Azerbaijan Medical Device Registration 2026: Manufacturer Production Right Document and Annexes

1. Key takeaways

Article 4.2.1 requires a copy of the document proving the manufacturing right of the device manufacturer, together with copies of its annexes, and this is the first item of the eleven-item dossier. Article 4.3 provides that this item (together with 4.2.2, 4.2.8 and 4.2.9) does not apply to devices manufactured within the territory of Azerbaijan.

This item is a different matter from the quality management system certificate under Article 4.2.9: item 4.2.1 proves the right to manufacture, while 4.2.9 proves that manufacturing is managed under a system. The former is usually a manufacturing licence, establishment registration or business licence type document from the country of the manufacturer, while the latter is usually an ISO 13485 certificate. Both are copies filed under Article 4.2, and both are checked for consistency with the other dossier documents during the review.

2. Legal basis

• Resolution No. 345 of the Cabinet of Ministers of the Republic of Azerbaijan of July 18, 2024 on the Rules for the State Registration of Medicinal Products, Drug Substances and Medical Devices, Their Entry in the State Register and the Maintenance of the State Register (effective July 19, 2024; Xalq qəzeti No. 151 of July 20, 2024; Legislative Compilation 2024, No. 7, item 906; repealing Resolution No. 108 of July 13, 2007 as of July 20, 2024): Article 4.2.1 (proof of the manufacturing right and its annexes), Article 4.2.9 (QMS certificate), Article 4.3 (local production exempts 4.2.1, 4.2.2, 4.2.8 and 4.2.9), Article 5.1.2 (untrue information is a ground for rejection), Article 5.1.4 (inconsistent documents are a ground for rejection).
• Law of the Republic of Azerbaijan on Licences and Permits (Lisenziyalar və icazələr haqqında), No. 176-VQ of March 15, 2016, Articles 18.2.1 to 18.2.3, Article 19.9, Article 25 and Article 26.1: Article 18.2.1 (legal entities, or branches or representative offices of foreign legal entities, submit an extract from the state register of legal entities).
• Law of the Republic of Azerbaijan on Medicinal Products (Dərman vasitələri haqqında), No. 208-IIIQ, adopted December 22, 2006, effective February 28, 2007, Legislative Compilation 2007, No. 2, item 70, as amended by Law No. 979-VIQD of July 14, 2023 (adding Articles 1-1 and 9-1 with new wording, Legislative Compilation 2023, No. 8, item 1127): Article 1.0.12 (definition of a medicinal product manufacturer, for comparison), Article 1-1 (list of articles applicable to devices).

3. Expert insights

Insight 1: The clause refers to the document and its annexes, so the annexes must not be omitted. The wording of Article 4.2.1 is a copy of the document proving the manufacturing right and of its annexes. Many manufacturing licence documents state only the company name and the licensed scope in the main certificate, while the specific product categories appear in the annexes, such as schedules or lists of licensed products. Submitting only the main certificate will be regarded as an unclear coverage scope, which can trigger the defect notice under Article 7.3 and consume part of the ten-working-day correction window under Article 7.4.

Insight 2: What is exempted is local production, not a local applicant. The wording of Article 4.3 is medical devices manufactured within the territory of the Republic of Azerbaijan. If the product is manufactured by a foreign manufacturer and the application and the certificate are held by a local Azerbaijani company, item 4.2.1 cannot be exempted. Conversely, if the product is manufactured inside Azerbaijan, the item may be exempted even when the applicant is a foreign-invested enterprise. The decisive fact is the place of manufacture, not the place of incorporation of the applicant.

Insight 3: The proof of manufacturing right and the foreign registration certificate under Article 4.2.2 form two independent chains of evidence. Item 4.2.1 proves that the manufacturer can produce, and 4.2.2 proves that the device is already on the market elsewhere. Both are required, except in local production cases where both items are exempt. The problems most often seen in practice are that the product scope stated in the manufacturing right document is narrower than the product applied for, or that the company name differs from the manufacturer name shown on the registration certificate filed under 4.2.2.

Insight 4: The authenticity risk of this item connects directly to Article 5.1.2. An expired manufacturing licence, a revoked licence, or a licensed address that does not match the actual manufacturing address all amount to untrue information found in the submitted documents. The criminal-liability statement in the Annex 1 application form is aimed precisely at documents of this kind, and any such finding is also a ground for rejection.

Insight 5: Multiple manufacturing sites require special handling. Where the same product has several actual manufacturing sites, the proof of manufacturing right must cover the sites declared in the application. The certificate form in Annex 5 prints only a single manufacturer, country and address field, so multiple sites cannot be fully reflected on one certificate. Practical estimate: register under the main manufacturing site and manage the other sites as changes (pending verification; written confirmation from the AEC is recommended before relying on this approach).

4. Practical recommendations

1. Submit the proof of manufacturing right together with its annexes, and make sure the annexes show coverage of the product categories applied for registration.
2. Check that the company name and address in the manufacturing right document, the registration certificate under 4.2.2 and the QMS certificate under 4.2.9 are identical across all three documents.
3. Confirm that the document is valid on the filing date and throughout the expected review period; renew an expired document before filing.
4. In local production cases, expressly invoke the exemption of Article 4.3 for item 4.2.1 in the covering letter and attach evidence of production within Azerbaijan.
5. For multiple manufacturing sites, register under the main site, bring the other sites under change management, and confirm the practical estimate with the AEC in writing.
6. Include the manufacturing right document in the annual self-check list, and file a change of state registration under Article 1.5 whenever it changes.

5. Verification checklist

• □ The main proof of manufacturing right and its annexes, including product category coverage, have been submitted.
• □ The name and address in the manufacturing right document have been checked against the documents under 4.2.2 and 4.2.9.
• □ The document has been confirmed valid throughout the review period.
• □ In local production cases, the exemption under Article 4.3 has been invoked in the covering letter.
• □ For multi-site cases, the main site has been determined and the practical estimate confirmed with the AEC.
• □ The manufacturing right document has been included in the annual self-check list.

Related reading: Application Form (Annex 1): Completion Points and the Criminal-Liability Declaration (https://www.grzanglobal.com/azerbaijan-medical-device-registration/application-form-annex-1/); Brief Description: Scope, Purpose and Accessories (https://www.grzanglobal.com/azerbaijan-medical-device-registration/brief-description-scope-purpose-accessories/); Quality Management System Certificate: Exempted for Local Production (https://www.grzanglobal.com/azerbaijan-medical-device-registration/quality-management-system-certificate/).

GRZAN provides regulatory consulting for medical device manufacturers and exporters, covering Azerbaijan state registration dossiers, manufacturing right documentation, quality management system evidence and post-market change management. For tailored support on this topic, contact GRZAN at info@grzanglobal.com.

Regulatory information verified as of October 30, 2026.