Kyrgyzstan Prohibited Medical Device Imports: Article 31 Restrictions and Shelf-Life Rules

1. Key takeaways

Article 31 of Law No. 216 lists the circumstances in which import is prohibited, which fall into four groups. First, unregistered devices intended for humanitarian purposes that are also not registered in the manufacturing country or the donor country are prohibited from import. Second, non-conforming devices. Third, counterfeit devices. Fourth, used devices, absent a manufacturer’s certificate of repair and usability, and devices with less than one third of their total shelf life remaining, except devices without a shelf life. The one-third remaining shelf life rule is a hard arithmetic constraint that ties production dates directly to logistics cycles.

2. Legal basis

1. Law of the Kyrgyz Republic on the Circulation of Medical Devices, Law No. 216 of December 29, 2023, Article 31: medical devices prohibited from import.
2. Law No. 216, Article 29: devices registered and entered in the national register are imported on the strength of the register entry; unlisted devices require an import permit conclusion.
3. Law No. 216, Article 30: entities that may import for registration and expert review purposes.
4. Law No. 216, Article 16: circumstances exempt from registration.

Source note: the verbatim text of the individual paragraphs of Article 31 was not available this cycle in an official text capable of citation. The provisions are therefore stated here by category; concrete application is governed by the current statutory text.

3. Expert insights

Insight 1: the first prohibition targets humanitarian aid devices that are stranded between two systems.

The rule is that an unregistered device intended for humanitarian purposes is prohibited from import if it is also unregistered in the manufacturing country or the donor country. The reach of this rule is narrow but precise. It admits humanitarian aid devices that are registered in a country with a functioning system and merely lack Kyrgyz registration for procedural reasons, while blocking products that have no registration status anywhere from entering under a humanitarian label. For companies, even through donation or aid channels, the registration status of the product in its country of origin remains the precondition.

Insight 2: for used devices in the fourth group, the rule is that a certificate is sufficient.

Used devices are not banned outright; the ban applies to those without a manufacturer’s certificate of repair and usability. This leaves a channel for handling second-hand equipment, demonstration units, and post-exhibition equipment: with a certificate of repair and usability issued by the manufacturer, import is permitted. We recommend obtaining this document from the manufacturer in advance when disposing of demonstration units and exhibits.

Insight 3: the one-third remaining shelf life rule binds the supply chain to the regulation.

For products with a shelf life, such as sterile consumables, in vitro diagnostic reagents, and drug-device combinations, the remaining shelf life at import must not fall below one third of the total. The rule carries three practical implications:

• The longer the shelf life, the larger the workable window: a product with a 3-year shelf life can be imported with 1 year remaining, while a product with a 6-month shelf life is at the margin with only 2 months left;
• Short shelf-life products do not fit long logistics chains: Central Asia routes combining sea and land transport take considerable time, and short shelf-life products may fail the requirement on arrival;
• The labeling format can amplify or mitigate the problem: we recommend marking both the production date and the expiry date (see Part 30 of this series).

Insight 4: the exception for devices without a shelf life covers most durable equipment.

The rule states expressly that devices without a shelf life are not subject to the remaining shelf life restriction. Large durable equipment such as MRI, CT, and ultrasound systems therefore falls outside this provision, while reagents, consumables, and sterile products are the main affected categories. We recommend setting supply chain rules by product category rather than applying one standard across the board.

Insight 5: the non-conforming and counterfeit categories depend directly on quality systems and traceability.

The determination of non-conforming and counterfeit devices relies on test results and product traceability. We recommend keeping complete batch records, inspection records, and traceability chains, so that a challenged shipment can be substantiated quickly. This is also why, in Part 16 of this series, we recommend placing batch and traceability records in the inspection readiness kit.

4. Practical recommendations

First, set supply chain shelf-life rules by product category. We recommend an internal standard for remaining shelf life at shipment that is stricter than the statutory one-third floor, leaving buffer for customs delays.

Second, switch short shelf-life products to faster logistics modes. For products with a shelf life under one year, we recommend evaluating air or rail options so that the remaining shelf life on arrival is not insufficient.

Third, obtain the manufacturer’s certificate for used and demonstration equipment in advance. We recommend adding the step of obtaining the manufacturer’s certificate of repair and usability into the disposal workflows for demonstration units, exhibits, and returned units.

Fourth, aid and donation products still require registration status in the country of origin. We recommend verifying the registration status of the product in the manufacturing country before launching a donation program (see Part 06 of this series).

Fifth, keep complete batch records and traceability chains. We recommend retaining production batch numbers, inspection reports, and traceability records for every shipment, enabling rapid self-substantiation when challenged.

5. Verification checklist

• □ Supply chain shelf-life rules set by category, with internal standards stricter than the statutory remaining one-third requirement;
• □ Faster logistics modes have been evaluated for short shelf-life products, defined as those with a shelf life under one year;
• □ Second-hand equipment, demonstration units, and exhibits are covered by a manufacturer’s certificate of repair and usability;
• □ Aid and donation programs have verified the registration status of the products in the country of origin;
• □ Durable equipment without a shelf life has been confirmed as outside the remaining shelf life restriction;
• □ Every shipment retains production batch numbers, inspection reports, and traceability records enabling rapid self-substantiation.

Regulatory information verified as of October 29, 2026.

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GRZAN provides registration and compliance support in Kyrgyzstan for medical device manufacturers, importers, and authorized representatives. For project consultation on market access in Kyrgyzstan or the Eurasian Economic Union, please contact us at info@grzanglobal.com.

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