| Regulatory Authority | Ministry of Health of the Republic of Belarus |
|---|---|
| Regulatory Authority Website Link | Click Here |
| Device Classification | I, IIa, IIb and III |
| Medical Device Regulations | Regulations on State Registration (Re-registration) of Medical Devices | Click Here |
| Registration Process | Regulations on State Registration (Re-registration) of Medical Devices | Click Here |
| Registration Timeline | 3 to 5 months |
| Requirement of Authorized Representative | Yes |
| Language Requirement | Labels must be in Russian or Belarusian Language |
| Additional Information | The term of validity of the marketing authorisation for medical devices and medical equipment is 5 years. |
| Contact Phone | +375 17 373-70-80 |
| Contact Email | kanc@minzdrav.gov.by |
| Contact Address | Myasnikova st., 39, Minsk, 220030 |