Kyrgyzstan Medical Device Registration Exemptions: The Six Categories under Article 16

1. Key takeaways

Article 16 of Law No. 216 lists the situations in which devices may be used without state registration — six categories in total. The competent authority expressly confirms on its website that devices exempt from registration in the Kyrgyz Republic are determined by Article 16 of that law. Each of the six categories carries its own preconditions, and two of them — spare parts and samples — are the most easily misapplied: the spare parts exemption applies only to parts of devices previously imported into Kyrgyzstan, so it cannot be stretched to cover a new product, and the sample exemption applies only to import for registration purposes, not to goods offered for sale.

2. Legal basis

1. Law of the Kyrgyz Republic On the Circulation of Medical Devices, No. 216 of December 29, 2023, Article 16: situations in which medical devices are exempt from state registration.
2. Public information of the competent authority (the Department of Medicines and Medical Products of the Ministry of Health) in the medical device section of its website: medical devices exempt from registration in the Kyrgyz Republic are determined by Article 16 of Law No. 216.
3. Article 29 of Law No. 216: devices that are registered and entered in the national register are imported on the basis of the register entry; devices not entered in the register require an import permission conclusion issued by the regulatory body, under a procedure established by the Cabinet.
4. Article 30 of Law No. 216: the holder of a foreign registration certificate, the representative office of the manufacturer, or an entrusted person may handle import for registration and assessment purposes.

Note on sources: the verbatim official text of each paragraph of the six categories in Article 16 was not obtained in a quotable form for this cycle. They are therefore presented below as a list, and concrete application must follow the currently valid legal text.

3. Expert insights

Insight 1: the essence of the six-category list is exclusion by purpose of circulation.

Reading the six categories one by one — domestically produced devices made to individual order for personal use only; device samples intended for state registration; standard samples; spare parts, components and accessories of previously imported devices; anatomical, medical and anthropomorphic models; and devices brought in by individuals for their own use — a common thread emerges: none of them enters the ordinary commercial circulation chain. Devices made to individual order do not enter the market, samples do not enter the market, models are not used in clinical care, and personally carried devices are only for the carrier. This thread is more useful than memorizing the list: when judging whether a product can be exempted, first ask whether it enters commercial circulation.

Insight 2: the preconditions of the spare parts exemption are the easiest to overlook and the easiest to trip over.

Article 16 formulates the spare parts exemption with a strict qualifier: spare parts, components and accessories of devices previously imported into Kyrgyzstan. This means that if a model has never been imported into the country, its spare parts have no basis for exemption and must be registered together with the main device or separately. A mistake Chinese manufacturers often make is to ship newly added spare parts and consumables after the main device has been registered, assuming that a registered main device automatically opens the door for accessories. Under Article 29 of Law No. 216, goods with no register entry and no import permission conclusion will not be released by customs.

Insight 3: the sample exemption and import for registration purposes are designed as a matched pair.

Article 16 lists device samples intended for state registration as an exempt situation; Article 30 allows the holder of a foreign registration certificate, the representative office of the manufacturer or an entrusted person to handle import for registration and assessment purposes; and Article 29 lists unregistered devices imported for registration among the situations eligible for an import permission conclusion. Together, the three provisions form a complete pre-registration channel: samples may come in, but only for registration, not for sale. In the declaration, the use, quantity and disposition of the samples (consumed in testing, retained, or re-exported) must be stated.

Insight 4: the model exemption has a clear boundary — no clinical use.

Anatomical models, medical models and anthropomorphic phantoms are on the exemption list on the premise that they are used for teaching, display or demonstration and perform no diagnostic or therapeutic function. Once a model is claimed to have diagnostic support functions — for example, a simulation phantom for imaging training that carries quantitative parameters — its qualification may shift from model to device. Qualification comes first; the citation of the exemption comes second.

Insight 5: there is a separate Union-level exemption list, and the two lists operate on different levels.

The Protocol signed on February 9, 2026 expanded the range of devices exempt from registration at the Union level, adding, among others, personally customized devices, devices imported under permission of the competent authority to save lives, devices produced within a member state for export, and kits, sets, boxes and first-aid kits assembled from registered devices and medicinal products (see Article 18 of this series). Article 16 governs the national track of Kyrgyzstan; the Protocol governs the Union track; neither list substitutes for the other.

4. Practical recommendations

First, build an exemption assessment sheet and complete it before every shipment. For each non-registered consignment, fill in the sheet: product description, the specific category of Article 16 relied upon, whether the preconditions are met, and the supporting documents. Have it signed and retained by the authorized representative as the basis for customs and regulatory checks.

Second, manage spare parts and new accessories separately. When registering the main device, include as many anticipated spare parts and consumables as possible in the registration dossier; anything not included must be registered separately. Do not use the registration of the main device as the basis for importing spare parts.

Third, make the statement of use for sample imports specific. State the name and model of the samples, the quantity, the use (technical testing, biological effects evaluation, or clinical laboratory trials), the testing institution, and the disposition. Vague declarations invite requests for supplementary materials, or even classification as commercial import.

Fourth, do not exaggerate the claimed functions of model-type products. Function descriptions in instructions for use, promotional materials and labels should stay consistent with the model or demonstration positioning, and should avoid terms such as diagnosis, screening or quantitative assessment.

5. Verification checklist

• □ Compare the six categories of Article 16 item by item and confirm that the product to be exempted falls into a specific category;
• □ For spare parts: confirm that the corresponding main device model has previously been imported into Kyrgyzstan, and retain the import evidence;
• □ For samples: confirm that the use is state registration purposes, and prepare a statement of the use, quantity, testing institution and disposition;
• □ For models: confirm that they are not used for diagnosis or treatment, and that promotional materials contain no diagnostic, screening or quantitative assessment wording;
• □ For personally carried devices: confirm personal use only, in reasonable quantities;
• □ For Union-track projects: separately verify the Union-level exemption list under the Protocol of February 9, 2026; the two lists apply independently.

Regulatory information verified as of October 29, 2026.

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