Medical Device Regulatory Requirements in Russia
| Regulatory Authority |
Federal Service for Surveillance in Healthcare |
| Regulatory Authority Website Link |
Click Here
|
| Device Classification |
I, IIa, IIb and III |
| Medical Device Regulations |
CE Marking process
| Click Here
|
| Registration Process |
Medical Device Registration
Registration certificate for medical devices
| Click Here
|
| Registration Timeline |
10 to 16 months |
| Requirement of Authorized Representative |
Yes |
| Language Requirement |
Labels must be in Russian Language |
| Additional Information |
The presence of the CE mark on a product (CE Mark) is a necessary condition for its free circulation in the countries of the European Union and the European Economic Area. This requirement applies to all goods, regardless of the place of their production - in the EU or in third countries. |
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 We are not responsible for errors, omissions, or outdated content.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