EAEU Transition Protocol Timeline: What It Means for Medical Devices in Kazakhstan

1. Key takeaways

The switch of medical devices in the Eurasian Economic Union from national rules to union rules has been postponed several times, and the current dates are fixed by the amending protocol signed on December 29, 2025: the window for submitting expert review or registration applications under the national rules of a member state closes on December 31, 2027; the window for submitting change and dossier consolidation applications under national rules is retained until December 31, 2028. The protocol applies provisionally 10 days after its signing; formal entry into force awaits completion of domestic procedures by all member states, and Belarus completed parliamentary ratification on June 3, 2026. What is postponed is the timing of the procedural switch, not regulatory intensity: on the union side, the classification rules were updated in parallel (the 2025 amendment by Decision No. 18) and the list of products exempt from registration was expanded (the protocol of February 9, 2026). Companies should therefore read the delay as preparation time granted by the regulator, not as permission to slow down, because the substantive rule environment continues to advance while the transition clock runs. Read as a whole, the amendment record shows a regulator that is shortening the transition while lengthening the runway for preparation.

2. Legal basis

3. Expert insights

Insight one: the mechanism of every postponement is an amendment to Article 11 of the Agreement. Each delay has been implemented by signing a protocol that rewrites the text of Article 11 of the 2014 Agreement. Understanding this matters: what is being delayed is the transition clause, not the registration rules themselves. The substantive union rules (Decision No. 46, No. 106, No. 27 and others) have kept operating and updating throughout every postponement, so companies that suspend their union-readiness work during a delay are pausing against a moving baseline rather than a frozen one. Tracking amendments to Article 11 is therefore a cheap way to anticipate every future shift in the timetable.

Insight two: provisional application and formal entry into force are two different states. The protocol of December 29, 2025 applies provisionally 10 days after its signing, while formal entry into force requires delivery of the final written notification completing domestic procedures in all member states. For scheduling purposes, provisional application is already sufficient to support business judgment; but in contexts that require legal certainty, such as investment decision documents, the status of the protocol should be stated expressly rather than assumed.

Insight three: the extension of the transition period and the upgrading of the rules happen at the same time; do not read only the former. Decision No. 18 of February 18, 2025 updated the classification rules; the protocol of February 9, 2026 expanded the exemption list; and on April 7, 2026 the Board of the Eurasian Economic Commission adopted methodological recommendations on manufacturing inspections of medical devices, an advisory document. What companies face at the end of the transition is an upgraded set of union rules, not a simple continuation of the current text, and evidence packages prepared today should already anticipate those upgraded requirements. Advisory documents deserve attention even though they bind no one, because they preview how the authorities intend to conduct inspections after the transition ends.

Insight four: the alignment steps on the Kazakhstan side were completed in step with the union process. Order No. 146 of the Ministry of Health of November 18, 2025 amended Order No. ҚР ДСМ-16, arranging the validity of registration certificates and the treatment of strategically important medicines, and confirming that medical device registration certificates carry no expiry date. This is a concrete instance of domestic member-state rules converging on the union framework while the transition clock is still running.

Insight five: the real value of the postponement is preparation time, not deferred compliance. The two-year window should be used for: completing national registrations to lock in long-term access, preparing evidence packages to union-rule depth, and sorting out the route allocation across the product portfolio. Using the window to wait and see is the least profitable possible use, because it converts preparation time into compression pressure at the end of the window when everyone else is filing too.

4. Practical recommendations

1. Adopt the current dates in all schedules: new applications December 31, 2027; changes December 31, 2028.
2. When citing the protocol in legal documents, note its status as provisionally applied and pending formal entry into force.
3. Use the window to prepare evidence packages to union rules, not to postpone compliance actions.
4. Track the domestic ratification progress of each member state once per quarter.
5. Track in parallel the updates to the substantive union rules (classification, the exemption list, the inspection method recommendations).

5. Verification checklist

• □ Schedules use the current dates: new applications 2027-12-31, changes 2028-12-31
• □ Legal documents note the provisional application status of the protocol
• □ Preparation of union-rule evidence packages has started and has not been postponed on grounds of the delay
• □ Periodic tracking points are set for domestic ratification progress in each member state
• □ The impact of union-side substantive updates (Decision No. 18, the 2026-02-09 protocol, the 2026-04-07 recommendations) has been assessed
• □ The alignment requirements of Order No. 146 on the Kazakhstan side have been implemented

GRZAN provides registration support in Kazakhstan for medical device manufacturers, importers and authorized representatives, covering transition planning, union and national filings, dossier preparation and post-grant registration maintenance. For assistance with this topic, contact info@grzanglobal.com.

Regulatory information verified as of October 29, 2026.