Azerbaijan Medical Device Regulation 2023–2024: From Law No. 979-VIQD to Resolution No. 345

1. Key takeaways

Mandatory device registration in Azerbaijan did not always exist. The real turning point was Law No. 979-VIQD of July 14, 2023, which added Articles 1-1 and 9-1 to the Law on Medicinal Products as new provisions, rewriting the scope of the equivalence of devices with drug substances and the import permit regime. It was followed by Resolution No. 345 of July 18, 2024, which approved the new state registration rules, entered into force the next day, and repealed Resolution No. 108 of 2007 with effect from July 20, 2024. The complete chain through which the system landed is: legislative amendment, presidential decree assignment, Cabinet rules, and then Ministry of Health classification and lists.

Law No. 979-VIQD was published on August 15 and 16, 2023 in AZƏRTAC and in the newspaper Azərbaycan No. 173 respectively, and recorded in the Legislative Collection 2023, No. 8, item 1127. The legal basis section of Resolution No. 345 cites this law directly, together with item 2.2.3 of Presidential Decree No. 2298 of August 15, 2023.

2. Legal basis

• 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) (Articles 1-1 and 9-1 were added by that law as new provisions).
• 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 2024, No. 7, item 906; repealing Resolution No. 108 of July 13, 2007 with effect from July 20, 2024) (its legal basis includes the first sentence of Article 6.8 of the Law on Medicinal Products).
• Presidential Decree No. 2298 of the Republic of Azerbaijan of August 15, 2023 (amending Decree No. 528 of February 6, 2007; items 2.2.3, 3.1.1 and 3.1.3) (item 2.2.3 contains the assignment of tasks).
• Decision No. 8 of the Collegium of the Ministry of Health of the Republic of Azerbaijan of May 21, 2024, on the Classification of Medical Devices by Risk Degree (adopted under the second sentence of Article 6.8 of the Law on Medicinal Products; signed by Minister Teymur Musayev; sent to the Ministry of Justice for entry into 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 May 21, 2024, on the List of Higher, High and (or) Medium Risk Medical Devices (listing by device nomenclature code and hierarchy the products falling within the registration scope) (Decision No. 8 cites item 3.1.3 of Decree No. 2298, Decision No. 7 cites item 3.1.1).
• Article 14.5 and Article 17-1 of the Charter of the Ministry of Health annexed to Presidential Decree No. 413 of the Republic of Azerbaijan of May 25, 2006 (Article 17-1 and item 14.5 are the source of authority for decisions of the Collegium of the Ministry of Health).

3. Expert insights

Insight 1: there is a one-year gap between the legislative amendment and the implementing rules, and compliance status during this window is the easiest thing to misjudge. The law was adopted in July 2023, but the rules only came into force in July 2024. For the period in between, the answer to the question of whether registration is required is that the law had already authorized registration, but the operational dossier rules had not yet taken shape. The value of reviewing this history is that the Azerbaijani device system is still in a formative stage, and any dated secondary material may already be obsolete.

Insight 2: the repeal date of Resolution No. 108 and the entry into force date of the new Rules are not the same day. Resolution No. 345 entered into force on July 19, 2024, but its Article 2 provides that Resolution No. 108 is repealed from July 20, 2024. This staggered design, with entry into force and repeal offset by one day, avoids a vacuum or overlap between the old and new rules on the same day.

Insight 3: the numbering of the two Ministry of Health decisions is mirrored in an unexpected way. On May 21, 2024, the Collegium adopted two decisions on the same day: Decision No. 7 approved the list of higher, high and (or) medium risk devices, and Decision No. 8 approved the classification of devices by risk degree. The numbering runs counter to intuition: the list came first (No. 7) and the classification came second (No. 8), and the two decisions cite different items of the presidential decree (3.1.1 and 3.1.3). Secondary sources variously record these numbers as No. 8 and No. 9, or as No. 7 and No. 8; this series follows the official texts.

Insight 4: the Rules themselves have already been amended once in 2025. Resolution No. 140 of the Cabinet of Ministers of April 25, 2025 replaced the term registration certificate (qeydiyyat vəsiqəsi) in the Rules with certificate (vəsiqə) throughout, and removed the word REGISTRATION from the annex titles. This was a purely terminological adjustment, but it shows that the rules are still under dynamic maintenance, so any citation must carry the version.

4. Practical recommendations

1. When citing the Resolution No. 345 Rules, always indicate as amended by Resolution No. 140 of April 25, 2025, to avoid confusion with the original 2024 version.
2. When citing the Ministry of Health decisions, always write the full reference, Decision No. 7 or No. 8 of May 21, 2024, and do not rely on the numbering used in secondary sources.
3. When assessing the compliance status of historical projects between July 2023 and July 2024, treat them as authorized by law but without operative rules, and confirm in writing with AEC.
4. Maintain a regulatory version ledger with three columns for laws, Cabinet resolutions and Ministry of Health decisions, recording for each the adoption date, publication date and effective date.
5. Base all external quotations and schedules on the current rules, and do not carry over benchmarks from before 2024.
6. Review the regulatory section of the AEC official website once per quarter to confirm whether new decisions or announcements have been issued.

5. Verification checklist

• □ The ledger records the adoption date of Law No. 979-VIQD (2023-07-14) and its publication channels.
• □ The ledger records the adoption date of Resolution No. 345 (2024-07-18), its effective date (2024-07-19) and the date of repeal of Resolution No. 108 (2024-07-20).
• □ The ledger records the terminological amendments made by Resolution No. 140 (2025-04-25).
• □ The correct numbers and dates of Ministry of Health Decision No. 7 (list) and Decision No. 8 (classification) have been confirmed.
• □ Historical internal materials have been screened for any residual benchmarks dating from the era of Resolution No. 108.
• □ A quarterly reminder to review the regulatory section of the AEC official website has been set.

Related reading

• Article 03. The Legal Definition of a Medical Device: the Equivalence Wording of Article 1.0.1 of the Law on Medicinal Products: https://www.grzanglobal.com/azerbaijan-medical-device-registration/legal-definition-of-medical-device/
• Article 05. Four Risk Degrees: Low, Medium, High and Higher (Classes 1, 2a, 2b and 3): https://www.grzanglobal.com/azerbaijan-medical-device-registration/four-risk-degrees-class-1-2a-2b-3/
• Article 49. The Azerbaijan Compliance Calendar for the Next 12 Months: https://www.grzanglobal.com/azerbaijan-medical-device-registration/azerbaijan-compliance-calendar-next-12-months/

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.