Kyrgyzstan Post-Market Monitoring for Medical Devices: Parallel Obligations Under Cabinet Resolution No. 513

1. Key takeaways

Post-market surveillance in Kyrgyzstan is not an ancillary clause attached to the registration procedure, but an independent procedure that runs in parallel with registration: Cabinet Resolution No. 513 provides for it through two separate annexes — Annex 1 establishes the state registration and appraisal procedure, while Annex 2 establishes the Procedure for Monitoring the Safety, Quality and Effectiveness of Medical Devices. The structural signal is unambiguous: obtaining the certificate and keeping the certificate are two parallel sets of obligations.

2. Legal basis

1. Cabinet Resolution No. 513, August 27, 2024:
   • Article 1(2): approves Annex 2, the Procedure for Monitoring the Safety, Quality and Effectiveness of Medical Devices;
   • Article 1(1): approves Annex 1, the procedure for state registration, appraisal of safety, quality and effectiveness, maintenance of the national register and nomenclature, changes to registration files, and suspension or revocation of registration certificates;
   • Article 3(2): repeals Government Decree No. 359 of August 1, 2018, on approving the procedure for monitoring the quality, safety and effectiveness of medical devices;
   • Article 4: the resolution enters into force 10 days after its official publication.
2. Article 14 of Law No. 216: the obligation to report changes in device data and information rests with the manufacturer or its authorized representative.
3. Article 15 of Law No. 216: grounds for suspension and revocation of registration certificates, including the emergence of new systematic data indicating that risks outweigh benefits.
4. Cabinet Resolution No. 450, June 29, 2026: procedures for inspections in the distribution stage.

Source note: the article-by-article content of Annex 2 (surveillance content, reporting format, reporting cycle and reporting channels) was not available this round in official wording suitable for verbatim citation. The following is therefore framed at the level of procedural structure and principles; specific compliance requirements must be checked against the original text of Annex 2 to Cabinet Resolution No. 513.

3. Expert insights

Insight one: by using a structure of two annexes, the resolution places the pre-market and post-market stages at the same level.

This is not a matter of formatting habit but of legislative design. Annex 1 governs market entry, and Annex 2 governs staying on the market; both are established by the same cabinet resolution and take effect at the same time. When companies build their compliance systems, they should likewise build them at these two levels: a registration dossier system corresponding to Annex 1, and a surveillance system corresponding to Annex 2. The same teams may maintain both systems, but the two must not be conflated.

Insight two: the new procedure replaced the 2018 procedure, and experience under the old rules no longer applies.

Article 3(2) of Cabinet Resolution No. 513 expressly repeals Government Decree No. 359 of August 1, 2018. This means that surveillance workflows, forms and reporting conventions established before Resolution No. 513 entered into force must be re-checked. For companies that have been selling in Kyrgyzstan for many years, this point is especially important: continuing to follow the old workflows will cause the manner of performance to diverge from current requirements.

Insight three: the surveillance obligation is directly tied to the survival of the registration certificate.

Article 15 of Law No. 216 lists the emergence of new systematic data indicating that risks outweigh benefits as a ground for revocation of a registration certificate. Where does new systematic data come from? Primarily from post-market surveillance. This creates a closed loop: systematic risk signals identified through surveillance can, in turn, become the basis for revoking the certificate. Surveillance is therefore not about handing documents to the regulator; it is about taking responsibility for your own registration certificate.

Insight four: the reporting obligation falls on the manufacturer or its authorized representative, which requires a clear internal division of labor.

Article 14 places the obligation on both. We recommend clarifying the division of labor within the company and in agreements: the authorized representative is responsible for receipt, translation and submission; the manufacturer is responsible for technical assessment and content. Without an agreed division of labor, responsibility for missed reports is difficult to allocate, and the competent authority will look only at what is recorded on the registration certificate.

Insight five: surveillance and inspections are designed to work together.

Cabinet Resolution No. 450 extends inspections into the distribution stage. Inspectors will request surveillance records — including complaint handling records, adverse event reports and vigilance files. We recommend organizing surveillance records as part of a standing inspection readiness package (see article 16) and keeping them reviewable at any time.

4. Practical recommendations

First, build two systems corresponding to the two annexes. We recommend maintaining two sets of documentation: a registration dossier system corresponding to Annex 1 and a post-market surveillance system corresponding to Annex 2, each with an assigned owner and a defined update frequency.

Second, audit and update legacy workflows. If your company previously established surveillance workflows under Decree No. 359 of 2018, we recommend re-checking forms, reporting conventions and submission channels against Annex 2 to Cabinet Resolution No. 513, and retaining records of the update.

Third, allocate surveillance duties in agreements. We recommend stipulating that the authorized representative is responsible for receipt, translation and submission; the manufacturer is responsible for technical assessment and content; and that the parties agree on response deadlines.

Fourth, establish an internal review mechanism for surveillance data. We recommend reviewing surveillance data on a regular basis — at least quarterly — to assess whether any systematic signal has emerged. This review is both a compliance action and a self-check on registration certificate risk.

Fifth, include surveillance records in the inspection readiness package. We recommend including complaint handling records, adverse event reports, vigilance files and periodic review records, all kept up to date.

5. Verification checklist

• □ Systems have been established for the two annexes of Cabinet Resolution No. 513 respectively: a registration dossier system (Annex 1) and a surveillance system (Annex 2);
• □ Legacy workflows established under Decree No. 359 of 2018 have been audited and updated, with update records retained;
• □ Agreements specify the internal division of surveillance duties: the authorized representative handles receipt, translation and submission; the manufacturer handles technical assessment;
• □ A quarterly review mechanism for surveillance data is in place to assess whether systematic risk signals have emerged;
• □ Surveillance records (complaints, adverse events, vigilance files, review records) are included in the standing inspection readiness package;
• □ The original text of Annex 2 to Cabinet Resolution No. 513 has been obtained to verify specific compliance requirements.

Regulatory information verified as of October 29, 2026.

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