Kyrgyzstan Medical Device Registration Authority: The DSMI Department and the Electronic System

1. Key takeaways

The competent authority for state registration of medical devices in Kyrgyzstan is the Department of Medicines and Medical Products of the Ministry of Health of the Kyrgyz Republic (Департамент лекарственных средств и медицинских изделий, abbreviated as ДЛСМИ), whose official website is dlsmi.kg. All procedures for registration, dossier changes, suspension and revocation of registration certificates are handled in the department’s Information System of the Electronic Database of Medicines and Medical Products (ИС ЭБД ЛС и МИ). Chinese manufacturers need to remember two things: the receiving body is this department, and the submission vehicle is this electronic system.

2. Legal basis

1. Law of the Kyrgyz Republic On the Circulation of Medical Devices, No. 216 of December 29, 2023.
2. Cabinet Resolution No. 513 of August 27, 2024, approving Annex 1, the Procedures for State Registration, Assessment of Safety, Quality and Effectiveness, Maintenance of the National Register and Nomenclature, Changes to Registration Dossiers, and Suspension or Revocation of Registration Certificates.
3. Article 3 of Annex 1 to Cabinet Resolution No. 513: registration of medical devices is carried out by a subordinate unit of the authorized state body in the field of circulation of medicines and medical products of the Kyrgyz Republic.
4. Article 2 of Annex 1 to Cabinet Resolution No. 513: definitions of the applicant, the registration number, the authorized representative of the manufacturer and other concepts.
5. Public information published in the medical device section of the competent authority website: registration, change, suspension and revocation procedures are handled in the ИС ЭБД ЛС и МИ system, and five sets of forms are published, namely Annexes 1, 2, 3, 4 and 10.

3. Expert insights

Insight 1: the law locates the receiving body as a subordinate unit rather than an independent agency.

The wording of Article 3 of Annex 1 to Cabinet Resolution No. 513 is that registration is carried out by a subordinate unit of the authorized state body of the Kyrgyz Republic. This wording conveys a very practical message: the receiving body sits at the executive level within the Ministry of Health system and does not hold independent rule-making power. As a result, changes to procedural details — such as payment deadlines or form formats — usually appear through cabinet resolutions or internal departmental rules rather than through amendments to the law itself. Tracking this market requires more than watching the statutory text.

Insight 2: the electronic system is not an optional channel; it is the only vehicle.

The competent authority states clearly on its website that all procedures for registration, changes, suspension and revocation of registration certificates are handled in the ИС ЭБД ЛС и МИ system. This produces three practical consequences. First, document versions, timestamps and attachments all follow the system account, so ownership of the account equals ownership of responsibility. Second, a foreign manufacturer cannot hold the account itself; in practice the account is held by the authorized representative, which further reinforces the irreplaceable role of that representative. Third, deficiency letters and responses all leave an audit trail, and the starting point of the response period is determined by the system record rather than by over-the-counter handover.

Insight 3: the five published forms are the yardstick of project maturity.

The five forms published by the competent authority are: Annex 1, the registration application form; Annex 2, the application form for changes to the registration dossier; Annex 3, the revocation application form; Annex 4, the format of the registration certificate; and Annex 10, the declaration by the applicant of responsibility for the truthfulness of the information submitted. Annex 10 is the most easily overlooked and the most important — it places responsibility for the truthfulness of information squarely on the applicant, closing the loop with Article 15 of Law No. 216, under which the submission of false information can lead to revocation of the registration certificate.

Insight 4: there is also a Union-level coordination mechanism for resolving disagreements between member states.

The competent authority website also describes the functions of the Expert Community (Экспертное сообщество): a consultative body established under the Treaty on the Eurasian Economic Union of May 29, 2014 and the Agreement of December 23, 2014, responsible for handling disagreements between the reference state and the recognizing states over expert conclusions, determinations of whether a product is a medical device or should be classified as a measuring instrument, and classification disputes concerning the potential risk level. For projects on the Union track, this mechanism is the formal channel of resolution if member states disagree on classification or conclusions.

4. Practical recommendations

First, write the question of who holds the system account into the authorized representative agreement. The account is the submission channel, and control of that channel should be expressly agreed in the contract, including the account administrator, the handover mechanism and termination clauses. We have seen projects stall for months because a change of authorized representative left the account disconnected from the dossier.

Second, keep direct written communication records with the receiving department. The audit trail of the electronic system is valuable, but it does not replace communication. For issues such as classification doubts, sample requirements or inspection arrangements, we recommend seeking written confirmation from the receiving department and archiving it; the replies should be kept as annexes to the dossier.

Third, the Annex 10 declaration must be signed by a person with signing authority. This declaration is not a formality: it links responsibility for the truthfulness of information directly to revocation of the registration certificate. The signing entity, the signing authority and the chain of authorization should be consistent with the power of attorney.

Fourth, Union-track projects should prepare classification argumentation materials in advance. If the nature of the product (whether it is a device, or a measuring instrument) or its risk level is disputed, materials should be prepared within the scope of the Expert Community’s functions, so as to avoid repeated rework between the reference state and the recognizing states.

5. Verification checklist

• □ Confirm the receiving authority: the Department of Medicines and Medical Products of the Ministry of Health of the Kyrgyz Republic (ДЛСМИ), official website dlsmi.kg;
• □ Confirm the processing vehicle: the Information System of the Electronic Database of Medicines and Medical Products (ИС ЭБД ЛС и МИ);
• □ Download and verify the five forms currently published by the competent authority (Annexes 1, 2, 3, 4 and 10);
• □ Include clauses in the authorized representative agreement on the holding, management and handover of the system account;
• □ Confirm that the signatory of the Annex 10 declaration is consistent with the scope of the power of attorney;
• □ For Union-track projects: confirm that the nature and risk level of the product are undisputed, or that classification argumentation materials have been prepared.

Regulatory information verified as of October 29, 2026.

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

The GRZAN regulatory team consists of professionals with many years of hands-on experience in Eurasian Economic Union registrations. We maintain a stable local cooperation network in Bishkek, Almaty, Tashkent and Moscow, work in Chinese, Russian and English, and provide executable solutions for the issues foreign manufacturers most often encounter in CIS markets, including authorized representative arrangements, the notarization and legalization chain for powers of attorney, localization of technical documentation, and inspection readiness.

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

GRZAN provides registration support in Kyrgyzstan for medical device manufacturers, importers and authorized representatives. For project consultation on Kyrgyzstan or Eurasian Economic Union market access, contact us at info@grzanglobal.com.

GRZAN | Global Medical Device Regulatory Registration and Compliance Services