Medical Device Regulatory Requirements in Azerbaijan
| 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
|
| 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. |
Disclaimer: This website sources information from regulatory authorities and aims for accuracy, but regulations may change without notice. Users are advised to verify details with relevant authorities before making compliance decisions. We are not responsible for errors, omissions, or outdated content.
The above information is last updated on 09/Apr/2025