Kazakhstan IVD Registration: Same-Track Procedures and Dedicated Requirements

1. Key takeaways

In vitro diagnostic devices (IVDs) register on the same track as medical devices in Kazakhstan, applying the same Order No. ҚР ДСМ-16 and the same expert review procedures, but with dedicated requirements at three points: classification (under Order No. ҚР ДСМ-281/2020 and the IVD-specific rules of Decision No. 173 at Union level, with the treatment of these categories updated by Amendment No. 18 of February 18, 2025), samples and stability evidence (shelf life, shipping and storage condition verification for reagent products), and clinical evidence (the combined package of analytical and clinical performance data). The most common bottleneck in IVD projects is not the procedure itself but the preparation of sample and stability materials. Reagent kits cannot be summoned quickly: their production lots, shipping conditions and remaining shelf life all constrain the laboratory study calendar, and a delay in any one of them propagates directly into the expert review timeline. Because the expert center procures or receives samples under defined rules, sample logistics should be treated as a critical-path workstream with its own owner, rather than as an administrative afterthought to dossier writing.

2. Legal basis

3. Expert insights

Insight one: IVD classification was specifically adjusted in 2025, so old conclusions must be re-verified. Amendment No. 18 of February 18, 2025 adopted by the Eurasian Economic Commission Executive Board adjusted the treatment of software and IVD products within Decision No. 173. Every IVD classification conclusion formed before 2025 should be re-checked against the new criteria, particularly for companion diagnostics, self-testing products and blood screening products, where the risk of a class shift is highest. A classification change after submission invalidates the evidence plan, so the re-check is best performed before commissioning any new testing.

Insight two: whether reagent and instrument are integrated or separated determines the dossier structure. Reagents and their paired instruments can be registered separately or registered together as a system. The choice drives the future frequency of variations: with separate registration, an instrument software upgrade and a reagent formulation change proceed without touching each other; with system registration, any change on one side may require an assessment of its impact on the other. The decision should therefore be made on projected change frequency and commercial structure, not on submission convenience alone, and once made it should be recorded in the project file with its rationale.

Insight three: stability evidence is the most underestimated part of an IVD project. The shelf life of a reagent, in-use stability, shipping stability and storage condition verification together form a distinct evidence set. The review checks whether the remaining shelf life of the samples satisfies the study period requirement, and it also checks the consistency between the stability conclusions and the label claims. The GRZAN experience is that stability studies must be scheduled before sample shipping, not after the samples have arrived, because the clock on remaining shelf life runs from manufacture and cannot be paused while the dossier waits.

Insight four: measuring devices may additionally fall within metrology control. IVD instruments with measurement functions, such as blood glucose meters and biochemical analyzers, must also be assessed against the type approval and state registration requirements under the law on ensuring the uniformity of measurements. This is an independent compliance track that runs in parallel with device registration and carries its own evidence and timeline, so it must be planned alongside rather than after the registration project. The evidence demanded by the two regimes also differs: registration looks at analytical and clinical performance, while metrology looks at measurement accuracy and traceability of reference values, so a single combined study rarely satisfies both and the two evidence sets should be built deliberately.

4. Practical recommendations

1. After Amendment No. 18 of February 18, 2025 takes effect, re-verify the classification conclusions of all existing IVD products in the portfolio.
2. At project initiation, decide between separate registration of reagents and instruments or system registration, and assess the resulting future variation frequency.
3. Schedule stability studies before sample shipping, and confirm that the remaining shelf life of samples covers the full study period including any buffer for review questions.
4. For measuring instruments, verify the metrology type approval and state registration requirements in parallel.
5. File analytical performance and clinical performance evidence in separate volumes so that reviewers can retrieve each set without searching a mixed file.

5. Verification checklist

• □ IVD classification has been re-verified against the criteria after Amendment No. 18 of February 18, 2025
• □ The registration structure for reagents and instruments (separate or system) is decided
• □ Shelf life, in-use stability, shipping stability and storage condition verification are complete
• □ The remaining shelf life of samples covers the study period
• □ Metrology type approval requirements for measuring instruments have been checked
• □ Analytical and clinical performance evidence are filed in separate volumes

GRZAN provides registration support in Kazakhstan for manufacturers, importers and authorized representatives, covering IVD classification, stability evidence planning and expert review follow-up. For assistance, contact info@grzanglobal.com.

Regulatory information verified as of October 29, 2026.