Kazakhstan Medical Device Classification: Dual-Source Rules and the 2025 Amendment

1. Key takeaways

Kazakhstan’s medical device classification rules have two sources. The national route applies Order No. ҚР ДСМ-281/2020 of the Ministry of Health (2020, effective 10 calendar days after first official publication); the union route applies Decision No. 173 of the Board of the Eurasian Economic Commission (December 22, 2015, as amended by Decision No. 65 of May 23, 2023 and Decision No. 18 of February 18, 2025). Both rule sets use the same four-class structure (1 / 2а / 2б / 3), but the detailed rules differ, and the 2025 amendment in Decision No. 18 specifically adjusted the treatment of software and in vitro diagnostic devices. A classification conclusion must state the version of the rules on which it relies; without that statement it cannot pass review. Because classification determines testing scope, inspection triggers and post-market obligations, an error here propagates through the entire compliance chain rather than staying contained in one document. In practice, the classification memo is one of the first documents reviewers open, because every downstream document cites its conclusion.

2. Legal basis

3. Expert insights

Insight one: fix the pathway first and then the classification; the order cannot be reversed. The choice of classification rules follows from the registration route, not the other way around. Companies sometimes classify under the rules they know best and only then select the route, which produces a mismatch between the classification basis and the filing procedure that must be redone before submission. The correction is cheap at the planning stage and expensive after the dossier has been assembled, so the route decision should be captured in writing before any classification work begins. Recording the route decision and the named classification rules in the same memo keeps both decisions auditable together.

Insight two: Decision No. 18 of February 18, 2025 is the most recent substantive adjustment. The union-side rules were amended once in 2023 and once in 2025, and the 2025 amendment targets software and in vitro diagnostic devices. Every classification conclusion formed before 2025, especially for companion diagnostics, stand-alone software and self-test IVDs, should be re-checked under the new treatment before it is cited in a fresh submission, because reviewers will apply the current text and not the version the company used. The re-check should also cover accessories and combination products, whose classification can change under the amended software rules.

Insight three: a class conclusion must state basis, clause and version. Writing only that the product is class 2а is not sufficient. The classification rationale should state whether Order No. ҚР ДСМ-281/2020 or Decision No. 173 is relied on, which specific rule applies, and the date of the version used. Reviewers check exactly these three items, and a missing version date is one of the most easily avoided remedy triggers in an otherwise complete dossier. Where both routes are planned for the same product, prepare two classification memos rather than one compromise text that serves neither well.

Insight four: the overlap between the two rule sets is the foundation for reusing national and union dossiers. The two systems reach highly consistent outcomes for conventional active and non-active devices; the differences concentrate on software, IVDs and drug-device combinations at the frontier categories. GRZAN therefore plans evidence packages on a strategy of reuse for conventional categories and dual assessment under both rule sets for frontier categories, which keeps the dossier work honest without doubling the effort where it is not needed.

Insight five: a classification conclusion shapes the whole compliance chain, not only the depth of review. The class determines the scope of technical testing and toxicological studies, whether a manufacturing site inspection is triggered and how wide its coverage is, and the intensity of post-market surveillance. The cost of a classification error is global rather than local: it resurfaces in every downstream document built on top of it.

4. Practical recommendations

1. State three elements in the classification rationale: the name of the rules relied on, the applicable clause, and the version date.
2. After Decision No. 18 of February 18, 2025, re-check existing conclusions for software and IVD categories once.
3. Handle conventional categories with national and union reuse, and frontier categories with dual assessment under both rule sets.
4. Cite the classification conclusion consistently in the test plan, the inspection preparation and the surveillance plan.
5. Fix the classification basis at the evidence-package planning stage to avoid redoing work after a mid-course route change.

5. Verification checklist

• □ The registration route has been determined and the classification rules selected accordingly
• □ The classification rationale contains three elements: rules name, applicable clause, version date
• □ Software and IVD conclusions have been re-checked under Decision No. 18 of 2025
• □ The classification conclusion is cited consistently in the test plan, inspection preparation and surveillance plan
• □ The reuse or dual-assessment strategy for conventional and frontier categories is defined
• □ The dossier adjustment path in case of a classification change is predefined

GRZAN provides registration support in Kazakhstan for medical device manufacturers, importers and authorized representatives, covering dual-source classification, 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.