As with any product, medical and cosmetic products are subject to mandatory state registration. The registration process involves expertise and certification. State expertise in our Republic is carried out by the Center for Analytical Examination LLC under the Ministry of Health of Azerbaijan.
We provide comprehensive support for the process of expertise and certification of the product at all stages. The algorithm of the work performed is as follows.
Expertise (1st stage)
A confidentiality agreement is concluded and we receive from the manufacturer the dossiers in electronic form.
Our experts will review the documentation within 1-2 days and indicate the exact cost of the registration procedure.
After negotiating the price, we will enter into an agreement for registration services with you, and we will deal with turnkey registration
Developed instructions for use in the Azerbaijani language according to local requirements.
Labeling is developed in compliance with legal requirements.
We obtain permission to import samples and carry out customs clearance of samples .
A registration dossier and samples are provided to the Center for Analytical Experts LLC, An agreement is concluded for expertise and a fee is paid.
The current situation in the registration procedure is monitored and the client is constantly informed.
After the completion of the expertise, we get an expert conclusion on assigning the product status of a medical (cosmetic) product. The shelf life of expert conclusion is unlimited.
Certification (Stage 2)
Based on the conclusion of the expertise, documents are submitted (Contract with the manufacturer, invoice, certificate of analysis, certificate of origin) to the Food Safety Agency of the Republic of Azerbaijan for obtaining a Certificate of Food Safety which gives the right to import and sell medical (cosmetic) devices in the territory of the Republic of Azerbaijan. Shelf life of the Certificate is valid untill the expiry date of the food supplements with a certain batch number or during 6 months.
The average registration period is 1-2 months.
A list of documents for conducting of expertise of medical(cosmetic) devices
- The certificate of registration of the product in manufacturing country
- Free Sale Certificate
- The electronic versions of the artworks-Indicated information on artworks may be in English, Russian or Turkish languages. “This product is not a medicine. Medical (Cosmetic ) Device” should be indicated on there. If artwork of sample has a symbol of CE/EAC, in this case Conformita CE or CE Declaration should be submitted.
- Approved leaflet by applicant company. Composition, name of plant origin ingredients in latin language, recommendation for use, doses, side effects, contradictions, special warnings and precautions for use , shelf life and storage condition , registration status and information concerning product is not a medicine should be indicated on there.
- Certificate of Analysis according to batch number of submitted product sample
- Product sample
- The letter about trade name under which food supplement will be marketed in Azerbaijan