Kazakhstan Medical Device Marking and Traceability: Order ҚР ДСМ-11 and the IS MPT System

1. Key takeaways

The marking and traceability rules for medical devices in Kazakhstan are established by Order No. ҚР ДСМ-11 of the Minister of Health (January 27, 2021, Ministry of Justice registration no. 22146), and after amendment by Order No. ҚР ДСМ-49 (May 30, 2022, Ministry of Justice registration no. 28315) they were split into Annex 1 on medicines traceability and Annex 2 on medical device marking. The mandatory timetable on the medicines side is already fixed (100% marking from July 1, 2024, serialization of prescription medicines from January 1, 2025, serialization of over-the-counter medicines from July 1, 2025); for medical devices there is still no official regulation specifying the mandatory effective date. The correct posture is rules established, timing pending verification, with GTIN allocation and preparation for connection to IS MPT (the goods identification and traceability information system) completed ahead of time.

2. Legal basis

3. Expert insights

Insight 1: Order No. ҚР ДСМ-49 separated the rules for medicines from the rules for devices, which is the key structural change. The amendment of May 30, 2022 changed the title to the Rules for Marking and Traceability of Medicines and the Rules for Marking of Medical Devices, and regulated the two fields separately through Annex 1 on medicines traceability and Annex 2 on device marking. This means device marking and medicines traceability are two distinct rule sets, and citations must not mix the annexes. A document that cites the wrong annex is a defective citation in any regulatory correspondence. Companies should update their internal procedure references and templates now, since legacy wording citing the pre-amendment title is still in circulation in many contract and quality documents.

Insight 2: the mandatory timetable on the medicines side has three dates; the device side has no corresponding dates yet. Medicines: 100% marking from July 1, 2024, serialization of prescription medicines from January 1, 2025, and serialization of over-the-counter medicines from July 1, 2025, under Government Resolution No. 516. Devices: Annex 2 has established the marking rules, but no official regulation states the mandatory effective date. The practical estimate of GRZAN is rules established, timing pending verification, and preparation is organized on that basis with a quarterly review checkpoint. The medicines timetable is itself the best indicator of direction, since the same infrastructure and operator serve both product classes.

Insight 3: the recipient of traceability data is IS MPT. The goods identification and traceability information system is operated by the national operator and handles serialization issuance, commissioning and the registration of circulation events. Corporate IT systems must be able to generate data to GS1 standards and submit it to this system. Connection therefore involves both a regulatory registration step and an engineering project, and the engineering lead time is the part most often underestimated. Testing the data flow with a small product line before the mandatory date is a low-cost way to de-risk the full rollout.

Insight 4: coding is the prerequisite work for marking and should start during the registration stage. The marking code uses GS1 DataMatrix and carries application identifiers including the GTIN (AI 01) and the serial number (AI 21). GTIN allocation must be consistent with the product information in the registration dossier, so coding work should proceed in parallel with the registration submission rather than being patched on after certification, when every change would need to be reconciled against the approved dossier. Early allocation also protects packaging artwork timelines, which depend on the final codes being fixed before printing.

Insight 5: the import stage also has marking linkage requirements. The import rules of Order No. ҚР ДСМ-237/2020 already refer to marking linkage when medicines, including unregistered medicines, are imported. Before import, companies should confirm whether an identification code must be provided, so that shipments do not arrive at port and then stall while missing documents are produced. Devices should be assessed against the same logic as the rules converge over time.

4. Practical recommendations

1. When citing the rules, distinguish Annex 1 on medicines traceability from Annex 2 on device marking and never mix the two.
2. Start GTIN allocation during the registration stage and keep it consistent with the product information in the dossier.
3. Assess the IT workload for IS MPT connection early, and reserve a preparation period on the basis of rules established, timing pending verification.
4. Keep tracking the mandatory effective date for device marking and set a quarterly review checkpoint.
5. Before import, confirm whether an identification code must be provided to avoid missing documents at port.

5. Verification checklist

• □ The applicable rules have been distinguished between Annex 1 (medicines traceability) and Annex 2 (device marking)
• □ GTINs have been allocated to GS1 standards and match the product information in the registration dossier
• □ The IT assessment for IS MPT connection has been completed
• □ The mandatory effective date for device marking has been entered on a quarterly tracking list
• □ The marking linkage requirements at the import stage have been confirmed
• □ Submission flows for serialization and circulation events have been designed

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 marking and traceability readiness, GTIN planning and IS MPT connection preparation. For inquiries, contact info@grzanglobal.com.