Azerbaijan Market Evidence Documents: Foreign Registration Certificate vs Free Sale Certificate

1. Key takeaways

The document route under Article 4.2.2 is a two-option election with a priority order:

4.2.2.1 a document confirming that the device has obtained state registration in the manufacturing country; where no state registration exists in the manufacturing country, a document confirming its state registration in another country or countries;

4.2.2.2 a free sale or export certificate for the device, where one exists.

Whichever option is used, a notarised translation into Azerbaijani must be submitted. Article 4.3 further provides that item 4.2.2 does not apply to devices manufactured in Azerbaijan.

This item is distinct from Article 4.2.1 (proof of the manufacturing right): the former demonstrates that the product is lawfully marketed somewhere, the latter that the manufacturer is entitled to produce it. Confusing the two is a recurring drafting error.

2. Legal basis

• Resolution No. 345 of the Cabinet of Ministers of the Republic of Azerbaijan dated 18 July 2024 on the Rules for State Registration of Medicines, Drug Substances and Medical Devices, Their Entry into the State Register and Maintenance of the State Register (effective 19 July 2024; Xalq qəzeti No. 151 of 20 July 2024; Legislative Bulletin 2024 No. 7, item 906; repealing Resolution No. 108 of 13 July 2007 as of 20 July 2024): Article 4.2.1 (manufacturing right proof and annexes), Article 4.2.2.1 (manufacturing-country registration certificate or other-country certificate), Article 4.2.2.2 (free sale or export certificate), Article 4.2.2 (notarised Azerbaijani translation requirement), Article 4.3 (local production exemption), Article 5.1.2 (refusal where untrue information is found in the submitted documents).
• Resolution No. 480 of the Cabinet of Ministers of the Republic of Azerbaijan dated 26 December 2023 (the list of states and international organisations whose foreign (international) registrations are recognised) — the list of recognised foreign registrations, applicable only to medicines; devices do not fall under Article 6-2.
• Law of the Republic of Azerbaijan on Medicines (Law No. 208-IIIQ, adopted 22 December 2006, effective 28 February 2007, Legislative Bulletin 2007 No. 2, item 70), as amended by Law No. 979-VIQD of 14 July 2023 (adding Articles 1-1 and 9-1, Legislative Bulletin 2023 No. 8, item 1127): Article 1-1 (Article 6-2 does not apply to devices).

3. Expert insights

Insight one: the manufacturing-country-first rule of Article 4.2.2.1 is an ordering rule that is often overlooked. The text reads: a certificate of state registration in the manufacturing country; where the country has not performed state registration, a certificate of registration in other countries. Submitting a third-country certificate while a manufacturing-country certificate exists may be questioned as circumvention. Conversely, where the manufacturing country does not register a category (for example, some Class I filing products from the Chinese mainland), the dossier must state the fact that the manufacturing country does not perform state registration before an other-country certificate is offered.

Insight two: the phrase where available in Article 4.2.2.2 is a fallback, not a parallel alternative. Free sale or export certificates only come into play when 4.2.2.1 documents cannot be obtained, and they attest to free sale, a weaker standard than state registration. When relying on one, attach a cover note explaining why Article 4.2.2.1 documents cannot be provided.

Insight three: Azerbaijan has no recognition fast lane for foreign device registrations. Article 1.7 of the Rules does contain a recognition mechanism for foreign (international) registrations, but it rests on Article 6-2 of the Law on Medicines and the Cabinet Resolution No. 480 list — and Article 1-1 excludes Article 6-2 for devices. Therefore holding CE marking or a US 510(k) does not replace local state registration; it only serves as one source of documents under Article 4.2.2.

Insight four: the notarisation in the notarised translation points to certification of the translator’s signature or the translated copy. Article 4.2.2 uses the wording of a copy translated into Azerbaijani through notarial procedure. The practical estimate is that translation certification should be done by a notary inside Azerbaijan; translations certified abroad need confirmation of acceptance by AEC (pending verification, confirm in writing before submission).

Insight five: the price of untruthful documents is refusal, not deficiency notice. Article 5.1.2 makes untrue information found in the submitted documents a ground for refusal. Validity periods, scope and product names on registration certificates and FSCs must match the rest of the dossier; an expired certificate cannot simply be submitted and corrected later.

4. Practical recommendations

1. Prepare documents in the order manufacturing-country certificate, other-country certificate, FSC, and state the reason for the chosen route in the dossier.
2. Where the manufacturing country does not register the category, prepare a written statement with official supporting references before offering an other-country certificate.
3. Have translation certification done by a notary inside Azerbaijan; for certifications completed abroad, confirm acceptance with AEC in writing first.
4. Before submission, verify that product names, models and the manufacturer name on certificates and FSCs match the rest of the dossier verbatim.
5. Check validity periods of registration certificates and FSCs; if a document is expired, delay submission rather than submit it.
6. Do not invoke Article 1.7 or Resolution No. 480 to seek recognition of foreign registrations for devices.

5. Verification checklist

• □ The 4.2.2.1 or 4.2.2.2 document route has been fixed and the choice reasoned in writing.
• □ Notarised Azerbaijani translations are complete (preferably certified by a domestic notary).
• □ Names, models and manufacturer details on certificates and FSCs match the dossier.
• □ All documents remain valid on the submission date and throughout the expected review period.
• □ Where the manufacturing country does not register the category, a written statement with official references is attached.
• □ Any route relying on Article 1.7 or Resolution No. 480 has been excluded.

• Article 13 — The 11 dossier items one by one: 4.2.1 to 4.2.11: https://www.grzanglobal.com/azerbaijan-medical-device-registration/dossier-11-items-breakdown/
• Article 15 — Additional documents for sterile devices: validation, bioburden, pyrogenicity and sterility: https://www.grzanglobal.com/azerbaijan-medical-device-registration/sterile-device-additional-documents/
• Article 22 — The manufacturer manufacturing-right document and its annexes: https://www.grzanglobal.com/azerbaijan-medical-device-registration/manufacturer-production-right-document/

Regulatory information verified as of October 30, 2026.

GRZAN supports manufacturers and authorised representatives in selecting and documenting the Article 4.2.2 route for medical devices in Azerbaijan, from manufacturing-country certificate strategy and notarised translation logistics to consistency reviews across the dossier. For tailored assistance with your Azerbaijan market evidence documents, contact us at info@grzanglobal.com.