Kazakhstan Regulatory Windows 2027-2028: Deadlines and Transition Planning for Medical Devices

1. Key takeaways

December 31, 2027 and December 31, 2028 are two deadlines of a fundamentally different nature, and mixing them up leads directly to scheduling errors. December 31, 2027 governs new applications: after that date, expert review or registration applications can no longer be submitted under the national rules of a member state. December 31, 2028 governs the existing stock: until then, expert review, registration and registration dossier change applications can still be filed under national rules, for the purpose of maintaining products already registered under those rules. Medical devices registered under national rules before December 31, 2027 may continue to circulate within their member state after that date, as long as the registration documents remain valid. Read together, the two dates define the correct posture for planning: new market entries must be locked before the end of 2027, while maintenance work on existing certificates enjoys one additional year of runway under the familiar national procedures before the union rules take over entirely. Companies that internalize this split early avoid the most expensive failure mode of the transition period: discovering in 2028 that a change they considered routine must now be run through the union procedures for the first time, before unfamiliar authorities and under unfamiliar documentation standards.

2. Legal basis

3. Expert insights

Insight one: the two dates correspond to two categories of actions, and internal schedules must be built separately. New-application schedules close at December 31, 2027; maintenance of the existing stock (changes of manufacturing site, model extensions, replacement of the authorized representative, label revisions) closes at December 31, 2028. Writing both onto a single sheet is the most common source of scheduling errors in real projects. GRZAN recommends two physically separate schedule tables with distinct owners, so that a new filing is never delayed by maintenance work and a maintenance action is never mistaken for a new application that has already been secured. When the two tables are kept apart, each can carry its own milestones, owners and contingency buffers, and quarterly reviews can compare progress against the correct deadline instead of an average of two different ones.

Insight two: what is extended is the choice of procedure, not the validity of certificates. The protocol extends the window during which companies may choose which procedure to apply; it does not touch the validity period of registration certificates. Kazakhstan’s national registration certificates for medical devices carry no expiry date in the first place (Order No. 146 of November 18, 2025), so there is no problem of a certificate expiring, only the question of whether the national procedures can still be used for a given action. Internal communications that describe the window as a certificate validity issue should be corrected immediately, because that framing distorts both urgency and budget decisions.

Insight three: after the window closes, existing certificates follow a pattern of continued circulation plus maintenance under union rules. Products registered under national rules before the window closes keep their registration documents valid for their term and continue to circulate within the member state. However, major changes after 2028 must be handled under union rules, and this constitutes the long-term compliance cost of the existing portfolio. Companies should map now which of their registered products are likely to need major changes in the following years, so that the transfer to union-rule maintenance does not arrive as a surprise. Mapping the likely major changes in advance also reveals which products are better served by a fresh union registration than by repeated maintenance of an aging national dossier.

Insight four: the entry-into-force status of the protocol requires continuous tracking. The protocol of December 29, 2025 applies provisionally 10 days after its signing; formal entry into force awaits completion of domestic procedures by all member states. Belarus completed parliamentary ratification on June 3, 2026, and the progress of the remaining member states must be tracked continuously. Any schedule that relies on this protocol for long-term planning should include periodic review points, so that the plan is corrected as soon as any member state changes pace. A short quarterly review note covering each member state is usually enough to keep the plan current without turning monitoring into a project of its own.

4. Practical recommendations

1. Build two schedule tables: the new-application table closes at December 31, 2027, and the maintenance table closes at December 31, 2028.
2. Complete a portfolio inventory within 2026 to identify which products are worth registering nationally inside the window.
3. Where possible, schedule major changes to existing products before December 31, 2028, since handling them under national rules is simpler.
4. Review the ratification and application status of the protocol in each member state once per quarter.
5. Prepare product lines planned for after the window closure at union-rule depth now, to avoid redoing foundational work later.

5. Verification checklist

• □ New-application and maintenance schedule tables have been established separately
• □ The new-application filing date falls before December 31, 2027
• □ Changes and dossier consolidation for existing products are filed before December 31, 2028
• □ The portfolio inventory is complete and the products worth registering inside the window are identified
• □ A periodic review point is set for the ratification status of the protocol in each member state
• □ Internal communications do not misstate the procedural window as a certificate validity period

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

Regulatory information verified as of October 29, 2026.