| Regulatory Authority | Analytical Expertise Center is regulatory authority of the Ministry of Health in the pharmaceutical field in Azerbaijan Republic. |
|---|---|
| Regulatory Authority Website Link | Click Here |
| Device Classification | The classification of medical devices depending on the degree of risk is determined by the body (institution) determined by the relevant executive authority. |
| Medical Device Regulations | Medical Device Legislation Law of The Republic of Azerbaijan No. 208-IIIQ dated December 22, 2006 on medicinal products | Click Here |
| Device Classification Guidelines | Classification of medical devices depending on the degree of risk | Click Here |
| Registration Process | Currently, there are no regulations on the registration of medical devices. It is regulated by the import process |
| Registration Timeline | 1 to 2 months, the overall timeline can be extended depending on classification |
| Requirement of Authorized Representative | Yes |
| Language Requirement | Instructions for use of medicinal products produced in the Republic of Azerbaijan or imported into the country must be in the Azerbaijani language |
| Additional Information | The certificate of state registration of drugs and medical devices, as well as medicinal substances, is valid for 5 (five) years. |
| Contact Phone | (+99412) 596 07 12 |
| Contact Email | aem@pharma.az |
| Contact Address | AZ1065, Azerbaijan, Baku, Yasamal district, J. Jabbarli street, 34 |