France · National Agency for the Safety of Medicines and Health Products · Medical devices
Review target
-
Not published
Legal time limit
-
Not published
Steps
2
6 requirements
Application fee
-
Medical devices reach the market with a CE mark under the EU rules. On top of that, France requires some operators to declare their activities to the ANSM: distributors in France, makers of custom-made devices and sterilisers. Manufacturers selling in France declare a materiovigilance contact. Labels and instructions are in French. Distributors, custom-made device manufacturers and sterilisers active in France, and manufacturers placing devices on the French market.
1. EU database registration; 2. National declaration.
Outcome: Declaration recorded by the ANSM; EU registrations in the EU device database.
Legal basis: Code de la santé publique, Article L.5211-3-1 and Articles R.5211-6 to R.5211-8; Regulation (EU) 2017/745
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. |
Other routes in France: Derogation for a device without CE marking, Early coverage for digital medical devices. See all routes on the France page or explore them in the Regulatory section.
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 (11 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.