Medical Device Regulatory Requirements in Albania
| Regulatory Authority |
National Agency for Medicines and Medical Devices |
| Regulatory Authority Website Link |
Click Here
|
| Device Classification |
I, IIa, IIb and III |
| Medical Device Regulations |
Law No 89/2014 for Medical Device
| Click Here
|
| Registration Process |
Procedures And Rules For The Registration Of Medical Devices
| Click Here
|
| Registration Timeline |
5 days for Class 1 and 30 days for Class IIa, IIb and III |
| Requirement of Authorized Representative |
Yes |
| Language Requirement |
Labels must be in Albanian Language |
| Additional Information |
Manufacturers of medical devices that have registered activity in the Republic of Albania must submit the application for registration within 15 days from the day of issuing the |
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 We are not responsible for errors, omissions, or outdated content.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