ANSM, the French Health Authority that is responsible for the identification of all medical devices that enter the French territory, requires notification of class IIa, IIb, III and active implantable medical devices. There is no online database system in France, but all manufacturers are required to inform ANSM by email. An application form must be included in this email message as well as all mandatory documentation. Use your precious time for other regulatory challenges and delegated this task to Qserve.
Notification requires between 2 and 6 hours per device depending on availability and quality of the mandatory documentation as well as the complexity of the device influenced by the number of models, components, accessories, manufacturing sites.