As of July 19, 2024, mandatory registration of medical devices has been introduced in Azerbaijan. Import, production, sale, and use of medical devices are allowed only after their state registration by the authorized body of Azerbaijan. Previously, medical devices could be imported and marketed without registration.
On July 19, the Cabinet of Ministers of the Republic of Azerbaijan approved Resolution No. 345 “On approval of the rules for state registration, inclusion in the state register, and maintenance of the state register of medicines, medicinal substances, and medical devices.” This resolution approves the rules for state registration of medical devices in Azerbaijan, the procedure for submitting an application for new registration and re-registration, the list of documents (dossier) required for new registration, requirements for legalization and language of documentation, the procedure for issuing a registration certificate and its validity period, the procedure for making changes, inclusion of medical devices in the state register, and maintenance of the state register.
On July 20, the Cabinet of Ministers of the Republic of Azerbaijan approved Resolution No. 347, which amended the procedure for the examination (expertise) of medicinal products, including medical devices. This resolution regulates the procedure for conducting expertise of medical devices during their state registration and quality control.
Import of unregistered medical devices and transition period
On July 22, the competent authority of Azerbaijan, the Center for Analytical Expertise of the Ministry of Health, published a notification that the import of unregistered medical devices is prohibited.
The notification also provides an exemption for importing devices with invoice and bank payment dates not exceeding the date of approval of the registration procedure (presumably July 19, 2024).
The legislation does not describe a transition period, and currently, there is a “hard” transition from no registration to mandatory registration of medical devices in Azerbaijan.
Which medical devices require registration?
According to Decision No. 345, medical devices with high, medium, and increased risk levels must be registered – all devices except class I. However, the classification of medical devices and in-vitro diagnostic devices in Azerbaijan significantly differs from the classification in the European Union and the United States.
On May 21, 2024, the Ministry of Health adopted Decisions No. 8 (national classification of medical devices based on risk level) and No. 9 (list of devices with high and medium risk levels).
Please note that the classification of a medical device and the decision to register it must be made according to Azerbaijani legislation.
State registration procedure for medical devices
Registration is conducted centrally by the competent authority of Azerbaijan responsible for the registration of medicinal products – the Center for Analytical Expertise of the Ministry of Health. To register, an Application and a set of documents (registration dossier) must be submitted.
The Application specifies the holder of the state registration certificate – the owner of the state registration certificate responsible for the quality, efficacy, and safety. The registration holder can be the manufacturer or another authorized person.
Some documents in the registration dossier must be submitted with a translation into Azerbaijani, and some documents require a notarized translation. Packaging layouts and colored labels in Azerbaijani language are also required.
The registration certificate is issued for 5 years.
Cratia professionally performs the service of state registration of medical devices in Azerbaijan. We are well-versed in national legislation and have the necessary experience and resources to carry out the work.
If you have any questions, we will be happy to answer them by email at info@cratia.com, by phone at +38(044)364-33-55, or at a meeting in our office.