Kazakhstan Medical Device Registration Certificate with No Expiry Date under Order No. 146

1. Key takeaways

Under the national rules of Kazakhstan, the registration certificate for a medical device has no expiry date (бессрочно). This rule was made explicit when Order No. 146 of the Minister of Health dated November 18, 2025 (published November 20, 2025, effective 10 calendar days after publication) amended Order No. ҚР ДСМ-16. A strict distinction must be drawn: the five-year validity period applies only to the first registration of imported medicines; the certificates for domestically manufactured medicines and for all medical devices carry no expiry limit, and the same open-ended status applies after re-registration. A certificate without an expiry date means there is no periodic certificate renewal exercise, but it also means the regulatory focus shifts to dossier variations and safety supervision. The accuracy of the register record is sustained not by a renewal deadline but by the certificate holder’s own duty to declare changes, which inverts the compliance dynamics familiar from markets built around fixed validity periods and forces a different kind of internal discipline. Teams accustomed to renewal-driven compliance should rebuild their regulatory calendars around change triggers instead of expiry dates, otherwise the first supervisory inspection after launch will be the first time the gap becomes visible.

2. Legal basis

3. Expert insights

Insight one: the real function of Order No. 146 is alignment with the Union rules. Order No. 146 amends an order that governs medicines and medical devices together, and its arrangements on certificate validity move the national system closer to the Eurasian Economic Union framework. Medical devices receive an open-ended certificate, while the medicines side retains the five-year validity and re-registration mechanism, with transition exemptions and an automatic extension mechanism for the validity of certificates covering medicines of strategic importance. Once this structure is understood, it becomes clear why the Kazakh device regime appears looser than the medicines regime: it is not an oversight but a deliberate design outcome of harmonizing with Union rules on two parallel tracks.

Insight two: no expiry moves the compliance focus from renewal to variation. In most markets, companies rely on the renewal cycle to passively refresh their dossier; Kazakhstan has no such mechanism, so the accuracy of the dossier depends entirely on proactive variation filings. Every change to the manufacturing site, the authorized representative, the model specifications or the label text must go through the variation procedure item by item. The consequence of neglecting variations is not an expired certificate but a register record that no longer matches the physical product, and during supervisory inspections that mismatch constitutes a violation in its own right. GRZAN communicates this to clients in a standard formulation: the qualification lasts indefinitely, and so do the obligations.

Insight three: no expiry does not mean untouchable. A registration certificate can be suspended or revoked on safety grounds, and the monitoring regime under Order No. ҚР ДСМ-320/2020 as well as the manufacturing inspections under Decision No. 106 can each become trigger sources. The standing risks are therefore vigilance findings and inspection outcomes, not calendar dates. A certificate holder that maintains its variation filings and its post-market monitoring duties faces no renewal cliff; one that treats the open-ended certificate as a reason to freeze compliance activity converts a stable asset into a contingent liability.

Insight four: combined with the December 31, 2027 window, the system creates genuine strategic value. Completing one national registration before the window closes locks in long-term market access for the cost of a single project. This is precisely the feature that distinguishes Kazakhstan from neighbouring markets, where certificates expire on fixed cycles and renewals consume budget and attention indefinitely, and it explains the current surge of interest in the national pathway. For portfolio planning, the combination also changes the arithmetic of product-line decisions: a device that would barely justify a five-year renewable certificate elsewhere can support a one-time registration investment here, provided the variation discipline described above is maintained throughout the product’s life.

4. Practical recommendations

1. Build a variation trigger list covering manufacturing site, authorized representative, model specifications, label text and packaging specifications, and feed every such change into a proactive filing workflow with a named owner and a target filing date.
2. Verify the consistency of the four elements between the register record and the physical product once a year (manufacturer, manufacturing site, model configuration, intended use).
3. Do not delay a filing to save one variation fee; the cost of an inaccurate register record exceeds the variation fee many times over.
4. Plan national registration projects backwards from December 31, 2027 as a hard deadline.
5. When citing the five-year validity rule internally, restrict it to imported medicines and never extend it to medical devices.

5. Verification checklist

• □ It is confirmed that the certificate for this project has no expiry date (device treatment)
• □ A variation trigger list exists and is assigned to accountable roles
• □ The four-element consistency between register record and physical product is verified annually
• □ Safety-related suspension and revocation triggers are included in risk monitoring
• □ The national registration project is planned backwards from December 31, 2027
• □ Internal documents do not apply the five-year medicine validity period to medical devices

GRZAN provides registration support in Kazakhstan for manufacturers, importers and authorized representatives, covering certificate strategy, variation management and register maintenance. For assistance, contact info@grzanglobal.com.

Regulatory information verified as of October 29, 2026.