Azerbaijan State Register of Medical Devices: The Seven Data Fields of Article 10.4

1. Key takeaways

Part 10 of Rules No. 345 provides that the State Register is maintained by the agency determined through the Ministry of Health (AEC) (Article 10.1). For medical devices, the Register records 7 data fields (Articles 10.4.1 to 10.4.7):

10.4.1 the trade name of the device;

10.4.2 the type of the device;

10.4.3 the risk degree;

10.4.4 the description of the primary and (or) secondary packaging;

10.4.5 the accessories;

10.4.6 the TVQN (GMDN) code;

10.4.7 where the device contains a pharmaceutical substance, information on the active ingredient and the dosage of that substance.

Article 10.5 provides that the certificate, the description of the primary or secondary packaging, and the instructions for use are uploaded to the Register in electronic format. Article 10.7 provides that the Register data are compiled in electronic form and published on the official websites of the Ministry of Health and the AEC.

Taken together, these provisions make the State Register a public profile of every registered device. The trade name, the type, the risk degree, the accessories and the GMDN code appear both on the certificate and in the Register, so the same seven fields can be checked against the physical product before submission, and any inconsistency is visible to distributors, tender committees and competitors.

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): Article 10.1 (the Register is maintained by the agency determined through the Ministry of Health), Articles 10.4.1 to 10.4.7 (the 7 device fields), Article 10.5 (electronic upload of the certificate, the packaging description and the instructions for use), Article 10.6 (entries on revocation, expiry and suspension), Article 10.7 (publication on the official websites of the Ministry of Health and the agency), Article 2.1.3 (non-repeating certificate number), Article 13.1 (confidentiality of information).
• 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): Article 6.7 (registered items enter the Register under a non-repeating number), Article 1.0.5-1 (definition of the State Register), Article 1-1 (list of provisions applicable to devices).
• 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): Article 3.2 (one device falls into one degree only), Article 3.3 (four degrees).

3. Expert insights

Insight one: the 7 fields overlap heavily with the certificate fields of Annex 5, creating a dual publication of certificate and Register. The trade name, the type, the risk degree, the accessories and the GMDN code all appear in both places. This means that one error entered once is wrong in two public places. Building a checklist from these 7 items before submission is the most cost-effective compliance action available, because it catches discrepancies while they are still correctable on paper rather than after publication.

Insight two: Article 10.4.7 brings the formulation of drug-containing devices into public view. Where a device contains a pharmaceutical substance, the Register must record the active ingredient and the dosage of that substance. This creates a tension with the confidentiality obligation of Article 13.1: Article 13.1 protects submitted information, while Article 10.4.7 requires publication of a Register field. Confidential information should be asserted as such at the time of submission, with the scope clearly identified; do not assume blanket confidentiality by default, because the rule itself carves out the Register fields.

Insight three: Article 10.6 makes status changes part of the public record. Where State registration is revoked, the fact and the date of revocation are recorded; where validity expires, the fact and the date of expiry are recorded with the corresponding entry under Article 6.12 of the Law on Medicines; where registration is suspended, the fact and the date of suspension are recorded. The compliance status of a company is therefore publicly searchable, which has a direct impact on tender eligibility and on channel partnerships.

Insight four: the electronic upload under Article 10.5 makes the instructions for use and the packaging part of the Register itself. The certificate, the description of the primary or secondary packaging and the instructions for use are uploaded in electronic format. Read together with Article 9.2 (confirmed instructions for use published as PDF on the AEC website), the external documentation set of a device is a triad of certificate fields, packaging description and instructions for use, all electronic and downloadable by anyone.

Insight five: Articles 2.1.3 and 6.7 together guarantee the uniqueness of the number. Article 2.1.3 defines the certificate number as a non-repeating number assigned at registration, and Article 6.7 of the Law on Medicines likewise requires entry under a non-repeating number. This number is the stable identity of the product across its whole lifecycle and is retained in change registration (Article 7.2).

4. Practical recommendations

1. Use the 7 fields of Article 10.4 to build a public profile checklist, and verify each item against the physical labels, packaging and instructions for use before submission.
2. File confidential pharmaceutical substance information as a separate volume, and cite Article 13.1 in the cover letter with the scope of confidentiality clearly specified.
3. Set up a quarterly self-check comparing the published Register fields with the current physical product and the certificate; where they diverge, follow the change route of Article 1.5.
4. Keep the certificate number as the stable identifier of the product across its lifecycle and print it uniformly on all external materials.
5. Monitor status entries in the Register (revocation, expiry, suspension) and brief channel partners in writing within 48 hours of any such entry.
6. Download and archive the instructions-for-use PDF published on the AEC website and reconcile it against the internally confirmed version.

5. Verification checklist

• □ The public profile checklist based on the 7 fields of Article 10.4 has been built.
• □ Confidential pharmaceutical substance information has been filed separately with Article 13.1 invoked.
• □ A quarterly self-check of the published Register fields has been scheduled.
• □ The certificate number is printed uniformly on all external materials.
• □ A 48-hour response mechanism for Register status changes is in place.
• □ The instructions-for-use PDF published by the AEC has been archived and reconciled.

• Article 10 — The State Register of Azerbaijan: the seven data fields for devices: https://www.grzanglobal.com/azerbaijan-medical-device-registration/gmdn-code-mandatory-field/
• Article 23 — Brief description: scope, purpose and accessory composition: https://www.grzanglobal.com/azerbaijan-medical-device-registration/brief-description-scope-purpose-accessories/
• Article 42 — Suspension of State registration: 4 grounds and a full stop on import, sale and use: https://www.grzanglobal.com/azerbaijan-medical-device-registration/suspension-of-state-registration/

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 State Register field mapping and certificate data alignment to confidentiality filings and change registration. For tailored assistance with your Azerbaijan medical device documentation, contact us at info@grzanglobal.com.