Kazakhstan Medical Device Registration Exemptions: Union List and National Channels

1. Key takeaways

Kazakhstan’s exemptions from registration come from two levels: the exemption list in Article 4 of the 2014 Agreement at Union level, and national Kazakh channels for specific purposes such as exhibition samples, research prototypes, emergency life-saving treatment and exceptional use of unregistered devices. The protocol signed on February 9, 2026 added four categories of exemptions at Union level: custom-made devices manufactured to the order of an individual patient, devices imported under competent authority permission to save lives, devices manufactured within a member state exclusively for export, and combination packs and first-aid kits composed of registered devices together with medicines. An exemption does not mean an absence of supervision: every channel carries explicit purpose restrictions and documentation requirements, and goods admitted under an exemption generally cannot be redirected to ordinary commercial sale. Because the exemption channels and the registration pathway serve different purposes, mixing their documentation or treating an exemption as a low-cost substitute for registration is a direct route to customs and supervisory problems.

2. Legal basis

3. Expert insights

Insight one: the exemption list operates by enumeration, so anything not listed requires registration. The list works by item-by-item enumeration, which means the decision method is comparison, not inference. When evaluating a new product, compare it against each item of the most recent version of the list rather than relying on the experience that a similar product was once exempted. A close-but-not-identical product is not exempt, and a precedent created under an older version of the list does not survive an amendment. GRZAN records the comparison row by row and keeps it in the project file as the basis for the scoping conclusion.

Insight two: the custom-made device exemption is strictly limited to the person and the order. Only devices manufactured to the order of an individual patient and intended solely for that patient’s personal use fall within the exemption. Products manufactured in batches and then configured to patient parameters do not qualify as custom-made devices and still require registration. The distinction turns on when the specification is fixed: in genuine custom manufacture the specification exists only because of the individual order, whereas in batch production with configuration the specification already exists and the patient merely selects among options.

Insight three: the export-only exemption is for manufacturers located within member states. Devices manufactured within a member state and exclusively for export are exempt from Union registration. This provision offers limited direct value to manufacturers based outside the Union, but it becomes relevant when structuring production and registration arrangements with local partners in Kazakhstan, because a locally based line dedicated to export markets can operate without Union registration while the same product sold domestically cannot.

Insight four: the import and use of unregistered devices in Kazakhstan runs on separate channels. Order No. ҚР ДСМ-237/2020 provides the state service for licences to import unregistered medicines and medical devices, while Order No. ҚР ДСМ-280/2020 governs the exceptional use of unregistered devices. Exhibition samples, research prototypes and emergency life-saving treatment each carry their own documentation requirements, and the same set of papers cannot be reused across the three situations. Preparing per-channel files from the start avoids rejections at the licence stage.

Insight five: the protocol of February 9, 2026 is pending completion of domestic procedures by member states. The protocol is signed but its status of application depends on each member state’s ratification progress. In Kazakhstan projects, any reliance on the newly added exemption categories must be accompanied by verification of the protocol’s status of application in Kazakhstan, which remains pending verification until national procedures conclude.

4. Practical recommendations

1. At project initiation, compare the product against the latest version of the exemption list item by item and keep the comparison record.
2. In the justification file for a custom-made device, state both required elements explicitly: manufacture to the order of an individual patient, and use solely for that patient.
3. Prepare the exhibition sample, research prototype and emergency treatment channels separately, stating the purpose and the disposal method in each application.
4. Before relying on any new exemption category introduced by the protocol of February 9, 2026, verify its status of application in Kazakhstan.
5. Devices imported under an exemption must not be diverted to sale; state the disposal method in the application material and keep records of the actual disposal afterwards.

5. Verification checklist

• □ The latest version of the exemption list has been compared item by item and the comparison record is retained
• □ For custom-made devices, the elements of individual patient order and personal use only are stated in the justification
• □ Import of unregistered devices is licensed under Order No. ҚР ДСМ-237/2020
• □ Use of unregistered devices conforms to the exceptional situations in Order No. ҚР ДСМ-280/2020
• □ The status of application of the protocol of February 9, 2026 in Kazakhstan has been verified
• □ The purpose and disposal method of exemption-imported devices are documented and traceable

GRZAN provides registration support in Kazakhstan for manufacturers, importers and authorized representatives, covering exemption analysis, licence applications and customs documentation. For assistance, contact info@grzanglobal.com.

Regulatory information verified as of October 29, 2026.