Azerbaijan Medical Device GMDN Code: Mandatory Register and Certificate Fields

1. Key takeaways

Azerbaijan requires the GMDN code, written in the Rules as TVQN kodu, meaning the Global Medical Device Nomenclature, in three places: a register field (Article 10.4.6), a device certificate field (Annex 5) and a device change certificate field (Annex 6). Article 2.1.2 of the Rules defines TVQN as the international code and terminology system adopted for the identification of medical devices. This is not an option; it is a format field.

There is a gap here that is easy to overlook: the GMDN code appears on the register and the certificate, yet the 11-item dossier list of Article 4.2 does not list the GMDN code separately. The code is therefore not one of the submitted documents but a register field derived from the application information, and its correctness depends on the description of the device type and risk degree given in the application form.

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 2024, No. 7, item 906; repealing Resolution No. 108 of July 13, 2007 with effect from July 20, 2024): Article 2.1.2 (definition of TVQN), Article 10.4.6 (the register must record the TVQN code), Article 10.4 (the 7 register fields for devices), Annex 5 (device certificate with the TVQN kodu field), Annex 6 (change certificate with the TVQN kodu field), Article 10.7 (register data published on the official websites of the Ministry of Health and AEC).
• 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): Article 2.1.2 (definition of risk degree), Article 3.2 (one device, one degree), Article 7.1 (certificate issuance).

3. Expert insights

Insight 1: the GMDN code is the interface of the Azerbaijani three-stage management chain of nomenclature, classification and registration. The list approved by Decision No. 7 of the Ministry of Health is itself organized by device nomenclature code (TİBB VASİTƏSİNİN NOMENKLATURA KODU), while the Resolution No. 345 Rules use the GMDN code as the identification field of the register and the certificate. Two coding systems run in parallel: the list uses the Ministry nomenclature hierarchy codes and the certificate uses GMDN. In practice both codes must be prepared, and the position of the product on the Decision No. 7 list must be confirmed.

Insight 2: a misassigned code means a mismatch between certificate and goods, and it is publicly verifiable. Article 10.7 requires register data to be published on the official websites of the Ministry of Health and AEC, and the certificate itself carries the GMDN code. If the code of a product does not match its actual category, any purchaser, competitor or regulator can detect the mismatch through the public register, and it may trigger Article 5.1.4, under which inconsistencies related to quality, efficacy or safety are found in the submitted documents.

Insight 3: the 7 fields of Article 10.4 form the public profile of a device. Besides the GMDN code they include: trade name (10.4.1), device type (10.4.2), risk degree (10.4.3), description of the primary and (or) secondary packaging (10.4.4), components (10.4.5), and where drug substances are present, the active ingredients and dosage information (10.4.7). These 7 fields overlap heavily with the Annex 5 certificate fields, so an error in one place is wrong in two places at once.

Insight 4: Article 10.5 brings the certificate, packaging descriptions and instructions for use into an electronic register. The certificate, the description of the primary or secondary packaging and the instructions for use are uploaded to the register in electronic format. Together with the GMDN code, these electronic documents form a product file open to public inspection, and post-market consistency maintenance, as discussed in Article 45 of this series, is precisely the maintenance of the consistency of this file.

4. Practical recommendations

1. Complete the GMDN code search before submission and record the code version and the search date, cross-checking against the device type description in the application form.
2. Confirm in parallel the coding level of the product on the nomenclature list of Decision No. 7 of the Ministry of Health, and archive both codes together.
3. Use the 7 fields of Article 10.4 to build a public profile check sheet, and compare each item against the physical labels, packaging and instructions for use before submission.
4. Map one SKU to one GMDN code; where a set is registered as a whole under Article 7.10, enter the code of the main device and note the components in the components field.
5. After the register entry becomes public, self-check the 7 fields once per quarter, and where deviations are found run a change state registration under Article 1.5.
6. Retain written records of the code search and the classification statement as the basis for later audits or disputes.

5. Verification checklist

• □ The GMDN code search has been completed and the code version and search date recorded.
• □ The coding level of the product on the nomenclature list of Decision No. 7 has been confirmed.
• □ The public profile check sheet has been completed against the 7 fields of Article 10.4.
• □ The certificate fields and the register fields have been checked for consistency, including the GMDN code and the risk degree.
• □ The code entry rule for sets has been confirmed (code of the main device plus the components field).
• □ A quarterly self-check reminder for the public register fields has been set.

Related reading

• Article 21. The Application Form (Annex 1): Completion Points and the Criminal Liability Declaration: https://www.grzanglobal.com/azerbaijan-medical-device-registration/application-form-annex-1/
• Article 23. The Brief Description: Scope of Application, Intended Use and Component Composition: https://www.grzanglobal.com/azerbaijan-medical-device-registration/brief-description-scope-purpose-accessories/
• Article 41. The State Register: the 7 Registered Fields for Devices: https://www.grzanglobal.com/azerbaijan-medical-device-registration/state-register-seven-data-fields/

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.