Medical Device Regulatory Requirements in Belarus
| 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. |
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 We are not responsible for errors, omissions, or outdated content.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