Medical device registration in Azerbaijan has been mandatory since 2024. Under Resolution No. 345 of the Cabinet of Ministers, dated July 18, 2024, the import, production, and sale of medical devices is permitted only after state registration.

This guide covers the full process — which devices require registration, the documents you need, each stage of the procedure, realistic timelines, and how professional support can streamline everything.

What Changed in 2024?

Previously, medical devices could be imported and marketed in Azerbaijan without registration. That changed with Law No. 979-VIQD of July 14, 2023, which amended the Law of the Republic of Azerbaijan “On Medicinal Products.”

As of July 19, 2024, all medical devices — except those classified as Risk Class I — require state registration before they can be imported, produced, sold, or used in the country.

The responsible regulatory body is the Analytical Expertise Center (AEC) under the Ministry of Health of the Republic of Azerbaijan.

Which Medical Devices Require Registration?

Decision No. 8 of the Ministry of Health, dated May 21, 2024, classifies medical devices by risk level:

• Risk Class I (low risk) — Registration is not required, but a one-time import permit must be obtained for each batch
• Medium risk level — Mandatory state registration
• High risk level — Mandatory state registration
• Higher risk level — Mandatory state registration

Important: Azerbaijan’s risk classification system differs significantly from both the European Union and U.S. frameworks. Each device’s risk class must be determined according to Azerbaijani legislation, regardless of its classification in the country of origin.

Documents Required for Registration

To obtain state registration, the applicant must submit the following to the Analytical Expertise Center:

1. A copy of the document confirming the manufacturer’s production rights and its annex
2. A notarized copy of the state registration certificate from the country of manufacture, translated into Azerbaijani (if not registered in the country of manufacture, registration documents from other countries are accepted)
3. Free sale or export certificate (if available)
4. A brief description of the device’s application, purpose, and composition, provided by the manufacturer
5. Packaging and labeling materials — color mock-ups in Azerbaijani
6. Instructions for use, with notarized translation into Azerbaijani
7. For sterile devices — notarized copies of validation protocols, bioburden testing results, pyrogenicity and sterility test reports, and process validation documentation, translated into Azerbaijani
8. The manufacturer’s declaration of compliance with safety and effectiveness requirements, indicating the assigned risk level
9. A copy of the quality management system certificate issued by the manufacturer
10. Documents stipulated in Articles 18.2.1–18.2.3 of the Law of the Republic of Azerbaijan “On Licenses and Permits”

If CE/EAC markings are present on the device, a declaration of conformity must also be submitted.

Steps of the Registration Process

Step 1 — Classification and Assessment

The first step is to correctly determine the device’s risk class under Azerbaijani legislation. This is the most critical stage — incorrect classification can result in rejection and force the entire process to restart.

Step 2 — Document Preparation and Localization

Technical documentation is reviewed and adapted to Azerbaijani requirements. User manuals are translated into Azerbaijani with notarization. Packaging mock-ups are prepared. Certain documents require notarized certification.

Note: Documents may be submitted in Russian, English, or Azerbaijani, but the instructions for use must be in Azerbaijani.

Step 3 — Submission to AEC and Examination

The completed dossier is submitted to the Analytical Expertise Center. The AEC conducts an examination and may request additional documents or clarifications.

Step 4 — Issuance of Registration Certificate

Upon successful completion of the examination, a separate registration certificate is issued for each medical device. The certificate is valid for 5 years. Re-registration applications must be submitted at least 90 calendar days before the current registration expires.

Post-marketing requirements: Currently, the regulator does not require routine post-marketing reports. However, serious and unexpected adverse events must be reported within 3 days. These requirements are expected to expand in the future.

Timelines and Timeframes

Timelines depend on the completeness of the document package and the number of additional queries from the AEC.

Special Requirements for Foreign Companies

For medical devices imported from China, Turkey, Europe, or other countries, additional considerations apply:

• The registration certificate from the country of manufacture must be translated into Azerbaijani with notarization
• If the device is not registered in the country of manufacture, registration documents from other countries must be provided
• A Free Sale Certificate can help accelerate the process
• Appointment of a local representative or contact person may be required
• All notarized documents must be legalized according to Azerbaijani requirements

Why Professional Support Makes a Difference

The most common issues encountered during medical device registration in Azerbaijan include:

• Incorrect classification — assigning the wrong risk class forces the entire process to restart from the beginning
• Incomplete dossier — missing documents trigger additional AEC queries, causing significant delays
• Translation errors — non-compliance with notarized translation requirements can serve as grounds for rejection
• Packaging non-compliance — failure to include mandatory statements (such as “This product is not a medicinal product. It is a medical device”) on packaging materials

Professional regulatory support minimizes these risks, ensures first-submission acceptance of documents, and can reduce the overall timeline by 30–50%.

Frequently Asked Questions

What is required for Risk Class I devices?

Registration is not required for Risk Class I devices. However, a one-time import permit must be obtained from the AEC for each batch.

How long is the registration certificate valid?

The registration certificate is valid for 5 years. Re-registration applications must be submitted at least 90 calendar days before the certificate expires.

In which languages are documents accepted?

Documents may be submitted in Russian, English, or Azerbaijani. However, the instructions for use (user manual) must be in Azerbaijani.

Are post-marketing reports required?

Currently, the regulator does not mandate routine post-marketing reports, pharmacovigilance system establishment, or electronic system filings. However, all serious and unexpected adverse events must be reported to the competent authority within 3 days. These requirements are expected to be expanded in the future.

Can used medical equipment be registered?

Yes — provided the manufacturer’s document confirming the device’s suitability for use is notarized and translated into Azerbaijani with notarization.

Does the risk class from my country apply in Azerbaijan?

Not necessarily. Azerbaijan adopted its own national classification system through Ministry of Health Decision No. 8 (May 21, 2024) and Decision No. 9 (list of devices by risk level). Your device’s risk class must be determined according to Azerbaijani legislation.

Planning to register medical devices in Azerbaijan? An initial consultation helps assess your product, determine the applicable risk class, and build the optimal registration strategy. Contact with us