Introduction of medical device registration in Azerbaijan from July 2024

On July 19 and 20, 2024, the Cabinet of Ministers of the Republic of Azerbaijan adopted Resolutions No. 345 (introduction of state registration of medical devices and in-vitro diagnostic devices, new rules for the registration of medicines) and No. 347 (amendments to the procedure for the examination of medicines, medical devices, and in-vitro diagnostic devices).

The resolutions establish the rules for the state registration of medical devices in Azerbaijan, the procedure for submitting applications for new registration, the list of documents required for new registration, requirements for the legalization and language of documentation, the procedure for issuing a registration certificate and its validity period, the procedures for making changes (variations) and renewal of registration, inclusion of medical devices in the state register, and the maintenance of the state register.

The authorized body for the registration of medical devices is the Analytical Expertise Center (AEC) of the Ministry of Health of Azerbaijan.

On July 22, 2024, the Analytical Expertise Center published a notice suspending the import of unregistered medical devices (except for class I) from 22.07.2024.

According to Resolution No. 345, medical devices with increased, high, and medium risk levels are subject to state registration – all devices except for class I. Previously, on May 21, 2024, the Ministry of Health adopted Resolutions No.8 (classification depending on the degree of risk) and No.9 (list of devices with high and medium risk levels).

Please note that the classification of medical devices in Azerbaijan significantly differs from the classification in the European Union and the USA. The classification of a medical device and the decision on its registration must be carried out under the legislation of Azerbaijan.

Thus, for the import and introduction into circulation of higher-class medical devices and in-vitro diagnostic medical devices from 22.07.2024, it is necessary to carry out state registration.
 
 
Cratia provides professional assistance in the registration of medical devices in Azerbaijan. We have a strong local team and more than a decade of experience in regulatory procedures in Azerbaijan. We offer:

• Registration of medical devices in Azerbaijan; 
• All necessary consultations on regulatory requirements;
• Classification of the medical devices;
• Translation of documentation into the Azerbaijani language;
• Submission of Application and support of the assessment process;
• Renewals and changes (variations);
• Safety vigilance of medical devices in Azerbaijan.