Kyrgyzstan Medical Device Inspections and Liability: Cabinet Resolution No. 450 and Inspection Readiness

1. Key takeaways

In 2026, inspections in Kyrgyzstan were redefined as an independent procedure: Cabinet Resolution No. 450 (June 29, 2026) approved the Procedure for Inspections in the Field of Medical Device Circulation, adopted under Article 18(3), paragraph 2 of Law No. 216, and simultaneously repealed item 1 of Government Decree No. 120 of March 15, 2019. Inspections cover both the manufacturing and distribution stages; they can be triggered during registration or launched separately in the distribution stage. For foreign manufacturers, the direct counterpart in an inspection is the authorized representative, not the manufacturer itself.

2. Legal basis

1. Law of the Kyrgyz Republic on the Circulation of Medical Devices, Law No. 216 of December 29, 2023, Article 18(3), paragraph 2: the statutory authorization for the cabinet to establish inspection procedures.
2. Cabinet Resolution No. 450, June 29, 2026, on approving the Procedure for Inspections in the Field of Medical Device Circulation:
   • item 1: approves the inspection procedure;
   • item 2: instructs the Ministry of Health to take the corresponding implementing measures within two months;
   • item 3: implementation is to take place within the annual budget allocated by the Ministry of Health;
   • item 4: repeals item 1 of Government Decree No. 120 of March 15, 2019;
   • item 5: enters into force 10 days after its official publication.
3. Cabinet Resolution No. 513, August 27, 2024, Annex 1 (the manufacturing inspection stage within the registration procedure).
4. Explanatory note to the Ministry of Health draft amendments of 2026: inspections apply to class 2a (sterile), 2b and 3 devices, the inspection period does not exceed 90 calendar days and is not counted toward the total registration time (draft status).
5. Article 2 of Annex 1 to Cabinet Resolution No. 513: the authorized representative bears responsibility for the placing on the market of devices and for compliance with mandatory requirements.

Source note: the article-by-article content of the inspection procedure annexed to Resolution No. 450, as well as inspection frequency, the method of drawing up inspection plans and the handling of results, were not available this round in official wording suitable for verbatim citation. The following is framed at the level of the verified procedural framework.

3. Expert insights

Insight one: the source of the inspection power means it does not depend on registration.

Resolution No. 450 rests on Article 18 of Law No. 216, not on the registration provisions. This means that inspection is a product of distribution oversight powers and can be launched on its own, without any pending registration application. Companies should adjust their preparation accordingly: from preparing for a single registration event to maintaining a standing state of inspection readiness.

Insight two: two stages, one set of materials.

Inspections cover the manufacturing stage and the distribution stage:

• Manufacturing stage: production conditions, the quality management system, batch records, traceability records, outsourced sites;
• Distribution stage: consistency between the product and the registration dossier, labeling, operator qualifications, and fulfillment of surveillance and vigilance obligations.

The overlap between the two is substantial — batch records, traceability records and complaint and vigilance files will be requested in both stages. This is why article 16 of this series recommends building a standing inspection readiness package once and reusing it across both scenarios.

Insight three: the inspection counterpart is the authorized representative, a natural extension of the resident entity requirement.

Article 2 of Annex 1 to Cabinet Resolution No. 513 provides that the authorized representative bears responsibility for the placing on the market of devices and for compliance with mandatory requirements imposed on them. An inspection is a verification of compliance with those mandatory requirements, and its natural counterpart is the party bearing that responsibility. The manufacturer’s role is to provide technical documentation and remote support.

Insight four: the inspection period is excluded from the registration timeline, a key scheduling constraint.

The explanatory note to the ministry’s draft states expressly that the inspection period is not counted toward the total registration time and does not exceed 90 calendar days. Added to the standard procedure of at most 50 calendar days (counted from confirmation of fee payment), the upper bound for projects requiring an inspection approaches 140 calendar days, excluding periods for deficiency correction and payment. Waiting for an inspection is not part of waiting for approval; it is an additional stretch of time.

Insight five: implementing measures are still on the way, so tracking is necessary.

Item 2 of Resolution No. 450 instructs the Ministry of Health to take implementing measures within two months. This means the operational details of inspections (inspection plans, appointment of inspectors, report formats, handling of results) will be issued progressively in departmental documents. We recommend continuous tracking by the authorized representative, with the inspection readiness package updated after each implementing document is published.

4. Practical recommendations

First, make inspection preparation a standing practice, not a project action. We recommend building a standing inspection readiness package, updated quarterly by the authorized representative, containing: quality system certificates and the most recent audit report, site lists and quality agreements, batch record samples, traceability records, complaint and vigilance files, surveillance records, label samples, and the list of distributor licenses.

Second, write the inspection interface process into the authorized representative agreement. We recommend specifying: the deadline for notifying the manufacturer after an inspection notice is received, the manufacturer’s support obligations, the division of on-site cooperation, responsibility for providing documents, and the allocation of responsibility for reporting results and implementing corrective actions.

Third, schedule projects requiring inspections on a worst-case basis. We recommend planning on the basis of 50 calendar days plus 90 calendar days plus a buffer for deficiency correction and payment, and aligning internal expectations accordingly.

Fourth, track the ministry’s implementing documents. We recommend specifying in the representative’s duties the tracking of publications under Resolution No. 450, and completing the update of the inspection readiness package within one month of each document’s publication.

Fifth, retire the old experience from the 2019 Decree No. 120 era. Item 4 of the resolution expressly repeals item 1 of Decree No. 120. We recommend cleaning internal documents of references to the old decree to avoid preparing under outdated assumptions.

5. Verification checklist

• □ The original text of Cabinet Resolution No. 450 (June 29, 2026) and its annexed inspection procedure has been obtained;
• □ A standing inspection readiness package covering both the manufacturing and distribution stages has been built and is updated quarterly by the authorized representative;
• □ The authorized representative agreement includes the inspection interface process: notification deadlines, support obligations, on-site division of labor, document responsibility, corrective action allocation;
• □ Projects requiring inspections are scheduled on the basis of 50 plus 90 calendar days plus a buffer;
• □ A tracking mechanism for implementing documents is in place, with the readiness package updated within one month of publication;
• □ Internal documents referencing Government Decree No. 120 of March 15, 2019 have been cleaned up.

Regulatory information verified as of October 29, 2026.

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