Governed by the European Union Medical Device and IVD Regulations (EU 2017/745, 2017/746)
| 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. |