Kyrgyzstan Medical Device Registration: Clinical and Biological Evaluation Evidence Requirements

1. Key takeaways

On the two technical dimensions of clinical and biocompatibility evidence, Kyrgyzstan likewise does not build its own rules but transfers them by reference to union decisions: clinical and clinical laboratory trials follow Eurasian Economic Commission Council Decision No. 29 of February 12, 2016; studies (trials) for the evaluation of biological effects follow Eurasian Economic Commission Council Decision No. 38 of May 16, 2016. Together with technical testing (Decision No. 28), the three instruments form the complete skeleton of the evidence section of the registration dossier. These three transfers mean that even the national route requires evidence prepared to union standards.

2. Legal basis

1. Cabinet Resolution No. 513, August 27, 2024, Article 2 item 3: studies for the evaluation of biological effects follow Eurasian Economic Commission Council Decision No. 38 of May 16, 2016, Rules for Conducting Studies (Trials) to Evaluate the Biological Effects of Medical Devices.
2. Article 2 item 4 of Cabinet Resolution No. 513: technical testing follows Eurasian Economic Commission Council Decision No. 28 of February 12, 2016, Rules for Conducting Technical Tests of Medical Devices.
3. Article 2 item 5 of Cabinet Resolution No. 513: clinical and clinical laboratory trials follow Eurasian Economic Commission Council Decision No. 29 of February 12, 2016, Rules for Conducting Clinical and Clinical Laboratory Trials (Studies) of Medical Devices.
4. Article 14 of Law No. 216: registration requires a favorable expert opinion on safety, quality and efficacy, corresponding to the potential use risk class.
5. Article 2 of Annex 1 to Cabinet Resolution No. 513: defines the concepts of verification and validation.

3. Expert insights

Insight one: the three transferred decisions form a three-tier evidence ladder tied to risk class.

Decision No. 28 (technical testing), Decision No. 38 (biological effects evaluation) and Decision No. 29 (clinical and clinical laboratory trials) correspond to three layers of device evidence: does it work as intended, is contact with the human body safe, and is clinical use effective. The higher the risk class, the more layers must be completed. We recommend drawing an evidence requirements matrix by risk class, listing in one pass which trials each class requires, rather than discovering requirements by trial and error.

Insight two: clinical and clinical laboratory are two distinct concepts for two distinct device families.

The title of Decision No. 29 contains both clinical and clinical laboratory trials. The distinction matters most for in vitro diagnostics: clinical laboratory trials are the main performance verification route for IVDs, covering analytical and clinical performance, while clinical trials serve mainly therapeutic and interventional devices. IVD manufacturers should state explicitly which track their evidence plan follows and build protocols and reports to the corresponding requirements (see article 28).

Insight three: the definitions of verification and validation written into the procedure signal that methodology will be scrutinized.

Article 2 of Annex 1 to Cabinet Resolution No. 513 defines validation (confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application are fulfilled) and verification (confirmation, through the provision of objective evidence, that specified requirements have been fulfilled). Writing these two concepts into the procedure means reviewers will examine not only conclusions but also whether the methodology is sound. Test reports should demonstrate the methodological basis, the logic behind sample size determination, and the criteria for judging results.

Insight four: what the eight-jurisdiction simplified channel waives is precisely this workload.

As discussed in article 13, the simplified channel allows omission of the conformity standards list, efficacy and safety test protocols, clinical trial reports, storage stability test reports, and documents on medicinal products, sterilization and software. Measured against the three-tier evidence ladder, the simplified channel waives the main documents of the second and third tiers (biological effects and clinical) while leaving room for judgment on the first tier (technical testing). This also explains how the simplified channel achieves roughly a 40 percent timeline reduction.

Insight five: domestic evidence capacity is limited, so external test reports are the norm.

The multilateral country study noted that Kyrgyzstan has no institutionalized clinical trial infrastructure and that the national registration system accepts third-party protocols and reports. The implication: trials completed in China or third countries have a realistic basis for acceptance, provided they satisfy the union decisions. We recommend designing trial protocols against Decisions No. 28, 29 and 38 at the study-design stage, not retrofitting them afterwards.

4. Practical recommendations

First, draw an evidence requirements matrix by risk class. Build one matrix per product line: rows for risk classes 1, 2a, 2b and 3; columns for technical testing, biological effects evaluation, and clinical and clinical laboratory trials; each cell filled with the applicable requirement and standard. The table is reusable for all subsequent products.

Second, protocol before trial. Given limited domestic evidence capacity and the norm of external reports, draft the protocol against Decisions No. 28, 29 and 38 before conducting trials in China or third countries, and have the authorized representative or a local adviser pre-review it. Retrofitting a protocol afterwards often means repeating the trial.

Third, make the methodology visible in test reports. State the methodological basis, the logic behind sample size determination, the result acceptance criteria and the statistical handling, aligned with the definitions of verification and validation.

Fourth, IVD products should explicitly take the clinical laboratory trial track. Mark the trial category in the evidence plan and prepare the evidence in two parts, analytical performance and clinical performance (see article 28).

5. Verification checklist

• □ Current texts of the three decisions obtained: No. 28 (2016-02-12), No. 29 (2016-02-12), No. 38 (2016-05-16);
• □ An evidence requirements matrix by risk class has been drawn, defining the trial layers required for each class;
• □ Trial protocols have been drafted against the three decisions and pre-reviewed by the authorized representative or a local adviser;
• □ Test reports demonstrate the methodological basis, sample size logic, acceptance criteria and statistical handling;
• □ IVD products explicitly follow the clinical laboratory trial track, with evidence prepared separately for analytical and clinical performance;
• □ The availability of the simplified channel has been assessed: for holders of eight-jurisdiction certificates, confirm the scope of waivable documents (see article 13).

Regulatory information verified as of October 29, 2026.

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