Azerbaijan Medical Device Registration 2026: Quality Management System Certificate and the Local Production Exemption

1. Key takeaways

Article 4.2.9 requires a copy of the certificate of the quality management system for the manufacture of the device issued by the manufacturer. Article 4.3 provides that this item does not apply to devices manufactured within the territory of Azerbaijan.

The Rules themselves do not name a system standard. In practice, foreign manufacturers usually submit an ISO 13485 certificate (practical estimate: the Rules do not name a standard; follow the requirements of the AEC). Together with the proof of the manufacturing right under Article 4.2.1 and the declaration of conformity under Article 4.2.8, this item forms a triple proof of the capability of the manufacturer, covering the right to produce, the declared conformity and the management system behind both.

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 4.2.9 (QMS certificate), Article 4.2.1 (proof of the manufacturing right), Article 4.2.8 (declaration of conformity), Article 4.3 (local production exempts 4.2.1, 4.2.2, 4.2.8 and 4.2.9), Article 5.1.4 (inconsistent documents are a ground for rejection), Article 8.1 (certificate valid for 5 years).
• 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 1-1 (list of articles applicable to devices).
• Notice on Information Related to the State Registration of Medical Devices, published on July 19, 2024 and effective from July 22, 2024, by the Analytical Expertise Center of the Ministry of Health of Azerbaijan (AEC / Analitik Ekspertiza Mərkəzi), published on the AEC website pharma.az (the AEC website publishes the dossier requirements, against which the current acceptance practice can be checked).

3. Expert insights

Insight 1: The validity period of the QMS certificate is not synchronised with the 5-year validity of the registration certificate, which is a hidden renewal risk. The certificate is valid for 5 years (Article 8.1), while an ISO 13485 certificate is usually valid for 3 years and must be maintained through surveillance audits. If the QMS certificate expires or is suspended during the validity period of the registration certificate, it affects the completeness of the documents at re-registration (Article 7.8). A reminder set six months before the expiry of the QMS certificate is recommended, so that renewal and surveillance audits are completed before the dossier is reopened.

Insight 2: The scope of the QMS certificate must cover the product applied for registration. The certificate usually states the covered product categories and sites. If the product applied for is outside the scope, or the manufacturing address differs from the address on the certificate, the inconsistency under Article 5.1.4 may be triggered. The scope must be checked together with the coverage of the proof of the manufacturing right under Article 4.2.1, since both documents describe the same manufacturing reality from different angles.

Insight 3: The exemption of Article 4.3 for local production is the most valuable of the four exempted items. Local production exempts 4.2.1, 4.2.2, 4.2.8 and 4.2.9 in one step, which is more than a third of the eleven-item dossier. For companies considering establishing local manufacturing in Azerbaijan, this is a real and measurable difference in document cost. But local production also brings local regulatory requirements for the production stage, so the calculation must not stop at the document savings.

Insight 4: The Rules do not name a system standard, which leaves discretion to the AEC. Article 4.2.9 speaks only of a quality management system certificate, without mentioning ISO 13485. This means that if a manufacturer holds proof of a system established under a different regulatory regime, such as system documentation under the United States QSR 21 CFR 820 or a national GMP certificate, whether it is accepted must be confirmed with the AEC as a practical estimate. Written confirmation obtained in advance, with the reply retained, is the safest basis for the dossier decision.

4. Practical recommendations

1. Submit the QMS certificate together with its annexes (the scope pages), and confirm that the scope covers the product and the sites applied for registration.
2. Set a reminder six months before the expiry of the QMS certificate, so as not to affect re-registration.
3. Check that the manufacturer name and address on the certificate are identical with the proof of the manufacturing right under 4.2.1 and the foreign registration certificate under 4.2.2.
4. In local production cases, invoke the exemption of Article 4.3 for item 4.2.9 in the covering letter.
5. Where the system standard is not ISO 13485, confirm acceptance with the AEC in writing and retain the reply.
6. After the QMS certificate is reissued or its scope changes, assess whether a change of state registration under Article 1.5 is triggered.

5. Verification checklist

• □ The main QMS certificate and its scope annexes have been submitted.
• □ The scope has been confirmed to include the product and the sites applied for registration.
• □ The manufacturer name and address have been checked against the documents under 4.2.1 and 4.2.2.
• □ A reminder six months before the expiry of the QMS certificate has been set.
• □ In local production cases, the exemption under Article 4.3 has been invoked.
• □ A system other than ISO 13485 has been confirmed with the AEC in writing.

Related reading: Manufacturer Production Right Document and Annexes (https://www.grzanglobal.com/azerbaijan-medical-device-registration/manufacturer-production-right-document/); 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/); Five-Year Validity: Article 6.11 of the Law and Article 8.1 of the Rules (https://www.grzanglobal.com/azerbaijan-medical-device-registration/five-year-validity-of-certificate/).

GRZAN provides regulatory consulting for medical device manufacturers and exporters, covering Azerbaijan state registration dossiers, quality management system evidence, certificate validity planning and AEC liaison. For tailored support on this topic, contact GRZAN at info@grzanglobal.com.

Regulatory information verified as of October 30, 2026.