Kazakhstan Medical Device Regulatory Authorities: Ministry of Health, KMFK and NCELSMI

1. Key takeaways

Medical device regulation in Kazakhstan is a three-layer structure. The Ministry of Health of the Republic of Kazakhstan issues ministerial orders and adopts the rules governing registration. The Committee for Medical and Pharmaceutical Control of the Ministry of Health (КМФК) is the competent authority: it makes registration decisions, conducts supervisory inspections and manages the national register. The National Center for Expertise of Medicines and Medical Devices (НЦЭЛСМИ) is the technical review body under the Committee, responsible for the technical execution of expert review, laboratory studies and manufacturing site inspections. In practice, almost all technical interaction between a company and the authorities takes place with НЦЭЛСМИ, while decision-making power rests with КМФК and the Ministry of Health. Understanding this division of labour before submission avoids misdirected correspondence, duplicated requests and avoidable delays, because queries about testing belong with the expert center while questions about certificates, administrative files and official status belong with the Committee and the Ministry. The Code of the Republic of Kazakhstan on the Health of the People and the Healthcare System provides the statutory foundation for this allocation of powers, and the ministerial orders listed below define the operational detail: which body defines the competent authority and the expert organization, how expert assessment of safety, quality and efficacy is organized, and which cases trigger entry in the national register. Foreign manufacturers should map all three bodies at project start, because correspondence routed to the wrong layer is typically redirected rather than answered, and each redirection consumes weeks of calendar time in a schedule that is already compressed by the transition deadlines described elsewhere in this guide.

2. Legal basis

3. Expert insights

Insight one: rule-making and technical execution run on separate tracks. Ministerial orders are issued by the Ministry of Health, review and inspection are executed by НЦЭЛСМИ, and registration decisions and supervision are made by КМФК. In projects this produces a visible division: answers to technical questions come from the expert center, while administrative documents are issued by the Committee. Mixing the two communication channels into a single thread is a common source of lost time, because each body will simply redirect the enquiry to the other, and the redirected message usually loses its attachments and context along the way. GRZAN therefore separates technical correspondence from administrative correspondence at project start, assigns a named owner to each channel and keeps both trails separately archived so that any later dispute about who said what can be resolved from the record.

Insight two: the same order governs medicines and medical devices together. Order No. ҚР ДСМ-16 is by its title the state registration rules for medicines and medical devices, which means many procedural details of device registration share one framework with medicines. When Order No. 146 (November 18, 2025) amended that order, the arrangements on certificate validity and on medicines of strategic importance took effect along both the medicines and the devices tracks at the same time. Companies that read the amendment as a medicines-only change miss device-relevant consequences, particularly around what is entered in the national register and how existing certificates are handled.

Insight three: the expert center is also the organizer of testing and inspections. Under Order No. ҚР ДСМ-10, the organization of preliminary expertise, specialized expertise, laboratory studies of samples and manufacturing site inspections all sits with the expert organization. Scheduling must therefore account for the availability of three resources at once: the review queue, the laboratory calendar and the inspection team’s travel plan, rather than counting only the statutory review period. A project that models just the review timeline will systematically underestimate its completion date, because laboratory capacity and inspection logistics are frequently the binding constraints.

4. Practical recommendations

1. Maintain a two-channel contact map: route technical queries to the НЦЭЛСМИ project team, and route administrative documents and status tracking to КМФК, with named counterparts on each channel so that no enquiry sits unassigned.
2. Archive all submitted document versions and official receipts under a unified numbering system, so that any file can be traced as it circulates between the authorities and any discrepancy can be reconstructed from the record.
3. Manufacturing site inspections are organized by the expert center; complete internal self-inspection, corrective actions and documentation preparation before requesting an inspection date, because a failed or postponed inspection consumes a new slot in the inspection team calendar.
4. For disputes involving the interpretation of rules, rely on the text of the ministerial order and, where necessary, submit a written enquiry to the competent authority through the authorized representative, keeping the reply in the dossier as an authoritative interpretation record.

5. Verification checklist

• □ The technical counterpart body (НЦЭЛСМИ) and the administrative decision body (КМФК) for this project are clearly identified
• □ Submission receipts and document version numbers correspond one to one and remain traceable
• □ The three schedules for expert review, laboratory studies and site inspection have each been separately confirmed
• □ The authorized representative’s contact details are registered in the dossier and remain valid
• □ Divergences on rule interpretation are documented in written enquiry records
• □ All correspondence templates distinguish technical enquiries from administrative submissions before first use

GRZAN provides registration support in Kazakhstan for manufacturers, importers and authorized representatives, covering authority liaison, dossier preparation, expert review follow-up and inspection readiness. For assistance, contact info@grzanglobal.com.

Regulatory information verified as of October 29, 2026.