Medical Device Regulatory Requirements in France
| Regulatory Authority |
National Agency for the Safety of Medicines and Health Products (ANSM) |
| Regulatory Authority Website Link |
Click Here
|
| Device Classification |
I, IIa, IIb and III |
| Medical Device Regulations |
Regulations relating to medical devices
| Click Here
|
| IVD Classification |
A,B,C,D |
| In Vitro Diagnostics Regulations |
(EU) 2017/746
| Click Here
|
| Registration Process |
Registration of Medical Device
| Click Here
|
| Registration Timeline |
For Class I, it is 1 to 2 months and for other classes, it depends on the notified body and type of product |
| Requirement of Authorized Representative |
Yes |
| Language Requirement |
Labels must be in French Language |
| Database |
EUDAMED
| Click Here
|
| Additional Information |
The ANSM is involved in European and international work. Its activities are part of European procedures and its work is coordinated with the European Medicines Agency, the European Commission and the other national agencies of the European Union. It also collaborates with international health organisations. |
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 We are not responsible for errors, omissions, or outdated content.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