Kyrgyzstan Medical Device Registration: EAEU Registration Exemption List Update of 2026

1. Key takeaways

On February 9, 2026, the Eurasian Economic Union member states signed a Protocol expanding the list of medical devices exempt from registration at union level. Four new categories were added: devices manufactured to individual order and intended for personal use only; devices brought into the union customs territory under permission of a competent authority in order to provide life-saving medical care to a patient; devices manufactured within a member state for export; and packs, sets, boxes and first-aid kits assembled from already registered devices and medicinal products, intended for circulation only within that state. This list and the national exemption list in Article 16 of Kyrgyzstan’s Law No. 216 operate at different levels and do not replace each other.

2. Legal basis

1. Protocol amending the Agreement of 2014-12-23, signed on February 9, 2026: expands the union-level list of medical devices exempt from registration.
2. The four new categories as recorded in the official account of the Belarusian legislative process (considered by the House of Representatives on June 3, 2026):
   • Medical devices manufactured to individual order and intended for personal use only;
   • Medical devices brought into the union customs territory under permission of a competent authority in order to provide life-saving medical care to a patient;
   • Medical devices manufactured within a member state for export;
   • Packs, sets, boxes and first-aid kits assembled from already registered medical devices and medicinal products, intended for circulation only within that state (assembled under the law of the member state).
3. Law of the Kyrgyz Republic on the Circulation of Medical Devices, Law No. 216 of December 29, 2023, Article 16 (six national-route exemption categories).
4. Public position of the competent authority: devices exempt from registration in the Kyrgyz Republic are determined by Article 16 of Law No. 216.

Source note: the article-by-article original text of the 2026-02-09 Protocol was not available as a verbatim official text in this verification round. The four categories above come from the official account of the Belarusian legislative process and constitute a member state official source; application in Kyrgyzstan must follow the currently effective union text and the currently effective text published by Kyrgyzstan.

3. Expert insights

Insight one: two parallel exemption lists are a structural fact of this market.

Kyrgyzstan runs two routes in parallel, and the direct consequence is two parallel exemption lists: products on the national route are judged against Article 16 of Law No. 216, while products on the union route are judged against the union list under the Agreement of 2014-12-23 and its Protocols. The first step in determining whether a product is exempt is to establish which route it travels; only the second step is checking the corresponding list. Reversing the order leads to citing the wrong instrument.

Insight two: the common feature of the four new categories remains non-entry into ordinary commercial circulation.

Like the six categories of Article 16, the four categories added in 2026 follow one clear logic: individually custom-made devices serve a single named person; emergency-import devices enter under permission to save lives; devices manufactured for export never circulate within the member state; assembled packs and first-aid kits circulate only within that state. None of the four constitutes ordinary commercial placement on a member state market. This logic line can be used to quickly assess the boundary of any new situation.

Insight three: the third category, production for export, has unique value for Chinese manufacturers.

Medical devices manufactured within a member state for export are exempt from union registration. For Chinese companies with plants inside a member state whose output is sold back to China or to other third-country markets, this provision can significantly reduce the compliance burden. Note, however, that the exemption operates at union level: if the product is sold within the member state, it must still be registered under the applicable procedure.

Insight four: the boundaries of the fourth category, assembled packs, demand word-level precision.

The exemption for packs, sets, boxes and first-aid kits carries three qualifications: assembly under the law of the member state; assembly from registered medical devices and medicinal products; and circulation only within that state. All three conditions must be met simultaneously. The second is especially critical: if any device in the pack is unregistered, the exemption does not apply to the pack as a whole. When designing first-aid kits, surgical kits and similar combinations, verify the registration status of every component first.

Insight five: the 2026-02-09 Protocol and the 2025-12-29 Protocol are two parts of one legislative round.

The House of Representatives of Belarus approved both Protocols in the same session on June 3, 2026: the transition-period extension Protocol of 2025-12-29 and the exemption-list expansion Protocol of 2026-02-09. The signal is that in this legislative round the union addressed the dimensions of time and scope together, pushing the transition period back while carving out categories that need no registration, so as to relieve pressure on the system.

4. Practical recommendations

First, run the exemption assessment in two steps. Build two gating questions into the internal process: which route does the product travel, national or union; and which category of the corresponding list applies, with all its preconditions satisfied. Cite the exemption only after both steps pass.

Second, verify component registration status before relying on any combination product. For first-aid kits, surgical kits and diagnostic kits, maintain a component list and verify the registration status and validity of each item. If even one component is unregistered, the exemption does not apply.

Third, assess the export-production exemption separately. If a production facility exists in a union member state and the output is for export, evaluate the third-category exemption on its own terms and confirm the operating interpretation with local counsel.

Fourth, keep written justification for every exemption claim. For each use of an exemption, document the provision cited, the category relied on, the verification of each precondition and the supporting documents. This is the most effective self-evidence in customs and regulatory checks.

5. Verification checklist

• □ Determine whether the product travels the national route or the union route, and select the corresponding exemption list (Article 16 of Law No. 216 versus the union list);
• □ For union-route products: check the four categories under the 2026-02-09 Protocol and confirm each precondition item by item;
• □ For combination products (packs, sets, boxes, first-aid kits): verify the registration status and validity of every component;
• □ Confirm assembly follows the law of that member state and circulation is limited to within that state;
• □ For export production bases: separately assess the applicability of the exemption for manufacturing within a member state for export;
• □ Written justification is retained for every exemption claim (provision cited, category, precondition verification and supporting documents).

Regulatory information verified as of October 29, 2026.

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