EAEU Decision No. 46: Key Points for Medical Device Registrants in Kazakhstan

1. Key takeaways

Decision No. 46 of the Board of the Eurasian Economic Commission, dated February 12, 2016, approving the Rules for Registration and Expert Evaluation of the Safety, Quality and Efficacy of Medical Devices, is the operating master text of the union route. Read it in four blocks: registration (applicant eligibility, dossier composition, reference-state and recognizing-state procedures), expert review (stages of review, questions and remedies, form of conclusions), inspection (triggers, organization and the effect of inspection conclusions for manufacturing site inspections), and changes (classification and procedures for changes to the registration dossier). Understanding these four blocks explains the fundamental difference between the union route and the Kazakhstan national route: the former is one evaluation approved by many states, while the latter is one evaluation approved by one state. That structural difference drives everything from the number of remedy rounds to the transmission time of changes, so it should shape how the dossier is written and how the project calendar is built from the very first day. Teams that map the four blocks against their own project calendar usually find that the review block, not the registration block, consumes the most elapsed time.

2. Legal basis

3. Expert insights

Insight one: the core output of the registration block is a dossier that works across borders. The union dossier shares its structure with the national one (technical documentation, risk management, labeling and instructions for use, a checklist against the general safety and efficacy requirements, clinical evaluation), but the evaluation system is cross-border: the same file must survive reference-state review and recognizing-state re-checks. This determines that the writing standard for a union dossier should be multi-country-reader-friendly rather than tailored to satisfy one reviewer. GRZAN drafts union dossiers so that a second authority can find every justification without a call to the sponsor, which is the cheapest way to shorten recognition rounds.

Insight two: the key variable in the review block is the length of the questioning chain. The union review is led by the reference state, while the recognizing states take their positions independently after receiving the expert conclusions. Questions can arrive from both ends, and remedy materials must satisfy both ends at once. GRZAN’s experience is that union projects typically run more remedy rounds than national projects; this is a consequence of the institutional structure, not a symptom of poor document quality, and budgets should be set accordingly. Building a question-and-answer log from the first reference-state round also makes the recognizing-state rounds faster, since many questions repeat between authorities.

Insight three: the inspection block is bound to Decision No. 106. The initial inspection is conducted by the reference state at all listed manufacturing sites, the conclusion report is valid for 3 years, and periodic inspections run every 3 years. Decision No. 131 of November 12, 2021 introduced the possibility of remote assessment, which provides additional scheduling flexibility when travel or calendar constraints would otherwise delay an inspection.

Insight four: the changes block is the main source of long-term cost. Union change procedures are transmitted between the reference state and the recognizing states, and a single non-approving recognizing state creates a delay for the change as a whole. When planning the cadence of product iterations, companies should factor in this transmission time, because a change that takes weeks nationally can take substantially longer when several authorities must align. Grouping minor iterations into fewer, larger change submissions reduces the number of transmissions between authorities and the cost that comes with each of them.

Insight five: Decision No. 27 is the technical baseline for dossier writing. The general safety and efficacy requirements, together with the labeling and operating documentation requirements, form the technical core of the dossier. National Kazakh dossiers and union dossiers overlap heavily in this block, which is precisely the foundation on which evidence packages can be reused between the two routes.

4. Practical recommendations

1. Write the union dossier to a multi-country-reader-friendly standard and anticipate in advance the follow-up angles of recognizing-state reviewers.
2. Reserve more time and budget for remedy rounds than a national project would need.
3. Schedule inspections on the basis that the reference state organizes them across all listed sites, and watch the remote assessment option under Decision No. 131.
4. Match the product iteration cadence to the transmission time of union changes and avoid frequent small revisions.
5. Use the general requirements of Decision No. 27 as the technical baseline for the dossier, so it can be reused across national and union routes.

5. Verification checklist

• □ The registration dossier is written to union standards and covers the checklist against the general safety and efficacy requirements
• □ The dual questioning mechanism of the reference state and recognizing states is included in the schedule and budget
• □ The manufacturing site inspection is scheduled as reference-state organized, covering all listed sites
• □ The 3 years validity of the inspection report is included in the periodic inspection plan
• □ The transmission time of union changes is included in product iteration planning
• □ The reuse relationship between national and union dossiers is clearly mapped

GRZAN provides registration support in Kazakhstan for medical device manufacturers, importers and authorized representatives, covering union dossiers under Decision No. 46, review follow-up, inspection coordination and post-grant registration maintenance. For assistance with this topic, contact info@grzanglobal.com.

Regulatory information verified as of October 29, 2026.