GRZAN Azerbaijan Medical Device Registration Services: Scope, Method and Local Support

1. Key takeaways

GRZAN services in Azerbaijan cover every stage addressed by this 50-article series: classification determination and route design (Decision No. 8, Decision No. 7), State registration dossier preparation and submission (the 11 items of Article 4.2 of Rules No. 345), local certificate holder arrangements and document landing points (the certificate holder fields of Annex 5, Articles 18.2.1 to 18.2.3 of the Licenses and Permits Law), Azerbaijani-language translation and notarisation (items 4.2.2, 4.2.7 and 9.1), certificate issue and deficiency remediation follow-up (Articles 7.1, 7.3 and 7.4), import permits and temporary import (Articles 9-1.9, 9-1.7 and 9-1.8 of the Law on Medicines), changes and renewal (Articles 1.5, 7.8 and 7.9), and post-market consistency and vigilance maintenance (Parts 11 and 12, Resolution No. 503).

Our working method is to map the three layers of Azerbaijani legal sources — the Law, the Rules and the ministerial decisions — article by article onto a single project list, so that every deliverable corresponds to a specific article number and no position is stated without a source.

2. Legal basis

• Resolution No. 345 of the Cabinet of Ministers of the Republic of Azerbaijan of 18 July 2024 approving the Rules for the State Registration of Medicines, Pharmaceutical Substances and Medical Devices, Their Entry in the State Register and the Maintenance of the State Register (in force from 19 July 2024; Xalq qəzeti No. 151 of 20 July 2024; Legislative Collection 2024, No. 7, Article 906; repealing Resolution No. 108 of 13 July 2007 with effect from 20 July 2024) (State registration, entry in the Register and Register maintenance rules).
• Decision No. 8 of the Collegium of the Ministry of Health of the Republic of Azerbaijan of 21 May 2024 on the Classification of Medical Devices by Risk Degree (adopted under the second sentence of Article 6.8 of the Law on Medicines; signed by Minister Teymur Musayev; to be sent to the Ministry of Justice for inclusion in the National Register of Legal Acts within 3 days of adoption), and Decision No. 7 of the Collegium of the Ministry of Health of the Republic of Azerbaijan of 21 May 2024 on the List of Higher, High and (or) Medium Risk Medical Devices (listing by device nomenclature code and level the items falling within the registration-required range) (classification and risk lists).
• Law of the Republic of Azerbaijan on Medicines (No. 208-IIIQ, adopted 22 December 2006, in force 28 February 2007, Legislative Collection 2007, No. 2, Article 70), as amended by Law No. 979-VIQD of 14 July 2023 (adding Articles 1-1 and 9-1 as new provisions, Legislative Collection 2023, No. 8, Article 1127) (Articles 1-1, 9-1, 6.1, 6.5, 6.11 and 6.12).
• Law of the Republic of Azerbaijan on Licenses and Permits (No. 176-VQ of 15 March 2016), Articles 18.2.1–18.2.3, 19.9, 25 and 26.1 (Articles 18.2.1 to 18.2.3 and 19.9).
• Resolution No. 502 of the Cabinet of Ministers of the Republic of Azerbaijan of 25 December 2019 approving the Rules for Conducting the Expertise of Medicines (Simplified) (Xalq qəzeti No. 290 of 28 December 2019; Legislative Collection 2019, No. 12, Article 2083; in force from 1 July 2020) (expertise implementation rules), Resolution No. 503 of 25 December 2019 on Pharmacovigilance Rules (vigilance), and Resolution No. 460 of 27 November 2019 on the Rules for the Withdrawal of Medicines (withdrawal).
• Resolution No. 140 of the Cabinet of Ministers of the Republic of Azerbaijan of 25 April 2025 (amending the Rules annexed to Resolution No. 345, harmonising the term registration certificate, qeydiyyat vəsiqəsi, into certificate, vəsiqə; Xalq qəzeti No. 86 of 30 April 2025; Legislative Collection 2025, No. 4, Volume II, Article 426) (terminology amendment of 25 April 2025).

3. Expert insights

Insight one: the outcome of an Azerbaijan project is decided, to a large extent, before submission. Of the 11 dossier items of Article 4.2, few require deep technical work, but three items determine whether the file is returned: the notarised translations, the entity qualification documents and the consistency of the risk degree. GRZAN treats these three as a fixed pre-submission checklist.

Insight two: the 7-working-day renewal window demands a resident service, not an on-call one. Article 7.8 allows only 7 working days, and Article 6.16 allows only 5 working days for fee payment. The local cooperation network of GRZAN in Azerbaijan handles document receipt and forwarding, compressing the response lag of the foreign manufacturer to a minimum.

Insight three: the local certificate holder arrangement is a long-term commitment, not a one-off act. The certificate holder field of the Annex 5 certificate requires a local legal entity, branch or representative office, or an individual entrepreneur with a tax identification number, and the correspondence under Articles 11.3 and 12.2 is served on the certificate holder. GRZAN writes the holder arrangement and the document-forwarding obligation into the contract, avoiding shell arrangements that hold the certificate without bearing responsibility.

Insight four: where criteria are uncertain, we replace guessing with written confirmation. For the many points marked pending verification or practical estimate in this series — the textual tension between Articles 1-1 and 9-1, the cross-references of Articles 9-1.11 and 6-2, the interpretation of the permissive language of Article 7.8, device fee rates, and the application of Articles 11.1.2 and 12.1.3 to devices — we obtain written confirmation from the AEC project by project and archive the replies, never relaying unconfirmed positions to clients.

4. Practical recommendations

1. Produce a legal sources and article mapping table at project launch, aligning every deliverable with a specific article number.
2. Complete the three fixed pre-submission checks: notarised translations, entity qualification documents and risk degree consistency.
3. Write the local certificate holder arrangement and the document-forwarding obligation into the contract together, with a 1-working-day forwarding deadline.
4. Build a compliance calendar anchored to the certificate issue date, with renewal, change and inspection nodes visible 12 months ahead.
5. Obtain written AEC confirmation item by item for every pending verification point and practical estimate, archiving the replies and sharing them with the client.
6. Review the regulations and rates sections of the AEC website each quarter, notifying clients of rule changes within 5 working days.

5. Verification checklist

• □ The legal sources and article mapping table has been issued.
• □ The three fixed pre-submission checks are complete (notarised translations, entity qualification, degree consistency).
• □ The certificate holder arrangement and the document-forwarding obligation are written into the contract.
• □ The compliance calendar has been built with 12-month visibility.
• □ All pending verification items have been confirmed in writing with the AEC and archived.
• □ The regulations and rates sections of the AEC website are on the quarterly review list.

• Article 11 — The full State registration process: application, expertise and issue in three stages: https://www.grzanglobal.com/azerbaijan-medical-device-registration/state-registration-full-process/
• Article 13 — The 11 dossier items broken down one by one: 4.2.1 to 4.2.11: https://www.grzanglobal.com/azerbaijan-medical-device-registration/dossier-11-items-breakdown/
• Article 31 — The 5-year validity: Article 6.11 of the Law and Article 8.1 of the Rules: https://www.grzanglobal.com/azerbaijan-medical-device-registration/five-year-validity-of-certificate/

Regulatory information verified as of October 30, 2026.

GRZAN supports manufacturers and authorised representatives preparing registration dossiers and post-market compliance documentation for the Azerbaijan market, from legal source mapping and pre-submission checks to local certificate holder arrangements and written AEC confirmations. For tailored assistance with your Azerbaijan medical device documentation, contact us at info@grzanglobal.com.