Azerbaijan Medical Device Legal Definition: Article 1.0.1 Equivalence Explained

1. Key takeaways

Azerbaijani law does not provide a standalone definition of a medical device. Instead it uses an equivalence technique: Article 1.0.1 of the Law on Medicinal Products provides that medical devices used for the purposes of diagnosis, prevention and treatment of diseases, including devices, articles, objects and materials, instruments, equipment, medical reagents and optical appliances, are treated as medicinal products for the purposes of that law. The genuinely operational definitions are scattered across section 2.1 of Decision No. 8 of the Ministry of Health, which lists 11 terms including invasive, non-invasive, in vitro, IVD, sample container, active device, active therapeutic device, accessory and implantable device.

Determining whether a product is a device therefore takes two steps: first check whether it is covered by the purpose and category wording of Article 1.0.1, then check whether the terms in section 2.1 of Decision No. 8 can be mapped onto the specific product. Articles 1.0.13 and 1.0.14 add two definitions that are often overlooked: device certificate, a document certifying conformity with the requirements of the relevant technical regulatory legal acts, and device quality, meaning conformity with the technical regulatory legal acts and with the documents issued by the manufacturer on that basis.

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): Article 1.0.1 (the purpose and category wording under which devices are treated as medicinal products), Article 1.0.8 (definition of state registration as a system of measures), Article 1.0.13 (device certificate), Article 1.0.14 (device quality), Article 1-1 (the list of applicable and excluded provisions for devices and drug substances).
• 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): Articles 2.1.1 to 2.1.11 (analyte, risk degree, invasive, non-invasive, in vitro, IVD, sample container, active device, active therapeutic device, accessory, implantable device).
• 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 1.2.3 (the scope of devices subject to registration).

3. Expert insights

Insight 1: the equivalence with medicinal products is a double-edged sword. It allows devices to inherit a mature regulatory skeleton built for medicines, including registration, the register, vigilance and withdrawal, but it also means that a large number of medicinal product provisions are applied to devices directly. Article 1-1 exists precisely to prune that inheritance: it lists a long series of provisions that do not apply to devices, including the second sentence of Article 6.1 and Articles 6.2, 6.3, 6.9, 6.13, 6-1 and 6-2. Reading Article 1-1 carefully is the only way to know which medicinal product rules must not be applied.

Insight 2: there is a textual tension between Article 1-1 and Article 9-1. The exclusion list in Article 1-1 includes Article 9-1, yet subparagraphs 9-1.9 and 9-1.10 of Article 9-1 are precisely the document requirements targeted at device imports and imports of second-hand devices, and the AEC official website also cites Articles 9-1.7 and 9-1.8 on its temporary import page to explain device exhibition samples. Both articles were added by the same Law No. 979-VIQD. The approach adopted by GRZAN is to follow subparagraph 9-1.9 and the practical estimate published by AEC in execution, while simultaneously confirming this textual conflict with AEC in writing and retaining the reply, and never treating it as a basis for self-granted exemption.

Insight 3: Article 2.1.10 lists accessories as a separate term, and Article 3.8 provides that the risk degree of an accessory is determined independently. This forms a pair with Article 7.10 of the Resolution No. 345 Rules, under which accessories are registered as part of the set: the accessory gets its own classification, but at registration it is registered together with the main device and no separate certificate is issued. Classification and registration follow two different logics.

Insight 4: IVDs are fully embraced within the device category. Article 2.1.6 gives a complete IVD definition covering reagents, reagent products, calibrators, control materials, kits, instruments, apparatus, equipment or software systems, and Article 2.1.7 even brings sample containers within scope. This echoes Article 4.3 of the Resolution No. 345 Rules, which excludes devices used to examine human samples in test tubes in order to obtain information from the application of Article 4.2.5 on drug substance information.

4. Practical recommendations

1. When determining whether a product is a device, first perform the purpose and category comparison under Article 1.0.1, then map the terms of section 2.1 of Decision No. 8, and keep written records of both steps.
2. For software products, cite directly the software system wording in the IVD definition of Article 2.1.6 together with the software classification rules in Articles 6.10 to 6.14 of Decision No. 8.
3. For provisions listed in the Article 1-1 exclusion list, such as Article 6.13 on packaging languages, do not assume they apply to devices; confirm each item before it enters the dossier.
4. For accessory products do two things at once: classify them independently under Article 3.8, and register them as a set with the main device under Article 7.10.
5. On the conflict between Article 1-1 and Article 9-1, submit a written inquiry to AEC and file the reply in the project record; do not interpret it on your own.
6. Fix in the internal glossary the correspondence between the three terms device (tibb vasitələri), accessory (ləvazimat) and component (komplektləşdiricilər), to prevent mismatches between dossier fields and certificate fields.

5. Verification checklist

• □ The purpose comparison under Article 1.0.1 (diagnosis, prevention, treatment) has been completed and filed.
• □ The applicable terms from section 2.1 of Decision No. 8 have been selected for the product.
• □ The exclusion list of Article 1-1 has been checked item by item, and the medicinal product provisions that do not apply have been identified.
• □ A written inquiry on the conflict between Article 1-1 and Article 9-1 has been submitted to AEC.
• □ Accessory products have been classified independently under Article 3.8.
• □ The internal glossary fixes the correspondence between the terms device, accessory and component.

Related reading

• Article 01. Who Regulates Medical Devices in Azerbaijan: the Ministry of Health Issues Certificates and AEC Performs Expertise: https://www.grzanglobal.com/azerbaijan-medical-device-registration/who-regulates-medical-devices-in-azerbaijan/
• Article 04. How to Read Resolution No. 345: a Structural Guide to 13 Parts: https://www.grzanglobal.com/azerbaijan-medical-device-registration/resolution-345-rules-structure-guide/
• Article 17. Differentiated Requirements for IVDs: Section 7 of the Classification and the Exemption Provisions: https://www.grzanglobal.com/azerbaijan-medical-device-registration/ivd-specific-requirements/

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.