State registration of medical devices in Azerbaijan is not required.  

For the import of medical devices and medical equipment, it is necessary to obtain a confirmation letter regarding the classification of such products, and then obtain a hygiene certificate from the Republican Center for Hygiene and Epidemiology of the Republic of Azerbaijan.

Labeling requirements:

For registration of medical devices in Azerbaijan, the documentation is submitted in Azerbaijani, Russian or English.

The instructions (user manual) should be submitted in Azerbaijani.

At the Applicant’s choice, labeling may be presented either in Russian, English, or in Azerbaijani; labeling in Turkish is allowed.

The procedure for obtaining all necessary documents for import and placement on the market takes about 1-1.5 months.

Cratia provides professional services on the market authorization of medical devices in Azerbaijan. We have an excellent knowledge of national legislation, necessary experience and resources. 

To start cooperation or get advice, please contact us by phone: +38 068 064-78-31, +38 044 223-61-67, by e-mail: info@cratia.ua, or visit our office.