| 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 |
| Conformity Assessment Route |
Conformity Assessment Procedures | Click Here |
| 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 |
| Contact Phone | +355 42 376045 |
| Contact Email | akbpm@shendetesia.gov.al |
| Contact Address | Rr. e Dibres nr 359/1 Tirane, Shqiperi |