Kazakhstan Medical Device Risk Classification: Classes 1, 2A, 2B and 3

1. Key takeaways

Medical device classification in Kazakhstan uses a four-class system: Class 1 (low risk), Class 2a (medium-low risk), Class 2b (medium-high risk) and Class 3 (high risk). The classification outcome functions as a master switch: it simultaneously determines the depth of expert review, the scope of technical testing and toxicological studies, whether a manufacturing site inspection is required, and the coverage of that inspection. Classification is determined under Order No. ҚР ДСМ-281/2020 of the Minister of Health for the national pathway, while the Eurasian Economic Commission Executive Board Decision No. 173 (December 22, 2015, as amended by No. 65 in 2023 and No. 18 in 2025) applies for the Union pathway. A wrong classification decision forces the entire evidence package to be rebuilt, which makes misclassification the most expensive category of rework in a Kazakhstan project. Because the class drives every downstream resource decision, from laboratory budgets to inspection logistics, the classification conclusion should be documented, reviewed and frozen before any testing is commissioned. Once the class is fixed, the remaining planning variables fall into place: the number and depth of laboratory studies, the format of the clinical evidence, and the inspection expectations can each be budgeted with a known risk profile instead of provisional ranges.

2. Legal basis

3. Expert insights

Insight one: two sources of classification rules, and choosing the pathway means choosing the classification basis. On the Kazakh national pathway, classification is determined under Order No. ҚР ДСМ-281/2020; on the Union pathway, it is determined under Decision No. 173. Both systems use a four-class structure, but the detailed rules differ, particularly for software and for in vitro diagnostic devices, and the amendment No. 18 of February 18, 2025 was aimed precisely at adjusting the treatment of these two categories. The GRZAN approach is to fix the pathway first and the classification second, because applying Union criteria to a national dossier, or the reverse, produces a classification statement that does not survive review and must be rewritten at the cost of schedule and credibility.

Insight two: the class determines the strength of evidence, not merely the number of documents. Taking manufacturing site inspections as an example, under Decision No. 106 the evaluation of the quality management system is mandatory for Class 2a sterile, Class 2b and Class 3 devices, while Class 1 and non-sterile Class 2a devices generally fall outside mandatory inspection. This boundary moves the project timeline directly: an inspection can take up to 90 working days and the period is not counted within the review timeline. Budgeting for a Class 2b project without a full inspection window therefore produces plans that fail the first time the inspection calendar is confirmed.

Insight three: sterility is an independent classification variable. Devices with the same intended use may attract different inspection requirements depending on whether they are supplied sterile or non-sterile. When planning a product family, managing sterile status as an independent dimension prevents two different compliance cost structures from emerging inside one model family. This practical estimate also simplifies change control, because the consequences of a packaging or sterilization change become predictable across the family rather than case by case.

Insight four: classification must be frozen before submission, not adjusted on the way. The classification conclusion is written into the classification section of the registration dossier and is bound to the review pathway, the test program and the inspection scope. Changing the classification during review is equivalent to restarting project initiation. GRZAN recommends locking the conclusion with a written classification statement before formal submission, including the rule provisions relied on and a comparison against similar classified products. That statement then becomes the anchor for every later conversation with the reviewer: when a question arises about test scope or inspection depth, the answer is traced back to the class and the rule provision rather than renegotiated case by case, which keeps the project defensible and the schedule intact.

4. Practical recommendations

1. At project initiation, issue a written classification statement citing the applicable rule provisions and listing comparable products with their assigned classes.
2. Re-verify the classification of software and in vitro diagnostic products after Amendment No. 18 of February 18, 2025, since prior conclusions may no longer match the current criteria.
3. Predict inspection needs along the two dimensions of class and sterile status, and reserve an inspection window of up to 90 working days in the project plan.
4. Where a model family contains configurations spanning several classes, prepare the evidence package to the highest class represented in the family, and record the mapping of each configuration to its class so that later additions can be placed without reopening the analysis.

5. Verification checklist

• □ The pathway (national or Union) is chosen and the classification basis rule is selected accordingly
• □ The classification statement cites the determining provisions and comparable products
• □ Sterile status is marked as an independent dimension
• □ Whether a manufacturing site inspection is triggered has been predicted from the class
• □ Cross-class configurations within the model family are prepared to the highest class
• □ The software and IVD criteria after Amendment No. 18 of February 18, 2025 have been re-checked

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

Regulatory information verified as of October 29, 2026.