Azerbaijan Medical Device Registration: One Certificate per Device and the Treatment of Accessories

1. Key takeaways

Azerbaijan applies the principle of one certificate per device: certificates are issued per device (Annex 5 provides one certificate per device, and Annex 6 is the certificate for registered changes), and each certificate carries its own register number of the medical device. Paragraph 7.10 additionally provides that components (komplektləşdiricilər) that form part of the device and are not used independently are registered together with the device as a set — accessories of this kind do not receive separate certificates.

The Annex 5 certificate dedicates a dedicated field, Accessories (Komplektləşdiricilər), for this purpose, and paragraph 10.4.5 also lists accessories among the data fields recorded in the state register.

2. Legal basis

• Resolution of the Cabinet of Ministers of the Republic of Azerbaijan No. 345 of July 18, 2024, on the Rules for the National Registration of Medicinal Products, Pharmacologically Active Substances and Medical Devices, Their Inclusion in the State Register and the Maintenance of the State Register (entered into force on July 19, 2024; Xalq qəzeti, July 20, 2024, No. 151; Collection of Legislation, 2024, No. 7, Article 906; repealed Resolution No. 108 of July 13, 2007, with effect from July 20, 2024): paragraph 7.10 (components registered together with the set), paragraph 10.4.5 (accessories recorded in the register), paragraph 10.4 (seven data fields of the device register), Annex 5 (device certificate format, containing the Accessories field and the Register number field), Annex 6 (certificate format for registered changes), paragraph 2.1.4 (definition of components), paragraph 7.2 (change registration retains the registration number).
• Resolution of the Cabinet of Ministers of the Republic of Azerbaijan No. 345 of July 18, 2024 (same act): paragraph 6.10 (medicinal products are registered separately by dosage form and dosage, with separate certificates, cited for comparison), paragraph 6.7 (registered items are entered in the register under non-repeating numbers).
• Decision No. 8 of the Board of the Ministry of Health of the Republic of Azerbaijan of May 21, 2024, on the Classification of Medical Devices by Risk Level (adopted pursuant to 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 inclusion in the register of legal acts within 3 days of adoption): paragraph 2.1.10 (definition of accessories, ləvazimat), paragraph 3.8 (accessories are classified separately), paragraph 2.1.3 (certificate numbers are not repeated).

3. Expert insights

Insight 1: Paragraph 7.10 applies only to components that form part of the device and are not used independently. The wording covers components that form part of the device and are not used on their own. Accessories that can be used independently, for example probes or modules that can be sold separately, fall outside the scope of this provision — each of them is itself a device and must be registered and certified separately. The assessment rests on the definition of components in paragraph 2.1.4 and on the intended use of the product.

Insight 2: Components (komplektləşdirici) are registered with the set, whereas accessories (ləvazimat) are risk-classified separately. Paragraph 3.8 of Decision No. 8 provides that the risk class of an accessory is determined independently of the device to which it belongs, while paragraph 7.10 provides that components are registered with the set. The two concepts are two different words in Azerbaijani, but both are easily rendered as accessories in other languages. The internal glossary must fix the distinction, otherwise the Accessories field of the certificate will be filled in incorrectly.

Insight 3: Unlike medicinal products, devices have no splitting rule for separate registration by dosage form. Paragraph 6.10, which concerns medicinal products, requires that different dosage forms and dosages of the same active substance be registered separately, applied for separately and certified separately. Devices have no corresponding provision — the unit of differentiation for devices is the device itself. Whether a model variation constitutes a different device, however, is not elaborated in the Rules (practical estimate: judge by whether the GMDN code, the risk class and the main technical parameters coincide; written confirmation from the AEC is recommended).

Insight 4: Paragraph 7.2 preserves the registration number in change registration, which secures traceability of the certificate. In change registration a new certificate is issued, but the registration number is retained and the new certificate records the date of the registered change of national registration. Combined with paragraph 6.7, under which registered items are entered in the register under non-repeating numbers, this creates a stable product identity.

Insight 5: The register number of the medical device printed on the certificate is a public lookup key. Both Annex 5 and Annex 6 contain a Register number of the medical device field, and paragraph 10.7 requires register data to be published on the websites of the Ministry of Health and the AEC. This number is the main entry point for distributors and regulators verifying product identity, and it must remain consistent across all external product materials.

4. Practical recommendations

1. Assess each accompanying item by whether it can be used independently: components are registered with the set, while independently usable devices are registered separately.
2. Fix the distinction in the internal glossary: komplektləşdirici means a component registered with the set, ləvazimat means an accessory classified separately by risk.
3. Whether a model variation constitutes a different device should be judged by the GMDN code, the risk class and the main technical parameters, and confirmed in writing with the AEC.
4. Fill the Accessories field of the Annex 5 certificate only with components registered with the set, not with modules that can be sold separately.
5. Print the register number of the medical device consistently on all external product materials and verify it against the published register data.
6. In change registration, verify that the new certificate retains the original registration number and records the date of the change (paragraph 7.2).

5. Verification checklist

• □ The classification between components and independently usable devices has been completed on the basis of independent use.
• □ The internal glossary fixes the correspondence between the two accessory concepts.
• □ The registration treatment of model variations has been confirmed in writing with the AEC.
• □ The Accessories field of the certificate has been completed as required.
• □ The device register number has been harmonized across external materials and verified against the register.
• □ New certificates issued in change registration have been checked for retention of the original registration number.

Regulatory information verified as of October 30, 2026.

This article was prepared and translated by GRZAN as part of the international medical device registration guide. For professional support with regulatory submissions in Azerbaijan and other jurisdictions, contact info@grzanglobal.com.