Kyrgyzstan Medical Device Registration: Reference States and Recognizing States in the EAEU Pathway

1. Key takeaways

The basic architecture of the union route is a two-layer structure of reference state plus recognizing states. The applicant selects one reference state, whose authorized body or expert organization performs the document review, carries out a manufacturing inspection where necessary, and issues the expert conclusion on safety, quality and efficacy; one or more recognizing states then approve that expert conclusion. The conclusion is issued by the reference state, and its effect is granted by the recognizing states — that is how one registration enabling circulation in multiple countries actually works. If member states disagree over an expert conclusion, the community of experts on medical devices, a consultative and deliberative body, handles the matter.

2. Legal basis

1. Eurasian Economic Commission Council Decision No. 46, February 12, 2016, Rules for the Registration and Expert Review of Medical Devices for Safety, Quality and Efficacy — the registration and expertise procedure of the union route.
2. Eurasian Economic Commission Council Decision No. 106, November 10, 2017 — manufacturing inspections and quality management system requirements.
3. Description of the functions of the community of experts on medical devices as published on the website of the competent authority (the Department of Medicines and Medical Devices under the Ministry of Health): the body was established under the Treaty on the Eurasian Economic Union (2014-05-29) and the Agreement of 2014-12-23, and its tasks include:
   • Considering disagreements between the reference state and recognizing states arising from the coordination of expert conclusions (with the applicant’s consent, authorized bodies or expert organizations of member states not listed as the reference or recognizing state may be given access to the materials);
   • Considering whether a product is a medical device, whether it should be classified as a measuring instrument, and classification questions by potential use risk class and type, referring unresolved items to the advisory committee;
   • Proposing improvements to union-level documents on device circulation.
4. Article 2 of Cabinet Resolution No. 513: under the national route, classification and general requirements are applied by reference to union decisions (the national route does not use the reference state mechanism).
5. Article 14 of Law No. 216 and Annex 1 to Cabinet Resolution No. 513: the national route procedure.

3. Expert insights

Insight one: the reference state is the lead reviewer of the entire union-route project.

The reference state carries the document review, the manufacturing inspection where necessary, and the issuance of the expert conclusion. Factors in selecting it include the match between the expert organization’s specialty and the product, access to testing laboratories, language and communication efficiency, and prior review experience with similar products. A wrong choice of reference state does not merely slow the project; it can result in a conclusion the recognizing states refuse to accept.

Insight two: recognizing states are not rubber stamps; they perform an independent approval action.

Each recognizing state approves the expert conclusion of the reference state, and this approval is an independent procedural step through which the recognizing state exercises its own authority. The practical implication: even with a favorable conclusion from the reference state, a recognizing state may still raise supplementary requirements. The project plan should reserve separate approval time for each recognizing state instead of merging all approvals into a single action.

Insight three: dispute mediation is a formal channel with an applicant-consent precondition.

One detail in the description of the expert community’s functions deserves attention: considering disagreements between the reference state and recognizing states requires the consent of the applicant (a manufacturer who is a resident of a member state, or its authorized representative), allowing authorized bodies or expert organizations of member states not listed as reference or recognizing state to access the materials. This reveals how mediation operates: the mediation process may require exposing the registration materials to experts from additional member states. When deciding whether to trigger mediation, companies must weigh the time benefit against the wider circulation of their materials.

Insight four: classification and product-status disputes have a unified resolution entry point at union level.

The second function of the expert community is to resolve disputes over whether a product is a medical device, whether it falls under measuring instruments, and the classification by risk class and type. This gives the union route a formal remedy for the combination-product status questions discussed in article 03. For products whose status or classification is contested, the union route actually offers an additional formal channel.

Insight five: under the union route, the authorized representative requirement is not waived.

As discussed in article 05, the manufacturer’s authorized representative must be a resident of the Kyrgyz Republic and bear responsibility. The same requirement applies under the union route: whichever pathway a foreign manufacturer chooses, an authorized representative must be designated within Kyrgyzstan. The assumption that the union route removes the need for a local entity is a common misconception.

4. Practical recommendations

First, select the reference state and recognizing states by ranking on two axes: market priority and review capability. List the member state with the largest expected sales as the reference state, since its review carries the greatest weight, list the others as recognizing states in order of market importance, and assess each state’s expert organization experience with comparable products.

Second, schedule each country separately. In the project plan, set distinct time milestones for the reference state review and for the approval of each recognizing state, and reserve a window for possible dispute mediation.

Third, decide in advance whether to consent to wider access to materials. Before launching the union-route project, determine internally whether, in the event of a disagreement among member states, experts from unlisted member states may access the materials. Record the decision in writing to avoid improvised decisions under time pressure.

Fourth, for products with contested status or classification, prefer the union route. If the product’s status as a device or measuring instrument, or its risk class, is disputed, the union route allows a unified conclusion to be sought through the expert community, avoiding inconsistent answers from different member states.

5. Verification checklist

• □ The combination of reference state and recognizing states is decided, with the selection rationale recorded (market priority plus review capability);
• □ The project plan sets separate time milestones for the reference state review and for each recognizing state approval;
• □ An internal decision on whether to allow experts from unlisted member states to access materials in case of disagreement has been made and recorded in writing;
• □ A manufacturer’s authorized representative who is a resident of the Kyrgyz Republic has been designated (also required under the union route);
• □ For products with contested classification or status, the feasibility of seeking a unified conclusion through the expert community has been assessed;
• □ Current texts of Eurasian Economic Commission Council Decision No. 46 (2016-02-12) and Decision No. 106 (2017-11-10) have been obtained.

Regulatory information verified as of October 29, 2026.

Our services cover: premarket pathway selection and feasibility assessment, registration dossier preparation and submission, authorized representative arrangements, local testing and clinical trial organization, manufacturing site inspection coordination, quality management system compliance support, post-market surveillance and vigilance system setup, import and distribution compliance, fee estimation and project budget management.

GRZAN provides regulatory registration support in Kyrgyzstan for medical device manufacturers, importers and authorized representatives, covering the full pathway from route selection to post-market obligations.

The GRZAN regulatory team consists of professionals with years of hands-on experience in Eurasian Economic Union registrations and maintains a stable local collaboration network in Bishkek, Almaty, Tashkent, Moscow and other cities, working in Chinese, Russian and English. We deliver actionable solutions for the issues foreign manufacturers most often encounter in the CIS region, including authorized representative arrangements, the notarization and legalization chain for powers of attorney, localization of technical documentation, and inspection readiness.

We hold to one principle: every regulatory conclusion we publish must rest on verifiable official sources. Figures and timelines that cannot be verified are labeled as a practical estimate, and experience-based values are never presented as legal requirements.

For project consultation on market access in Kyrgyzstan or the Eurasian Economic Union, contact us at info@grzanglobal.com.

GRZAN | Global Medical Device Regulatory Registration and Compliance Services