Kyrgyzstan Medical Device Import and Customs Clearance: National Register and Import Permit Conclusions

1. Key takeaways

Kyrgyzstan law provides two import channels for devices. First, devices that are registered and entered in the national register may be imported on the strength of the register entry. Second, devices not entered in the register require an import permit conclusion issued by the regulatory body, with the detailed procedure set by the Cabinet. Law No. 216 also lists the specific situations in which the permit conclusion route may be used, including standard samples, unregistered devices imported for registration, devices imported for emergency treatment of a specific patient, a batch of devices imported for clinical research, devices imported for the introduction of innovative technology or for scientific research, exhibits without sales rights, and devices under government programs or humanitarian aid.

2. Legal basis

1. Law No. 216, Article 29: medical devices that are registered and entered in the national register are imported on the strength of the register entry; devices not entered in the register require an import permit conclusion issued by the regulatory body, with the procedure set by the Cabinet.
2. Law No. 216, Article 30: the holder of a foreign registration certificate, the authorized representative office of the manufacturer, or a commissioned agent may import devices for registration and expert review purposes.
3. Law No. 216, Article 31: circumstances prohibiting import (see Part 38 of this series for detail).
4. Law No. 216, Article 16: circumstances exempt from registration, including device samples used for national registration and standard samples.
5. Cabinet Resolution No. 513, August 27, 2024, Annex 1, Article 2: definition of the registration number, the identifier assigned to a device at registration, under which it is entered in the national register of registered devices.
6. Multilateral country research report (Japan International Cooperation Agency, November 2025): all devices in use in Kyrgyzstan, including peripherals and consumables, must be registered; customs releases only registered items, and documents proving registration must be submitted to customs at import.

3. Expert insights

Insight 1: the certificate and the national register are two separate steps, and import looks at the latter.

Article 29 speaks of devices that are registered and entered in the national register. This means one more step follows the certificate: the data must be entered into the national register and generate a saleable and importable register entry. In Part 23 of this series we recommend checking five register items after the certificate is issued, the device name, the type and model list, the registration number, the holder, and the authorized representative. The reason is exactly here: if the model scope in the register is narrower than on the certificate, import will still be blocked.

Insight 2: the permit conclusion is a second import channel outside registration, covering seven situations.

Article 29 empowers the Cabinet to set the procedure for the permit conclusion, and the law itself lists the situations eligible for this channel: standard samples, unregistered devices imported for registration, devices imported for emergency treatment of a specific patient, a batch imported for clinical research, devices imported for innovative technology or scientific research, exhibits without sales rights, and devices under government programs or humanitarian aid. The common feature of these seven is non-commercial placement, consistent with the logic of the six registration exemptions of Article 16 (Part 07 of this series).

Insight 3: sample imports have a complete chain of legal support.

Read the three provisions together: Article 16 lists device samples used for national registration and standard samples as exempt from registration; Article 30 allows the foreign certificate holder, the manufacturer’s authorized representative office, or a commissioned agent to import for registration and expert review purposes; Article 29 lists standard samples and unregistered devices imported for registration among those eligible for the permit conclusion. Together the three provisions form a complete pre-registration channel. When declaring samples, companies should cite this chain expressly.

Insight 4: the importing entity should match the registration entity.

Article 30 defines the importing entities as the foreign certificate holder, the authorized representative office of the manufacturer, or a commissioned agent. This means the entity declaring the import should sit within the entity chain recorded in the registration dossier. If an unrelated third-party trading company declares on its own, an entity mismatch can arise. We recommend having the authorized representative handle import formalities across the board, or handling them under its coordination.

Insight 5: consumables and peripherals must be registered together, and this is a common sticking point at import.

The multilateral country research states expressly that all devices in use, including peripherals and consumables, must be registered, and that components not listed at initial registration must be registered separately. A registered main unit with unregistered consumables is a high-frequency cause of blocked imports. We recommend including all expected peripherals and consumables in the model list at initial registration (see Part 23 of this series).

4. Practical recommendations

First, check the national register entry immediately after the certificate is issued. We recommend checking five items: device name, type and model list, registration number, holder, and authorized representative. Any discrepancy should be corrected promptly to avoid blocked imports.

Second, prepare the statement of intended use for sample imports in advance. We recommend stating the sample name and models, quantities, the purpose of technical testing, biological effect evaluation, or clinical laboratory testing, the testing institution, and the disposition method of consumption in testing, retention, or return.

Third, include peripherals and consumables in the initial registration. We recommend adding all peripherals and consumables expected to ship with the main unit to the model list at initial registration, avoiding the repeated cost of separate registrations later.

Fourth, keep the importing entity aligned with the registration entity. We recommend having the authorized representative handle import formalities, or having a commissioned agent act under its coordination, so the entity chain matches the registration dossier.

Fifth, build a separate declaration template for permit-conclusion imports. We recommend preparing supporting materials by each of the seven situations: standard samples, unregistered devices imported for registration, emergency-use devices, clinical research batches, research or innovative technology imports, exhibits, and government programs and humanitarian aid.

5. Verification checklist

• □ After issuance, the five register items were checked: device name, type and model list, registration number, holder, authorized representative;
• □ Registered items are imported on the strength of the register entry (Article 29 of Law No. 216);
• □ Items not listed in the register have applied for an import permit conclusion under the seven situations, with corresponding supporting materials;
• □ The statement of intended use for sample imports is ready, covering names and models, quantities, purpose, testing institution, and disposition;
• □ Peripherals and consumables have been included in the model list of the initial registration;
• □ The importing entity matches the entity chain in the registration dossier, handled by the authorized representative or under its coordination.

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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