Kyrgyzstan Medical Device Registration Dossier Structure: Requirements and Practical Guide

1. Key takeaways

In Kyrgyzstan, the medical device registration dossier is compiled in accordance with Annex 1 of Cabinet of Ministers Resolution No. 513, and the entire cycle of registration, amendment, suspension and revocation is handled within the Information System of the Electronic Database of Medicines and Medical Devices (IS EBD LS i MI). When compiling the dossier, manufacturers should organize the evidence in three stages: technical testing under Decision No. 28, biological effect evaluation under Decision No. 38, and clinical and clinical laboratory trials under Decision No. 29, supplemented by the five official forms published by the competent authority. If the skeleton of the dossier is built incorrectly, every supporting document downstream will have to be reworked. This guide explains how to structure the dossier so that it passes acceptance review on the first attempt, and why the eleven legal definitions in Annex 1 serve as the most reliable table of contents for the entire submission package.

2. Legal basis

1. Resolution No. 513 of the Cabinet of Ministers, dated August 27, 2024, Annex 1, titled Procedures for State Registration, Assessment of Safety, Quality and Effectiveness, Maintenance of the National Register and Nomenclature, Amendments to the Registration Dossier, and Suspension or Revocation of the Registration Certificate:
   • Article 1 establishes the procedures for state registration, assessment of safety, effectiveness and quality, preparation of conclusions, issuance of registration certificates, amendments to the registration dossier, maintenance of the nomenclature and the national register, and suspension or revocation of registration certificates;
   • Article 2 defines verification, validation, medical device type, GMDN, applicant, model, nomenclature, accessory, production site, registration number and the authorized representative of the manufacturer;
   • Article 3 provides that registration is implemented by the subdivision of the authorized state body.
2. Article 2 of Resolution No. 513 references five technical rules to Eurasian Economic Commission Council and Board Decisions: Decision No. 173 on classification, Decision No. 27 on general safety and effectiveness requirements, Decision No. 38 on biological effect evaluation, Decision No. 28 on technical testing, and Decision No. 29 on clinical and clinical laboratory trials.
3. Five official forms published by the competent authority: Annex 1 (registration application form), Annex 2 (dossier amendment application form), Annex 3 (withdrawal application form), Annex 4 (registration certificate format) and Annex 10 (declaration of responsibility for the accuracy of submitted information).

3. Expert insights

Insight 1: The eleven definitions in Article 2 of Annex 1 are the table of contents of the dossier.

Reading the definitions one by one, one finds that they map almost exactly onto the eleven building blocks of a complete dossier. We recommend building the dossier table of contents directly on these eleven concepts so that no statutory element is omitted. The benefit is practical: reviewers work from the same conceptual framework, the structure of the submission matches their reading habits, and the probability of round-trip clarification requests drops significantly.

Insight 2: The three-stage evidence chain determines the depth of the dossier, not its page count.

Decision No. 28 on technical testing, Decision No. 38 on biological effect evaluation and Decision No. 29 on clinical and clinical laboratory trials each apply according to the risk class of the device. A Class 1 product may only need the first stage, while a Class 3 product must complete all three. We recommend building the dossier according to the evidence requirement matrix described in article 19 of this series, listing the evidence items required at each stage in one pass.

Insight 3: Electronic submission changes how the dossier is versioned.

Because the whole process runs in the IS EBD LS i MI system, the dossier effectively exists as a series of versions: every correction and every amendment creates a new timestamped record. There are three practical consequences. First, version numbers and dates must be consistent across all documents inside the dossier. Second, responses to deficiency letters should explicitly identify which document and which version they address. Third, once the certificate is issued, the dossier version on record becomes the baseline, and all subsequent amendments are measured against it.

Insight 4: The five published forms are the first gate of format compliance.

The competent authority publishes the application form, the amendment form, the withdrawal form, the certificate format and the declaration of responsibility. These forms must be used in their current versions. Continuing to submit an outdated form after an update is the most direct cause of format-based rejection at the acceptance stage. We recommend re-downloading all five forms about one week before filing and verifying them against the versions actually used in the dossier.

Insight 5: Internal consistency of the dossier matters more than the polish of any single document.

Article 09 of this series proposed a five-document cross-check. At the dossier level the scope is wider: the application form, the power of attorney, the free sale certificate, the quality system certificate, the technical documentation, the labeling and instructions for use, and the Annex 10 declaration must match word for word on the manufacturer name and address, model designations, specifications and production sites. No matter how well a single document is drafted, one inconsistency is enough to trigger a deficiency letter. Consistency checking is inexpensive; rework after acceptance is not.

4. Practical recommendations

First, build the table of contents on the eleven concepts of Article 2 of Annex 1. We recommend the following structure: overview and applicant information; authorized representative information; device type and nomenclature; model list; production sites; technical documentation; verification and validation; biological effect evaluation; clinical evidence; labeling and instructions for use; and the declaration of responsibility.

Second, assemble evidence according to the evidence requirement matrix. Determine first, based on the risk class, which stages of evidence apply, then collect documents stage by stage. This avoids both preparing material that will never be used and discovering late that one critical item is missing from the package.

Third, establish version management rules. Mark every document with a dossier version number, date and language; in deficiency responses, point explicitly to the document and version concerned; and after the certificate is issued, freeze the baseline version so that future amendments have a fixed reference point.

Fourth, re-download the five official forms one week before filing. Have the authorized representative perform the check and keep a dated record of the download, so that the versions submitted can always be traced to the versions published at the time of filing.

Fifth, complete a full consistency check across the seven document categories before submission. Check items: manufacturer name and address; models and specifications; production sites; intended use wording; shelf life and sterilization method; and software versions. Any mismatch, however small, should be corrected before the dossier enters the electronic system.

5. Verification checklist

• □ Dossier table of contents built on the eleven concepts of Article 2 of Annex 1 to Resolution No. 513;
• □ Evidence stages determined according to risk class under Decisions No. 28, No. 38 and No. 29;
• □ Version numbers and dates consistent across the dossier, with deficiency responses pointing to specific documents and versions;
• □ The five published forms (Annexes 1, 2, 3, 4 and 10) re-downloaded and confirmed to be current versions;
• □ Full consistency check completed across the seven document categories (application form, power of attorney, free sale certificate, quality system certificate, technical documentation, labeling and instructions for use, declaration of responsibility);
• □ Confirmed that the process carrier is the IS EBD LS i MI system and that the account is held by the authorized representative.

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, manufacturing site inspection coordination, quality management system compliance support, post-market surveillance and device vigilance system setup, import and distribution compliance, and fee calculation and project budget management.

The GRZAN regulatory team consists of professionals with many years of hands-on experience in Eurasian Economic Union registration. We maintain a stable local cooperation network in Bishkek, Almaty, Tashkent and Moscow, work in Chinese, Russian and English, and provide executable solutions for foreign manufacturers on the issues most commonly encountered in CIS markets: authorized representative arrangements, notarization and legalization chains for powers of attorney, technical documentation localization, and inspection readiness. GRZAN supports manufacturers, importers and authorized representatives throughout the Kyrgyzstan registration lifecycle.

We adhere to one principle: every regulatory conclusion we publish must rest on verifiable official sources. Any figure or timeframe that cannot be verified is labeled as a practical estimate and is never presented as a legal requirement.

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

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