France · National Agency for the Safety of Medicines and Health Products · Diagnostics (IVD)
Review target
-
Not published
Legal time limit
-
Not published
Steps
1
3 requirements
Application fee
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In vitro diagnostic devices are CE marked under the EU rules. France also requires distributors and sterilisers active in France to declare their activities to the ANSM, and manufacturers selling in France to declare a reactovigilance contact. Information supplied with the device is in French. IVD distributors and sterilisers in France, and manufacturers placing IVDs on the French market.
1. National declaration.
Outcome: Declaration recorded by the ANSM.
Legal basis: Code de la santé publique, Article L.5221-4 and Articles R.5221-4 to R.5221-6; Regulation (EU) 2017/746
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
Official step durations
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| No time targets published. |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (7 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.