Ministry of Health

Ministry of Health of the Republic of Azerbaijan

Regulatory Authority

CSEEA Analytical Expertise Centre

Medical Device Regulation

Law of the Republic of Azerbaijan, “On Medicinal Products”

Official Language

Azerbaijani

Classification

No defined classification

Registration Process

• For Import – Obtain confirmation letter for classification of products.
• Obtain Hygiene certificate from Republican Center for Hygiene and Epidemiology of the Republic of Azerbaijan
• Start marketing the device in Azerbaijan

Registration Timeline

30-45 days

Authorized Representative

Yes.

License Validity

5 years

Special Notes

Documents to be submitted in Azerbaijani, Russian, or English.

IFUs are to be submitted in Azerbaijani.