Azerbaijan Medical Device Registration 2026: Declaration of Conformity with Safety and Effectiveness Requirements and Risk Degree

1. Key takeaways

Article 4.2.8 requires a declaration by the manufacturer of conformity with the safety and effectiveness requirements for the production of the device, stating the risk degree. The three elements of this clause are: it is issued by the manufacturer, it addresses the safety and effectiveness requirements for production, and it states the risk degree. Article 4.3 provides that this item does not apply to devices manufactured within the territory of Azerbaijan.

Read together with Article 1.0.14 of the Law on Medicinal Products: the quality of a device is the condition of the device conforming to the relevant technical regulatory legal documents, and to the documents issued by the manufacturer on the basis of those requirements. The declaration of conformity is precisely the core of the documents issued by the manufacturer on that basis, and it anchors the quality definition in a concrete, signed statement.

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 4.2.8 (three elements of the declaration of conformity), Article 4.3 (exemption for local production), Article 5.1.4 (inconsistent documents are a ground for rejection), Article 10.4.3 (risk degree entered in the register), Annex 5 (certificate carries a Risk degree field).
• Law of the Republic of Azerbaijan on Medicinal Products (Dərman vasitələri haqqında), No. 208-IIIQ, adopted December 22, 2006, effective February 28, 2007, Legislative Compilation 2007, No. 2, item 70, as amended by Law No. 979-VIQD of July 14, 2023 (adding Articles 1-1 and 9-1 with new wording, Legislative Compilation 2023, No. 8, item 1127): Article 1.0.14 (definition of the quality of a device), Article 1.0.13 (definition of a device certificate).
• 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 3.2 (one device belongs to only one degree), Article 3.3 (degree 4), Article 3.4 (scope of registration).

3. Expert insights

Insight 1: The risk degree is stated in the declaration of the manufacturer itself, which shifts part of the classification responsibility to the manufacturer. Article 4.2.8 requires the declaration to state the risk degree given by the manufacturer, while the classification competence under Decision No. 8 lies with the body determined by the Ministry of Health. Where the two do not match, Article 5.1.4, on inconsistencies related to quality, effectiveness or safety found in the submitted documents, becomes a ground for rejection. A manufacturer cannot rely on not knowing how the local classification works to escape this responsibility, so the degree must be checked against the classification dimensions before filing.

Insight 2: The exemption of Article 4.3 for local production rests on the logic that a self-declaration has no further purpose. Devices manufactured within Azerbaijan are exempt from four items: 4.2.1 (manufacturing right), 4.2.2 (foreign registration), 4.2.8 (declaration of conformity) and 4.2.9 (QMS certificate). The reasonable inference is that domestic production is already subject to the national production regulatory system, so the foreign chain of proof built on manufacturing right, foreign market authorisation, self-declaration and QMS is no longer necessary. But local production does not exempt 4.2.3, 4.2.4, 4.2.6, 4.2.7, 4.2.10 or 4.2.11 (pending verification: whether 4.2.5 applies depends on whether the product contains a medicinal substance).

Insight 3: The risk degree in the declaration flows into two public locations. Article 10.4.3 (risk degree entered in the register) and the Annex 5 certificate (Risk degree of medical device). Once the declaration is filed and accepted, the degree becomes public; to change it, a change of state registration must be filed under Article 1.5. Any correction of a degree that was stated too low therefore carries both a compliance cost and a public record.

Insight 4: Article 1.0.13 defines a device certificate, which is a different thing from the declaration of conformity. Article 1.0.13 defines a device certificate as a document certifying that the device conforms to the requirements of the relevant technical regulatory legal documents. That definition is closer to a conformity assessment certificate, whereas Article 4.2.8 is a self-declaration by the manufacturer. Both may be called certificates in loose usage, and they should be clearly distinguished in working documents to avoid mixing them up in the dossier.

4. Practical recommendations

1. Issue the declaration of conformity on the letterhead of the manufacturer, expressly stating that it is issued by the manufacturer, that the device conforms to the safety and effectiveness requirements for production, and that the risk degree is the stated class.
2. Check the risk degree in the declaration word for word against the classification rationale document, Article 10.4.3, and the Annex 5 certificate, so that all four locations are identical.
3. Have the declaration signed by a person authorised to sign for the manufacturer, with the date of signature and, where applicable, the period of validity noted.
4. In local production cases, invoke the exemption of Article 4.3 for item 4.2.8 in the covering letter.
5. Distinguish in the internal glossary between the declaration of conformity (4.2.8) and the device certificate (Article 1.0.13), and do not mix them.
6. File changes of the risk degree as a change of state registration under Article 1.5, and never replace the declaration unilaterally.

5. Verification checklist

• □ The declaration of conformity has been issued on the letterhead of the manufacturer and contains the three required elements.
• □ The risk degree in the declaration has been checked against the classification rationale document, 10.4.3 and Annex 5.
• □ The declaration has been signed by a person authorised to sign and is dated.
• □ In local production cases, the exemption under Article 4.3 has been invoked in the covering letter.
• □ The internal glossary distinguishes the declaration of conformity from the device certificate.
• □ Changes of the risk degree have been brought under change management procedures.

Related reading: Brief Description: Scope, Purpose and Accessories (https://www.grzanglobal.com/azerbaijan-medical-device-registration/brief-description-scope-purpose-accessories/); Biosafety Information: When It Can Be Omitted (https://www.grzanglobal.com/azerbaijan-medical-device-registration/biosafety-information-exemptions/); Four Risk Degrees: Low, Medium, High and Highest (Classes 1, 2a, 2b and 3) (https://www.grzanglobal.com/azerbaijan-medical-device-registration/four-risk-degrees-class-1-2a-2b-3/).

GRZAN provides regulatory consulting for medical device manufacturers and exporters, covering Azerbaijan state registration dossiers, declarations of conformity, 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.