EAEU Medical Device Registration via Kazakhstan: Reference States and Recognizing States

1. Key takeaways

The Eurasian Economic Union registration system operates through reference-state review plus recognition by recognizing states. The applicant designates one member state as the reference state (референтное государство), whose competent authority leads the technical evaluation, and designates at least one member state as a recognizing state (государство признания), which then approves or rejects the expert conclusions of the reference state. Once approved, the product enters the union unified register and circulates in the markets of all member states. Within the union framework, Kazakhstan’s Ministry of Health acts as the competent authority, and the National Center for Expertise of Medicines and Medical Devices (НЦЭЛСМИ) provides technical evaluation support; Kazakhstan can participate both as a reference state and as a recognizing state. In addition, Kazakhstan retains its own national registration track until December 31, 2027, so registrants face a genuine two-track landscape in which the choice of route, the choice of reference state and the sequencing of filings all interact and should be planned as a single portfolio decision. Because the reference state drafts the conclusions that every recognizing state later judges, the quality of the initial dossier pays off five times over.

2. Legal basis

3. Expert insights

Insight one: the choice of reference state is the first strategic decision of the union route. The reference state’s competent authority performs the technical evaluation and drafts the expert conclusions, and its review style, depth of questioning and inspection scheduling capacity directly shape the pace of the project. In practice, Russia and Kazakhstan are the member states most frequently acting as reference states. When choosing, weigh three factors together: the weight of the target markets, the scheduling capacity for manufacturing inspections, and the language and communication cost. A reference state chosen for convenience at the start can either accelerate or stall every subsequent stage of the same project. Where the target markets are concentrated in one or two members, choosing those members as recognizing states also shortens internal communication.

Insight two: recognizing states do not rubber-stamp the conclusions. The recognizing state’s competent authority approves or rejects the expert conclusions of the reference state, and this stage generates its own questions and supplementary material requests. Treating recognition as a formality is the most common cause of schedule overruns on the union route. GRZAN plans recognizing-state rounds into the calendar from day one and prepares answers to predictable questions in advance, because every unplanned remedy round in a recognizing state multiplies across all of them. Early alignment on the scope of the dossier, before the reference-state review even starts, reduces the volume of formal remedy rounds downstream.

Insight three: the initial manufacturing inspection is organized by the reference state. Under Decision No. 106, the initial inspection is conducted by the reference state’s competent authority at all manufacturing sites listed in the application; the inspection report is valid for 3 years from the date of issue; periodic inspections run every 3 years. This means the choice of reference state also binds inspection resources. If the reference state’s inspection calendar is congested, the entire union project inherits that congestion, which is why inspection scheduling capacity should be weighed when the reference state is selected.

Insight four: the uniform circulation mark is the external identifier of union registration. The union market uses a dedicated circulation mark, whose design and dimension requirements are set by Decision No. 26. Once the certificate is granted, label and packaging design must be adapted in step, and doing this concurrently with the review phase avoids a reprint cycle after grant.

Insight five: Kazakhstan’s role in the union system is dual. As a member state, Kazakhstan’s authorities participate in union procedures; at the same time, Kazakhstan retains its national registration track until December 31, 2027. A company’s positioning in Kazakhstan is therefore a portfolio exercise between one-shot national access and multi-country union coverage, and the two options can legitimately be combined across different product lines. For planning purposes, the December 31, 2027 date therefore also functions as the last day on which the cheapest national access to the Kazakhstan market can be secured.

4. Practical recommendations

1. Complete the choice of reference state at the project initiation stage, evaluating review style, inspection scheduling capacity and communication cost.
2. Determine the number of recognizing states according to the target market list; do not add unnecessary recognition steps for extra coverage.
3. The initial inspection covers all listed sites, so reserve time for every site when scheduling.
4. The inspection report is valid for 3 years; build a rolling periodic inspection plan around it.
5. After the grant, adapt labeling to the union uniform circulation mark (design and dimensions per Decision No. 26).

5. Verification checklist

• □ The reference state and recognizing states have been determined and the reasons are documented in writing
• □ The questions and supplementary material requests of recognizing states are included in the schedule
• □ All manufacturing sites listed in the application are confirmed and the initial inspection is being scheduled
• □ The 3 years validity of the inspection report is included in the periodic inspection plan
• □ The design and dimension requirements of the union uniform circulation mark have been adapted
• □ The combined plan for the Kazakhstan national route and the union route has been determined

GRZAN provides registration support in Kazakhstan for medical device manufacturers, importers and authorized representatives, covering union filings, reference-state and recognizing-state coordination, inspection preparation and post-grant registration maintenance. For assistance with this topic, contact info@grzanglobal.com.

Regulatory information verified as of October 29, 2026.