Kyrgyzstan Medical Device Registration: Language and Notarization Requirements

1. Key takeaways

For device registration documents in Kyrgyzstan, language and legalization are two parallel thresholds. On language: the forms, announcements and regulatory explanations on the competent authority website are published in Kyrgyz and Russian, and registration practice operates mainly in Russian; labels and instructions for use must be provided in Russian and/or Kyrgyz. On legalization: documents executed abroad — powers of attorney, free sale certificates, quality management system certificates and the like — must complete notarization and legalization, together with translation, before they can be used. Improper handling of these two thresholds is a frequent cause of deficiency letters at the acceptance stage.

2. Legal basis

1. Law of the Kyrgyz Republic On the Circulation of Medical Devices, No. 216 of December 29, 2023.
2. Cabinet Resolution No. 513 of August 27, 2024, Annexes 1 and 2; the text of the resolution is published in Kyrgyz and Russian.
3. Medical device section of the competent authority (the Department of Medicines and Medical Products of the Ministry of Health) website: forms, explanations and regulatory links are provided in both Kyrgyz and Russian versions.
4. Article 2 of Annex 1 to Cabinet Resolution No. 513: the authorized representative of the manufacturer must be authorized under a power of attorney from the manufacturer.
5. Published forms of the competent authority: Annex 1 (registration application form), Annex 2 (change application form), Annex 10 (declaration of responsibility for the truthfulness of information).

Note on sources: the language requirements for labels and instructions for use are expressed in different sources as Russian and/or Kyrgyz, and the exact mandatory scope was not obtained this cycle in the form of quotable official detailed rules. The statements below follow the currently valid requirements.

3. Expert insights

Insight 1: the bilingual environment is not a choice of either language; it is a two-layer requirement.

Kyrgyz is the state language and Russian is the official language. In registration practice this dual structure appears as follows: regulatory communication and document submission operate mainly in Russian, while labels and instructions for use, which face end users, may require Kyrgyz. When preparing labels, companies should not simply make a choice between a Russian version and a Kyrgyz version; the language combination should be confirmed separately for each product category and sales scenario. Our practice is to seek confirmation from the authorized representative before the label is finalized and to rely on the written reply.

Insight 2: translation quality is a technical compliance issue, not a linguistic one.

Under Law No. 216, the definitions of the device, the intended purpose, contraindications and warnings all carry regulatory meaning. Inaccurate translation produces two kinds of consequences: clarification requests during review that extend the timeline, and divergence between the label and the registration dossier after approval, which constitutes an information risk under Article 15. We recommend that translations be done by translators with a medical device regulatory background, not by general-purpose translation vendors.

Insight 3: the sequence of the legalization chain cannot be reversed.

The typical processing chain for foreign documents is: original, notarization, legalization, translation, notarization of the translation where required. Reversing the order leads to rework. Take the power of attorney as an example: it must first be signed by the manufacturer and notarized and legalized, and only then translated into Russian. If it is translated first and legalized afterwards, the legalizing authority certifies the translation rather than the effect of the original, which is usually not accepted.

Insight 4: for documents used more than once, plan the number of copies and the validity in advance.

Free sale certificates, quality management system certificates and powers of attorney are often used simultaneously for several markets or projects. We recommend, when obtaining them:

• obtaining sufficient originals in one go, including legalized copies and translations;
• tracking the validity of the documents themselves and the term of authorization in the power of attorney;
• retaining color scans and the numbers of the legalized copies for later verification.

Insight 5: a full round of information consistency checking should be completed before submission.

The manufacturer name, address, models and specifications in the registration dossier must match the free sale certificate, the quality management system certificate, the power of attorney, the labels and the instructions for use word for word. We recommend a five-document comparison before submission: the application form, the power of attorney, the free sale certificate, the quality system certificate, and the label and instructions for use. The cost of this round of checking is far lower than the back-and-forth of deficiency letters after acceptance.

4. Practical recommendations

First, build a document template library and a terminology glossary. For each company’s core products, build a Russian terminology glossary that fixes the Russian wording of product names, model naming, intended purpose and warnings, and apply it consistently across the project. Once the glossary exists, translation and review costs for subsequent products drop significantly.

Second, finalize labels and instructions for use early in dossier preparation. The label is part of the registration dossier and, after approval, an object of inspection in circulation. Finalize it during technical documentation preparation to avoid triggering a change procedure by modifying the label after approval.

Third, reserve time for the legalization chain. Notarization, legalization, translation and review each take time, and some steps depend on domestic processing cycles. List them as a separate line in the project schedule (see Article 20 of this series) and do not compress them in parallel with technical documentation work.

Fourth, retain the complete documentary chain as evidence. This includes color scans of originals, notarial certificates, legalization certificates, translations, and proof of the qualifications of the translator or translation agency. These materials may not be submitted at the acceptance stage, but they will be requested during later changes, inspections or dispute handling.

5. Verification checklist

• □ Confirm the language versions of the current forms of the competent authority, and download both the Kyrgyz and Russian versions for cross-reference;
• □ The specific language requirements for labels and instructions for use (Russian, Kyrgyz, or both) have been confirmed in writing with the authorized representative;
• □ Translations were completed by translators with a medical device regulatory background, and a Russian terminology glossary exists;
• □ The legalization chain for foreign documents follows the correct order: original, notarization, legalization, translation;
• □ The five-document comparison has been completed — application form, power of attorney, free sale certificate, quality system certificate, labels and instructions for use — verifying manufacturer name, address, models and specifications word for word;
• □ The documentary chain evidence (scans of originals, notarial certificates, legalization certificates, translations, and translator or agency qualifications) has been fully archived.

Regulatory information verified as of October 29, 2026.

Our services cover pre-market pathway selection and feasibility assessment, registration dossier preparation and submission, authorized representative arrangements, local testing and clinical trial organization, production site inspection coordination, quality management system conformity support, post-market surveillance and device vigilance system setup, import and distribution compliance, official fee calculation and project budget management.

The GRZAN regulatory team consists of professionals with many years of hands-on experience in Eurasian Economic Union registrations. We maintain a stable local cooperation network in Bishkek, Almaty, Tashkent and Moscow, work in Chinese, Russian and English, and provide executable solutions for the issues foreign manufacturers most often encounter in CIS markets, including authorized representative arrangements, the notarization and legalization chain for powers of attorney, localization of technical documentation, and inspection readiness.

We adhere to one principle: every regulatory conclusion we publish must rest on verifiable official sources. Figures and timelines that cannot be verified are always marked as practical estimates, and experience-based values are never presented as legal requirements.

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

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