Azerbaijan Medical Device Registration Authority: Ministry of Health and AEC Explained

1. Key takeaways

For medical devices in Azerbaijan, the certificate issuer is the Ministry of Health (Səhiyyə Nazirliyi) and the technical assessment body is the Analytical Expertise Center, AEC (Analitik Ekspertiza Mərkəzi). These are two distinct roles rather than one institution: the dossier is submitted to the Ministry of Health, the technical expertise is carried out by AEC under Resolution No. 502, the certificate is issued by the Ministry of Health, and the state register is maintained by the Ministry of Health through AEC. For foreign manufacturers there is only one submission window, which is the Ministry of Health, but the technical success or failure of a project is decided mainly during the AEC stage.

Article 1.6 of Resolution No. 345 states this division of labor plainly: medicinal products, drug substances and medical devices are registered by the Ministry of Health and entered into the state register, and only after registration are import, domestic manufacture, sale and use permitted. Article 4.1 splits device registration into three stages: submission of the application under Part 4, expertise performed by the body (Qurum) under Resolution No. 502, and issuance of the certificate under Part 7. The term body (Qurum) used throughout the Rules refers in practice to AEC.

2. Legal basis

• Resolution No. 345 of the Cabinet of Ministers of the Republic of Azerbaijan of July 18, 2024, approving the Rules on State Registration of Medicinal Products, Drug Substances and Medical Devices, Entry into the State Register and Maintenance of the State Register (effective July 19, 2024; Xalq qəzeti No. 151 of July 20, 2024; Legislative Collection of the Republic of Azerbaijan, 2024, No. 7, item 906; repealing Resolution No. 108 of July 13, 2007 with effect from July 20, 2024): Article 1.6 (registration and entry into the state register by the Ministry of Health; after registration, import, domestic manufacture, sale and use are permitted), Article 4.1 (three stages: application, expertise, certificate issuance), Article 10.1 (the register is maintained by the Ministry of Health through the body), Article 10.7 (register data published on the official websites of both the Ministry of Health and the body).
• Law of the Republic of Azerbaijan on Medicinal Products (Dərman vasitələri haqqında, No. 208-IIIQ, adopted December 22, 2006, effective February 28, 2007, Legislative Collection of the Republic of Azerbaijan, 2007, No. 2, item 70), as amended by Law No. 979-VIQD of July 14, 2023 (adding Articles 1-1 and 9-1 as new provisions, Legislative Collection 2023, No. 8, item 1127): Article 6.8 first sentence (the rules on state registration, entry into the register and register maintenance are adopted by the body determined by the relevant executive authority), Article 6.8 second sentence (the risk-based classification of devices is determined by that body).
• Resolution No. 502 of the Cabinet of Ministers of the Republic of Azerbaijan of December 25, 2019, on the Rules for Conducting Expertise of Medicinal Products (including simplified expertise) (Xalq qəzeti No. 290 of December 28, 2019; Legislative Collection 2019, No. 12, item 2083; effective July 1, 2020) (the basis for conducting expertise, with AEC as the assessment body).
• Resolution No. 347 of the Cabinet of Ministers of the Republic of Azerbaijan of July 20, 2024 (amending the expertise rules of Resolution No. 502 to bring medical devices within the scope of expertise and quality control; the amended version effective July 20, 2024) (amendment of the expertise rules, inclusion of devices).

3. Expert insights

Insight 1: the separation between the submission window and the assessment body is the first variable in scheduling. The applicant submits materials to the Ministry of Health, but Article 4.1 makes clear that the expertise is performed by the body, and Article 7.12 provides that the review period for the certificate application of the applicant is not counted within the period of mandatory expertise of drug substances referred to in Article 4.4. In other words, for devices containing drug substances, the expertise time is added on top of the certificate issuance period, and back-planning the entire chain from the 7 working days of issuance will seriously underestimate the timeline.

Insight 2: the term body (Qurum) in the Rules is a statutory designation, not a loose reference. The Qurum that appears repeatedly in Articles 4.1, 4.4, 4.5, 10.1 and 10.7 is presented on the AEC official website, in its regulatory section, side by side with Resolution No. 502 on the Rules for Conducting Expertise of Medicinal Products, and in practice it is the Analytical Expertise Center. The Rules avoid naming it directly because the status of the body is established by a Cabinet resolution rather than by these Rules themselves, so this wording protects the Rules from becoming invalid if the institution is renamed.

Insight 3: registration unlocks four rights at once; it is not only about import. The wording of Article 1.6 is that after registration, import into the country, domestic manufacture, sale and use are permitted. A single registration opens all four actions simultaneously. This means that in an unregistered state even domestic manufacture is unlawful, so for local contract manufacturing models the compliance risk sits at the registration stage, not at the import stage.

Insight 4: dual-site publication of the register puts data consistency under a spotlight. Article 10.7 requires register data to be published simultaneously on the official websites of the Ministry of Health and AEC. Certificates, packaging descriptions and instructions for use are uploaded in electronic format under Article 10.5. Once a label or instructions for use differ from the actual goods, any purchaser can detect the mismatch by comparing the public entries.

4. Practical recommendations

1. Build a dual-node ledger covering the Ministry of Health and AEC: submission receipts are based on documents issued by the Ministry of Health, while technical queries and deficiency notices are based on documents issued by AEC; keep records at the two nodes separately.
2. When scheduling, strip out the expertise period for devices containing drug substances as a separate item and do not merge it with the 7 working days certificate issuance period.
3. Use the terms body (Qurum) and AEC together in all external correspondence, so that translations do not diverge from official wording and get rejected.
4. State in advance in contracts and authorization letters that the four rights of import, manufacture, sale and use arise only after registration is completed, and that distributors must not place goods on the market before the registration date.
5. Before submission, check the latest acceptance announcements and dossier checklists published on the AEC official website; the official section is updated before any secondary channel.
6. Appoint an Azerbaijani-language reviewer responsible for cross-checking the public register fields against physical labels and instructions for use.

5. Verification checklist

• □ Confirmed that the certificate issuer for this project is the Ministry of Health and the assessment body is AEC, and recorded this in the internal schedule.
• □ Checked the start dates of the four post-registration rights under Article 1.6 (import, domestic manufacture, sale, use).
• □ Confirmed whether the product falls under Article 4.4 (drug substances) and scheduled the expertise period separately on that basis.
• □ Retained templates for both types of documents: Ministry of Health submission receipts and AEC deficiency notices.
• □ Appointed an Azerbaijani-language reviewer able to compare public register fields with physical labels.
• □ Confirmed the public scope of the register (Ministry of Health website plus AEC website) and included it in post-market inspections.

Related reading

• Article 02. From Devices Equated with Medicines to Mandatory Registration: the 2023 Amendment and the 2024 Rules: https://www.grzanglobal.com/azerbaijan-medical-device-registration/device-equated-with-medicine-mandatory-registration/
• Article 04. How to Read Resolution No. 345: a Structural Guide to 13 Parts: https://www.grzanglobal.com/azerbaijan-medical-device-registration/resolution-345-rules-structure-guide/
• Article 11. The Full State Registration Process: Application, Expertise and Certificate in Three Stages: https://www.grzanglobal.com/azerbaijan-medical-device-registration/state-registration-full-process/
• Article 12. Classification Determination Before Submission: How to Use the Grading Rules of Decision No. 8: https://www.grzanglobal.com/azerbaijan-medical-device-registration/classification-determination-before-submission/

This article was translated and published by GRZAN, the international regulatory affairs service of GRZAN Global. For professional support with medical device registration in Azerbaijan, regulatory strategy, dossier preparation and local representation, contact us at info@grzanglobal.com.

Regulatory information verified as of October 30, 2026.