FR-ANSM-NOTIF
ANSM notification (France)
Obligation to notify the ANSM before placing a device on the French market
- Category
- National requirements
- Market
- France
- Applicable classes
- Class I medical device, Class IIa medical device, Class IIb medical device, Class III medical device
In practice
Declaration through the ANSM online service before commercialisation. Include manufacturer, authorised representative, classification and CE marking. Update on any change.
Official sources
https://ansm.sante.fr/vos-demarches/industriel/declarer-la-mise-sur-le-marche-dun-dispositif-medicalSee where this text lands in your roadmap
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