| Regulatory Authority | Armenian Medical Products Regulatory Authority |
|---|---|
| Regulatory Authority Website Link | Click Here |
| Device Classification | I, IIa, IIb and III |
| Medical Device Regulations | Government of the Republic of Armenia N 429-N | Click Here |
| Registration Process | The registration of medical devices in RA is carried out under the rules of the Eurasian Economic Union. | Click Here |
| Registration Timeline | 10 months |
| Language Requirement | Documents attached to the application in foreign languages __(with the exception of Russian or English) are submitted with a certified Armenian translation in accordance with the legislation of the Republic of Armenia. |
| Labeling Requirements |
Labeling Requirements | Click Here |
| Additional Information | The applicant shall be issued a re-registration certificate valid for 5 five years which shall be calculated from the day following the completion of previous registration |
| Contact Phone | (+374 60) 83-00-73 |
| Contact Email | info@ampra.am |
| Contact Address | 49/5 Komitas av., Yerevan 0051, Republic of Armenia |