Kazakhstan Medical Device Sample Import Permit under Order No. ҚР ДСМ-237/2020

1. Key takeaways

A medical device without a Kazakhstan registration certificate cannot clear customs through the ordinary commercial route; samples intended for registration purposes rely on the dedicated channel established by Order No. ҚР ДСМ-237/2020 of the Ministry of Healthcare, dated December 8, 2020, registered with the Ministry of Justice under No. 21749. This order sets the rules for the movement of medicines and medical devices across the state border and provides a state service: the issuance of permits, as conclusive documents, for the import and export of registered and unregistered medicines and medical devices. Sample clearance and commercial clearance run on two separate documentation systems, and mixing them is the main reason samples get stuck at customs. As a practical estimate, the permit route should be treated as the default for every shipment that does not yet have a registration certificate, regardless of shipment size or declared value.

2. Legal basis

3. Expert insights

Insight one: the import permit is a state service with a defined procedure and document requirements. The state service provided under Order No. ҚР ДСМ-237/2020 is expressly titled as the issuance of permits for the import and export of registered and unregistered medicines and medical devices. This means there is a lawful channel for importing unregistered devices, rather than leaving companies to improvise. Applying through the procedure is the only reliable approach. The service exists precisely because the examination system needs samples of products that are not yet registered, so the authority has a structured interest in handling such shipments properly.

Insight two: the documentation systems for sample import and commercial import are completely different. Commercial clearance relies on the registration certificate and ordinary trade documents; sample clearance relies on the import permit and a statement of purpose, such as expert examination, exhibitions or research and development. Applying commercial documents to samples, or the reverse, will block clearance. Freight forwarders should be briefed in writing on which regime each shipment uses, because forwarders often reuse document templates from previous shipments and that habit is a frequent source of mismatch at the border.

Insight three: the purpose and disposal method of samples must be stated at the time of application. An import permit application must describe the purpose of the samples, whether examination, exhibition or research and development, and the quantities; the disposal after import must also be recorded. Order No. ҚР ДСМ-154/2020 separately governs the procurement of samples for expert examination, and the two rules are applied in sequence. In practice this means the disposal record started at the border should follow the sample all the way into the examination process, so that every unit can be accounted for at the end of the review.

Insight four: remaining shelf life and transport conditions must be managed from the import stage onward. The examination imposes requirements on the remaining shelf life of samples, normally not less than six months, and every segment from production, dispatch and clearance to warehousing consumes time. Delays at the import stage directly erode the remaining life, so the permit application should build in lead time. As a practical estimate, manufacturers should work backward from the intended examination start date, subtracting production, dispatch, transit and clearance time, and confirm with the laboratory how the remaining shelf life will be measured on receipt.

Insight five: the marking interface at the import stage must be confirmed in advance. Order No. ҚР ДСМ-11 sets the rules for labeling and traceability of medicines and the rules for marking of medical devices. Whether identification codes must be provided at import should be confirmed with the competent authority before dispatch, to avoid supplementing documents after arrival at port.

4. Practical recommendations

1. Route all sample imports through the permit channel of Order No. ҚР ДСМ-237/2020 and never mix documents with commercial clearance.
2. State the purpose, quantities and disposal method of the samples in the application and retain disposal records.
3. Start the permit application early, reserving time for production, dispatch and clearance to protect the remaining shelf life of samples.
4. Before dispatch, confirm whether identification codes must be provided at import, in line with Order No. ҚР ДСМ-11.
5. Record transport and storage conditions of samples throughout, as part of the examination material.

5. Verification checklist

• □ The import permit under Order No. ҚР ДСМ-237/2020 has been obtained for the sample import
• □ The application states the purpose, quantities and disposal method of the samples
• □ Disposal records of the samples have been retained
• □ The permit application timeline accounts for the remaining shelf life, recommended at not less than six months
• □ The marking requirements at the import stage have been confirmed
• □ Records of transport and storage conditions of the samples are complete

Regulatory information verified as of October 29, 2026.

GRZAN provides registration support in Kazakhstan for medical device manufacturers, importers and authorized representatives, including sample import permits and clearance coordination. Shipment-specific document sets are prepared to keep sample and commercial regimes strictly separated. For inquiries, contact info@grzanglobal.com.