Kazakhstan Medical Device Market Sampling: Order ҚР ДСМ-323/2020 and Follow-Up Paths

1. Key takeaways

Market sampling of medical devices in circulation in Kazakhstan is governed by Order No. ҚР ДСМ-323/2020 of the Minister of Health, which approves the Rules for Sampling Medicines and Medical Devices in Circulation. The regulator may draw samples from the market for laboratory testing, and companies bear a duty to cooperate. If sampling results show nonconformity, the consequences travel along three paths: corrective action (on-site correction or recall), inspection (an unplanned inspection under Decision No. 106), and registration certificate action (suspension or revocation). Sampling and retesting records must be able to cross-reference the adverse event ledger, and together the two form the evidence network of post-market compliance that a company can present during any regulatory review or inspection.

2. Legal basis

3. Expert insights

Insight 1: sampling happens in circulation, so samples come from the market rather than the factory. This fact determines two things. First, the company cannot control the storage and transport history of the samples, because what products experienced on the market cannot be traced back fully. Second, the object being tested is the real quality of the product as sold, not the quality of specially prepared submission samples, so internal release testing alone will never predict the outcome of a market sample. Storage conditions, handling and shelf life all enter the result, which is precisely what the regulator intends to examine.

Insight 2: the duty to cooperate has three layers. Providing the necessary documents and information, cooperating with the sampling procedure, and responding to the test results. A failure in any one of the three layers will be recorded as non-cooperation, and that record influences subsequent inspection ratings and any action taken against the registration certificate. Companies should therefore treat a sampling visit as a formal regulatory procedure with named owners for each layer of the duty. The document layer in particular should be pre-assembled, because technical files, batch records and distribution data are hard to gather on demand.

Insight 3: a nonconforming result travels along three paths. Along the corrective action path it enters on-site correction or recall; along the inspection path it triggers an unplanned inspection under Decision No. 106 to confirm that the causes leading to nonconforming devices leaving the factory have been eliminated; along the registration certificate path it enters suspension or revocation proceedings. The three paths can be launched at the same time, so a company cannot sequence them one after another but must assess them in parallel. Each path has its own clock, its own evidence requirements and its own decision owner, which is why a single coordinator is needed from the first notification.

Insight 4: sampling records and the adverse event ledger must be able to reference each other. Event investigations often need sampling and retesting to confirm whether a problem is batch-specific; in reverse, a nonconformity found through sampling may reveal events that were not previously identified. The two sets of records should be built with a cross-index from the start, so that either line of evidence can be produced with its counterpart during an inspection or a regulatory inquiry. Companies that wait until an event to build this linkage usually find that the two records cannot be reconciled without significant effort.

Insight 5: Order No. ҚР ДСМ-154/2020 is a separate source rule for samples. That order governs the procurement of samples for the purpose of expert review. It is a different sampling pathway from market sampling, with its own procedures and its own use. Companies should keep the two pathways distinct in their procedures and records, because the purpose, the custody rules and the downstream consequences of the samples are not the same. Conflating them in a response letter creates confusion about which rules the company believes apply.

4. Practical recommendations

1. Establish a sampling response process that makes the three layers of the cooperation duty explicit: documents, procedure and response to results.
2. Build a cross-index between sampling records and the adverse event ledger so the two can be referenced in both directions.
3. When a nonconforming result appears, assess the three transmission paths (corrective action, inspection, registration certificate action) in parallel.
4. Maintain a complete batch traceability chain so the destination of the same batch can be located quickly in a sampling event.
5. Keep the two pathways distinct: market sampling under Order No. ҚР ДСМ-323/2020 and review procurement under Order No. ҚР ДСМ-154/2020.

5. Verification checklist

• □ A sampling response process is in place and the three layers of the cooperation duty are defined
• □ A cross-index between sampling records and the adverse event ledger has been established
• □ An assessment mechanism for the three transmission paths of a nonconforming result has been established
• □ The product batch traceability chain is complete and can locate the destination of the same batch quickly
• □ The two sampling pathways, market sampling and review procurement, have been distinguished
• □ Retesting conclusions and corrective action records have been archived

Regulatory information verified as of October 29, 2026.

GRZAN provides registration and post-market compliance support for medical device manufacturers, importers and authorized representatives in Kazakhstan, including sampling response, laboratory follow-up and corrective action management. For inquiries, contact info@grzanglobal.com.