Kyrgyzstan Medical Device Risk Classification: The EEC Decision No. 173 Rules

1. Key takeaways

Kyrgyzstan has no classification rules of its own for medical devices. Paragraph 1 of Article 2 of Cabinet Resolution No. 513 expressly provides that the classification of medical devices by potential risk of use follows the Rules for the Classification of Medical Devices by Potential Risk of Use approved by Decision No. 173 of the Executive Committee of the Eurasian Economic Commission dated December 22, 2015. The classes are 1, 2a, 2b and 3. The practical meaning of this arrangement is that even on the national track, risk is measured with the Union ruler: the classification outcome determines the scope of testing, the inspection requirements and the tier of official fees.

2. Legal basis

1. Cabinet Resolution No. 513 of August 27, 2024, paragraph 1 of Article 2: classification follows Decision No. 173 of the Executive Committee of the Eurasian Economic Commission of December 22, 2015.
2. Paragraph 2 of Article 2 of Cabinet Resolution No. 513: safety and effectiveness requirements follow Council Decision No. 27 of the Eurasian Economic Commission of February 12, 2016, with the exception of item 63.
3. Paragraph 3 of Article 2 of Cabinet Resolution No. 513: biological effects evaluation studies follow Council Decision No. 38 of May 16, 2016.
4. Paragraph 4 of Article 2 of Cabinet Resolution No. 513: technical testing follows Council Decision No. 28 of February 12, 2016.
5. Paragraph 5 of Article 2 of Cabinet Resolution No. 513: clinical and clinical laboratory trials follow Council Decision No. 29 of February 12, 2016.
6. Article 14 of Law No. 216: registration requires a positive expert evaluation of safety, quality and effectiveness, taking into account the potential risk level of use of the device.

3. Expert insights

Insight 1: a national procedure combined with Union technical rules is the structural feature of this market.

Article 2 of Resolution No. 513 transfers five Union decisions in one breath, covering classification, general requirements, biological effects, technical testing and clinical trials. This is not legislative inertia but deliberate design: the procedure stays domestic to preserve control, while the technical requirements are aligned with the Union to preserve portability. The most direct consequence for companies is that most of the technical evidence prepared under the national track can be reused when the dossier migrates to the Union track after 2028. This is precisely why taking the national track now remains a rational choice during the transition period.

Insight 2: Decision No. 27 is applied with the exception of item 63, and this carve-out deserves a separate flag.

Paragraph 2 of Article 2, when transferring the general safety and effectiveness requirements, expressly excludes item 63. A carve-out inside a transfer provision is usually the legislator’s signal that one specific requirement is reserved on its local applicability. When building the conformity evidence table, verify Decision No. 27 item by item and flag item 63 separately as not applicable — this avoids being asked during review for evidence that is not needed, and also avoids evidence gaps caused by overlooking the exclusion.

Insight 3: the classification outcome is the common upstream of three cost lines.

The risk class is not a one-off label; it is the starting point of three branches:

• Scope of testing: the class determines the necessity of technical testing, biological effects evaluation and clinical trials;
• Inspection requirements: devices in class 2a (sterile), 2b and 3 trigger production site inspections;
• Official fee tiers: state procedure fees are set in four tiers for classes 1, 2a, 2b and 3 (amounts should be confirmed against the payment notice issued by the competent authority; see Article 34 of this series).

If the classification is wrong, all three branches must be redone. Classification is the highest-return judgment in the entire project; it should be done first, and it should be done as a written argumentation.

Insight 4: classification disputes have a formal resolution channel.

As introduced in Article 02 of this series, one of the functions of the Expert Community is to handle disputes over classification by potential risk level and by type and to refer matters on which no consensus is reached to the consultative committee at the Union level. If a company and the receiving department disagree on classification, this mechanism can be used rather than passively accepting the outcome.

4. Practical recommendations

First, turn the classification argumentation into a reusable standalone document. We recommend preparing a classification justification sheet for every product: compare the criteria of Decision No. 173 one by one (intended purpose, duration of use, invasiveness, mode of contact with the body, whether vital organs are affected) and state the conclusion and its basis. This document is repeatedly used in three stages: testing plan design, inspection application, and change assessment.

Second, for borderline products, seek confirmation before submission. The classification of combination products, drug-device combinations, products with both diagnostic and therapeutic functions, and software products often leaves room for interpretation. We recommend seeking written confirmation from the receiving department before submission and archiving the reply.

Third, build the evidence table item by item against Decision No. 27, and mark item 63 as not applicable. Do not map entries directly from domestic habits or from Annex I of the EU MDR — different entry systems produce confusion in cross-referencing.

Fourth, build a change trigger mechanism around the classification outcome. Any change in intended purpose, duration of use or invasiveness may change the risk class. The change management procedure should include a preliminary check on whether a change affects the classification (see Article 35 of this series).

5. Verification checklist

• □ Obtain the current text of Executive Committee Decision No. 173 of the Eurasian Economic Commission (December 22, 2015) and compare the criteria item by item;
• □ Prepare a written classification justification for every product to be registered, stating the class among 1 / 2a / 2b / 3;
• □ Confirm that the classification outcome is consistent with the testing plan, the inspection application and the official fee tier;
• □ Build the conformity evidence table against the entries of Decision No. 27 (February 12, 2016), with item 63 separately marked as not applicable;
• □ For borderline products, written confirmation has been obtained from the receiving department and archived;
• □ The change management procedure includes a preliminary check on whether a change affects the risk class.

Regulatory information verified as of October 29, 2026.

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