Azerbaijan Medical Device Registration 2026: Brief Description – Scope, Purpose and Accessories

1. Key takeaways

Article 4.2.3 requires a brief description of the device issued by the manufacturer, covering three things: the fields of application (tətbiq sahələri), the purpose (təyinatı) and the set of accessories (komplektləşdiricisi). Together with the labelling and packaging information under Article 4.2.4 and the declaration of conformity under Article 4.2.8, this item forms the trio of manufacturer self-descriptions in the dossier.

Article 2.1.4 defines accessories (komplektləşdiricilər) as items that are neither the device itself nor device equipment, including units, parts, elements, materials and spare parts that the device manufacturer intends to form part of the device or to be used together with it. Article 10.4.5 lists accessories among the register entries, and the Annex 5 certificate also has a field headed Accessories (Komplektləşdiricilər). The brief description therefore feeds directly into fields that are published in the state register and printed on the registration certificate.

2. Legal basis

• Resolution No. 345 of the Cabinet of Ministers of the Republic of Azerbaijan of July 18, 2024 on the Rules for the State Registration of Medicinal Products, Drug Substances and Medical Devices, Their Entry in the State Register and the Maintenance of the State Register (effective July 19, 2024; Xalq qəzeti No. 151 of July 20, 2024; Legislative Compilation 2024, No. 7, item 906; repealing Resolution No. 108 of July 13, 2007 as of July 20, 2024): Article 4.2.3 (three contents of the brief description), Article 2.1.4 (definition of accessories), Article 10.4.5 (accessories entered in the register), Annex 5 (certificate carries an Accessories field), Article 7.10 (accessories registered together with the complete set), Article 5.1.4 (inconsistent documents are a ground for rejection).
• 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 within 3 days of adoption for entry in the register of legal acts): Article 2.1.10 (definition of equipment, ləvazimat, and its separate classification under Article 3.8).
• 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 within 3 days of adoption for entry in the register of legal acts): Articles 3.1.1 to 3.1.8 (classification dimensions, directly related to the description of the fields of application).

3. Expert insights

Insight 1: The fields of application in the brief description directly determine the classification outcome. Among the eight classification dimensions in Article 3.1 of Decision No. 8, contact with tissues or organs (3.1.5), the route of administration (3.1.6) and whether vital organs are affected (3.1.7) all derive from the description of the fields of application and the purpose. If the description is written one notch too broad, the risk degree may rise by one class; if it is written one notch too narrow, the device may later be found to exceed the scope of its certificate on the market. Writing a fields-of-application statement that is just sufficient is the core technique for this item.

Insight 2: Article 2.1.4 separates accessories (komplektləşdirici) from the equipment (ləvazimat) defined in Article 2.1.10. Accessories are units, parts, elements, materials and spare parts that the manufacturer intends as part of the device or for use together with it; equipment is a product that is not itself a device but that the manufacturer intends for use with a device for its intended purpose, or that directly supports the function of one or more devices. Article 7.10 only states that accessories are registered with the complete set, and Article 3.8 only states that the risk degree of equipment is determined separately. The two terms are distinct in Azerbaijani but are very easily mixed up in working documents, so it is advisable to fix them in an internal glossary: komplektləşdirici means accessories registered with the complete set, and ləvazimat means equipment classified separately.

Insight 3: The brief description flows into three public locations. Article 10.4.2 (device type), Article 10.4.5 (accessories) and the Accessories field of the Annex 5 certificate. It is both a dossier document and the source of published fields. Any content that cannot be maintained over the long term, such as a specific accessory model, will require a change of state registration under Article 1.5 whenever it is later modified, so the description should be drafted with its full life cycle in mind.

Insight 4: This item has no exemption. Article 4.3 exempts 4.2.1, 4.2.2, 4.2.8 and 4.2.9 for local production, 4.2.5 for in vitro diagnostic devices and 4.2.6 for devices that do not contact the human body, but it does not exempt 4.2.3. Whether the device is produced locally or imported, and whether it is an IVD or an ordinary device, the brief description must always be submitted.

4. Practical recommendations

1. Draft the brief description in three sections covering the fields of application, the purpose and the set of accessories, keeping each section within one page and avoiding descriptions so broad that the risk degree rises.
2. Fix the internal glossary: komplektləşdirici means accessories registered with the complete set, and ləvazimat means equipment classified separately.
3. List in the accessories only the items that ship with the main device, and exclude optional items, in order to reduce the future scope of change filings.
4. Keep the fields of application in the brief description consistent with the declaration of conformity under 4.2.8 and with the labelling and packaging under 4.2.4.
5. Check the brief description against the register fields under Articles 10.4.2 and 10.4.5 and against the Accessories field of the Annex 5 certificate.
6. For products with multiple SKUs, issue a separate brief description for each model rather than covering the whole range with one description.

5. Verification checklist

• □ The brief description has been drafted in three sections covering the fields of application, the purpose and the set of accessories.
• □ The fields of application do not exceed what is necessary and do not push the risk degree upward.
• □ The internal glossary has fixed the correspondence between accessories and equipment.
• □ The accessories list contains only items that ship with the main device.
• □ The description has been checked for consistency with the statements under 4.2.8 and 4.2.4.
• □ The register fields under 10.4.2 and 10.4.5 and the Accessories field of the certificate have been checked for consistency.

Related reading: Manufacturer Production Right Document and Annexes (https://www.grzanglobal.com/azerbaijan-medical-device-registration/manufacturer-production-right-document/); Labelling and Packaging: Azerbaijani Colour Mock-ups (https://www.grzanglobal.com/azerbaijan-medical-device-registration/labelling-and-packaging-azerbaijani-mockups/); Declaration of Conformity with Safety and Effectiveness Requirements and the Risk Degree (https://www.grzanglobal.com/azerbaijan-medical-device-registration/safety-effectiveness-declaration-risk-level/).

GRZAN provides regulatory consulting for medical device manufacturers and exporters, covering Azerbaijan state registration dossiers, device descriptions, risk classification and register field management. For tailored support on this topic, contact GRZAN at info@grzanglobal.com.

Regulatory information verified as of October 30, 2026.