| 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. |
| Registration Timeline | 10 months |
| Requirement of Authorized Representative | Yes |
| 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. |
| 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 |