 211 switchover, carries a defined technical review time limit (a baseline of 90 calendar days). The union route involves two stages, the reference state and the recognizing states (recognition proceeds country by country). Whether to cover multiple countries is therefore the first watershed in route selection.

Insight 3: for multi-market objectives, the union route has a lower marginal cost. If the product is to cover Belarus, Russia, Kazakhstan and other member states at the same time, the union route allows one review followed by recognition in several countries, avoiding a separate technical review in each state. The union route, however, imposes heavier requirements on dossier completeness, language versions and inspection of manufacturing sites.

Insight 4: the exemption list is a third channel, but its scope is narrow. The protocol of 9 February 2026 expanded the union-level scenarios exempt from registration, including: devices custom-made to an individual patient’s order and intended solely for that person’s use; devices imported to save the life of a particular patient according to vital indications with the approval of the competent authority; devices produced within a member state solely for export; and 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. All four are special scenarios; ordinary commercial sales do not qualify.

4. Practical recommendations

1. Answer the market list before discussing the route. List the target member states: if it is only Belarus — 1 market — evaluate the national route first; with 2 or more markets, evaluate the union route first.
2. Schedule backward from the marketability date. If marketability must be obtained by a fixed date, model the national route on the 90-day baseline of № 211 and compare it with the two-stage calculation of the union route before deciding.
3. Do not assume a Russian certificate covers Belarus. GRZAN repeatedly encounters this misconception in cross-border projects: a registration certificate obtained in Russia does not automatically extend to the Belarusian market; the product must go through the Belarusian national procedure or list Belarus as a recognizing state in the union route.
4. Treat the exemption list as an exception. Use it only when one of the four scenarios genuinely applies, and retain the written approval of the competent authority.

5. Verification checklist

• □ List of target member states compiled and route selected on that basis
• □ National-route marketability modeled on the 90-day baseline
• □ Two-stage calculation of the union route (reference state and recognizing states) completed
• □ No mistaken assumption that a Russian certificate automatically covers Belarus
• □ If the exemption list is invoked, written approval of the competent authority obtained

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.

Business inquiries: info@grzanglobal.com