Kazakhstan Unregistered Medical Device Import: Three Permitted Channels

1. Key takeaways

Kazakhstan provides three channels for importing and using unregistered medical devices: exhibition samples, displayed at trade events without the right to sell; research and development items, used for study and development; and critical care imports, permitted by the competent authority to save the lives of patients. Each channel carries its own document requirements and use restrictions, the channels are not interchangeable, and goods imported under them must not be converted to sale. At the Union level, the protocol signed on February 9, 2026 further added devices imported with permission of the competent authority to save lives, and custom-made devices manufactured to the order of an individual patient, to the list of exemptions from registration. None of these channels replaces registration for routine commerce; they are narrow instruments with defined purposes, and every shipment should be mapped to exactly one of them before documents are prepared.

2. Legal basis

3. Expert insights

Insight one: the common feature of the three channels is that use ends when the purpose is fulfilled. Exhibition samples must be re-exported after the event or disposed of according to the rules; research items may only be used for study; critical care devices may only be used for the specific patient. None of the channels allows conversion to commercial sale, and disposal records are a necessary part of closing the compliance loop. As a practical estimate, the disposal record should be created at the moment the purpose is fulfilled, not reconstructed later, because retrospective records are the weakest evidence in any authority review.

Insight two: the trigger condition for the critical care channel is permission of the competent authority. The protocol signed on February 9, 2026 added to the Union exemption list devices brought across the customs border of the Union, with permission of the competent authority, to provide patients with life-saving medical care. The corresponding procedure on the Kazakhstan side is carried by Orders No. ҚР ДСМ-237/2020 and No. ҚР ДСМ-280/2020, and in practice requires cooperation between the healthcare institution and the competent authority at both ends. The medical case file, the clinical justification and the import documents should tell one consistent story, because the authority will verify that the import matches the declared emergency.

Insight three: the value of the exhibition sample channel is that the absence of a right to sell is expressly recognized. This means that participating in a medical device exhibition in Kazakhstan does not require holding a registration certificate first. For manufacturers entering the market for the first time, this is an important low-threshold entry point. Exhibitions also generate user feedback and distributor contacts that feed the registration project, so the two workstreams reinforce each other when the sample paperwork is handled correctly.

Insight four: the research channel can connect with the registration channel. If a research item later becomes a registration sample, its purpose and disposal records must be internally consistent. GRZAN recommends considering possible later conversion of use at the initial application and leaving room in the application materials for such a statement. As a practical estimate, a single consistent purpose narrative from the first application onward is far cheaper than attempting to reconcile two conflicting stories after the fact.

Insight five: exemption from registration does not exempt other compliance requirements. Exemption from registration does not mean exemption from oversight: samples still require an import permit, may still engage metrology and electromagnetic compatibility tracks among others, and must still be used for the declared purpose. Reading exemption from registration as exemption from all formalities is a dangerous misreading. The exemption removes the need for a registration certificate, not the need for paperwork, and every other obligation that attaches to devices in circulation continues to apply to exempt shipments.

4. Practical recommendations

1. Prepare materials separately for the three channels, stating purpose, quantities and disposal method, and never mix documents.
2. For the critical care channel, engage the healthcare institution and the competent authority early and obtain written permission.
3. Plan the re-export or compliant disposal of exhibition samples in advance of the event.
4. If research items may later become registration samples, leave room in the initial application for a change of use.
5. For imports exempt from registration, still check the requirements of other tracks such as metrology and technical regulation.

5. Verification checklist

• □ The import purpose has been clearly classified as exhibition, research or critical care
• □ The import permit has been applied for under the corresponding channel without mixed documents
• □ Written permission of the competent authority has been obtained for critical care cases
• □ A re-export or disposal plan for exhibition samples has been prepared
• □ The possibility of converting the use of research items is reflected in the application materials
• □ The requirements of other tracks such as metrology and technical regulation have been checked
• □ The restriction that exempt imports must not be converted to sale has been communicated to frontline staff

Regulatory information verified as of October 29, 2026.

GRZAN provides registration support in Kazakhstan for medical device manufacturers, importers and authorized representatives, including import permits for unregistered devices and channel compliance planning. Channel classification is documented per shipment before documents are prepared. For inquiries, contact info@grzanglobal.com.