Kyrgyzstan Medical Device Definition: Dedicated Software and IVD Devices under Law No. 216

1. Key takeaways

The definition of a medical device in Kyrgyzstan is set out in Law No. 216 of December 29, 2023, On the Circulation of Medical Devices. Three points are worth noting at the outset: dedicated software is expressly written into the device definition and is not an accessory; in vitro diagnostic devices have their own separate definition, placed alongside therapeutic devices; and the core test for a device is that its intended function is not achieved by pharmacological, immunological, genetic or metabolic means. This law replaced Law No. 166 of August 2, 2017 with effect from January 12, 2024.

2. Legal basis

1. Law of the Kyrgyz Republic On the Circulation of Medical Devices, No. 216 of December 29, 2023 — the device definition, the in vitro diagnostic definition, state registration (Article 14), the attributes of the registration certificate (Article 15), exemptions from registration (Article 16), inspections (Article 18), and import and prohibitions on import (Articles 29–31).
2. Part 3 of Article 34 of that law: Law No. 166 of August 2, 2017, On the Circulation of Medical Products, ceases to be effective from January 12, 2024.
3. Cabinet Resolution No. 513 of August 27, 2024, Article 2 of Annex 1 — definitions of the type of medical device, the model, the accessory, the production site and other concepts.
4. Public information of the competent authority website: devices exempt from registration are determined by Article 16 of Law No. 216.

3. Expert insights

Insight 1: the words including dedicated software in the definition carry enormous value.

Law No. 216 expressly includes dedicated software (включая специальное программное обеспечение) in the device definition. This means that software as a medical device (SaMD) does not require any additional argument about whether it is a device in Kyrgyzstan — the law has already answered that question. For companies, the real difficulty shifts to two other places: first, how software version numbers are defined and changed within the registration dossier, and second, whether an algorithm update triggers a change procedure or a new registration. We expand on this point specifically in Article 29 of this series.

Insight 2: the outer boundary is drawn by the mechanism of action, not by the product name.

The core test under the law is that the intended function is not achieved through pharmacological, immunological, genetic or metabolic means, consistent with the approach of the European Union and international harmonization bodies. In practice, drug-device combinations and combination products containing biological materials are the products most likely to fail this test — once the mechanism of action includes a pharmacological or metabolic pathway, the product may fall outside the device scope and move to the medicinal product pathway. The qualification of a combination product must be settled at the project initiation stage; do not wait until after acceptance to remedy it.

Insight 3: in vitro diagnostics have a separate definition, and the coverage is broader than commonly assumed.

Law No. 216 gives in vitro diagnostic devices a definition of their own, covering instruments, apparatus, equipment, materials, reagents, calibrators, control materials and other products, including dedicated software intended specifically for in vitro examination, together with information on physiological or pathological states, congenital abnormalities, susceptibility to a specific clinical condition or disease, and histocompatibility. In other words, reagents, calibrators, control materials and associated software form one system: a manufacturer cannot register only the instrument and omit the reagents, nor register only the reagents and omit the software.

Insight 4: three groups of concepts added by Cabinet Resolution No. 513 directly determine how many models one dossier can hold.

Article 2 of Annex 1 defines the type of medical device (a group of devices with the same or similar intended purpose and/or design), the model (a product variety developed on the basis of the parent product in terms of design characteristics, used to improve, extend or specialize its application), and the accessory (a product that is not itself a device but is intended by the manufacturer to be used together with one or more devices). These three concepts determine whether a single registration dossier can accommodate multiple models and whether an accessory requires separate registration. We explain the method for judging dossier capacity in Article 23 of this series, together with the GMDN nomenclature.

4. Practical recommendations

First, treat software products as devices from the start, leaving no gray area. Standalone software is a device in Kyrgyzstan and must undergo state registration. We recommend fixing, in the technical documentation, the formulation of three elements — the software version number, the algorithm version and the intended purpose — to leave a clean interface for later changes.

Second, for combination products, settle the qualification first and the registration pathway second. For products containing drugs, biological materials or human-derived components, seek written confirmation of the qualification from the receiving department before project initiation and archive the reply. The cost of a wrong qualification decision is a complete restart of the pathway.

Third, build the IVD dossier as one complete system. The instrument, reagents, calibrators, control materials and software should be presented together in a single registration dossier, with the registration status and combination relationships of each component clearly stated. Splitting the submission easily results in components being placed on the market without registration.

Fourth, treat accessories and spare parts differently. Article 16 of Law No. 216 provides an exemption for spare parts, components and accessories of devices previously imported, but that exemption carries strict preconditions (see Article 07 of this series). Accessories designated by the manufacturer and after-sales spare parts occupy different positions under the law and should not be conflated in dossier preparation.

5. Verification checklist

• □ Obtain the currently valid text of Law No. 216 (current version dated November 3, 2025 in the Ministry of Justice legal database) and verify the device definition and the IVD definition line by line;
• □ Confirm that the mechanism of action of the product does not rely on pharmacological, immunological, genetic or metabolic means, and that the qualification of any combination product has been completed;
• □ For software products: confirm that the version number, algorithm version and intended purpose have been fixed in the documentation;
• □ For IVD products: confirm that the instrument, reagents, calibrators, control materials and software are all included in the dossier, with no component omitted;
• □ Confirm the division into types, models and accessories for the product combination to be registered;
• □ Confirm that Law No. 166 of August 2, 2017 has ceased to be effective and is no longer cited.

Regulatory information verified as of October 29, 2026.

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