Kyrgyzstan Medical Device Technical Testing: Decision No. 28 Requirements and Practical Guide

1. Key takeaways

For technical testing, Kyrgyzstan explicitly references Decision No. 28 of the Council of the Eurasian Economic Commission, dated February 12, 2016, on the Rules for Conducting Technical Tests of Medical Devices, on the basis of paragraph 4 of Article 2 of Cabinet of Ministers Resolution No. 513. Technical testing is the first stage of the three-stage evidence chain, answering the question of whether the device performs as intended. It is also the one stage that is not fully waived under the simplified pathway for holders of approvals from eight reference jurisdictions: even where a manufacturer holds approvals from the European Union, the United States, Japan and comparable authorities, some evidentiary judgment on technical performance is retained. Planning the testing program early therefore pays off on every pathway.

2. Legal basis

1. Resolution No. 513 of the Cabinet of Ministers, dated August 27, 2024, paragraph 4 of Article 2: technical tests are conducted in accordance with Decision No. 28 of the Council of the Eurasian Economic Commission dated February 12, 2016, on the Rules for Conducting Technical Tests of Medical Devices.
2. Resolution No. 513, paragraph 3 of Article 2: studies for the evaluation of biological effects follow Council Decision No. 38 dated May 16, 2016.
3. Resolution No. 513, paragraph 5 of Article 2: clinical and clinical laboratory trials follow Council Decision No. 29 dated February 12, 2016.
4. Annex 1 to Resolution No. 513, Article 2: defines verification (confirming that specified requirements have been fulfilled) and validation (confirming that requirements for a specific intended use or application have been met).
5. Multilateral country survey report (Japan International Cooperation Agency, November 2025): registration under Union rules requires delivery of physical equipment to testing institutions in Russia or Kazakhstan, with transportation costs borne by the applicant.

3. Expert insights

Insight 1: Technical testing is the foundation of the three-stage evidence chain and the only stage not fully waived under the simplified pathway.

Article 13 of this series explains that the simplified pathway can waive the list of conformity standards, efficacy and safety test protocols, clinical trial reports, storage stability test reports, and documents concerning medicinal substances, sterilization and software. Comparing the three decisions shows that the waivers concern mainly the biological effect (Decision No. 38) and clinical (Decision No. 29) stages, while the evidentiary judgment under technical testing (Decision No. 28) remains. The structural lesson is clear: even on the simplified pathway, technical performance evidence should be prepared thoroughly, because it is the layer the reviewer will still examine.

Insight 2: The concepts of verification and validation determine the structure of the technical test report.

Article 2 of Annex 1 defines the two terms separately. Applied to technical testing, the division of labor is: verification answers whether the product meets specified technical requirements, such as dimensions, performance parameters and electrical safety; validation answers whether the product meets the requirements of use under the intended conditions of use, such as performance in simulated use scenarios. We recommend organizing the technical test report in these two parts so that it meshes with the statutory definitions. A report structured this way lets the reviewer map the evidence onto the legal vocabulary without translation effort.

Insight 3: Physical sample delivery is a real constraint on the Union track, with comparatively less pressure on the national track.

The multilateral country survey records that registration under Union rules requires delivery of physical equipment to testing institutions in Russia or Kazakhstan, with transportation costs borne by the applicant. For large equipment, this is a substantial direct and time cost. For national-track projects, we recommend confirming the testing location and sample requirements with the authorized representative at the test-plan drafting stage, so that the plan is never finalized only to discover that the samples cannot be delivered as required. Freight, customs and lead time all belong in the project plan from day one.

Insight 4: Reviewing the test plan before testing is the key to cost control.

Given sample transportation and testing fees, retrofitting a plan after the fact is extremely expensive. We recommend completing the test plan against the requirements of Decision No. 28 before any testing begins, and having it pre-reviewed by the authorized representative or a local advisor (see article 19 of this series). This matters most for active devices and large equipment, where a single failed or unrepeatable test can force shipment of a second unit across borders.

Insight 5: Technical testing and the conformity evidence table support each other.

Where the method-of-conformity column of the conformity evidence table (article 24 of this series) cites technical testing, it should point to the test report. Cross-referencing the two documents allows the reviewer to build the requirement-to-evidence mapping immediately and reduces clarification round-trips. Conversely, the report should identify the items of Decision No. 27 that each test supports, closing the loop in both directions.

4. Practical recommendations

First, organize the technical test report in two parts: verification and validation. Make the split explicit in the report table of contents: the verification part covers conformity with specified technical requirements; the validation part covers performance under the intended conditions of use.

Second, the test plan precedes sample shipment. Complete and pre-review the plan before dispatching samples. For large equipment, confirm in advance the testing institution, the mode of transport and the customs clearance arrangements for both directions.

Third, prepare a purpose statement for sample import. Importing samples for registration and assessment purposes is a permitted scenario under Article 30 of Law No. 216. Prepare in advance a statement of sample names and models, quantities, purpose, testing institution and post-test disposition (see article 37 of this series).

Fourth, cross-index the technical test report and the conformity evidence table. Record the report number and section in the evidence table, and identify the items of Decision No. 27 supported by each test in the report itself.

5. Verification checklist

• □ Current text of Decision No. 28 of the Council of the Eurasian Economic Commission (February 12, 2016) obtained;
• □ Technical test report organized in verification and validation parts;
• □ Test plan completed and pre-reviewed before sample shipment;
• □ Purpose statement for sample import prepared (names and models, quantities, purpose, testing institution, disposition);
• □ Technical test report and conformity evidence table cross-indexed;
• □ For large equipment projects, testing institution, transport mode and customs arrangements confirmed in advance.

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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