CASubmissionOfApplication object

Sponsor
Legal representative

The sponsor must connect to the ANSM website to obtain a registration number for research (ID RCB).

Yes

(1) A comprehensive guidance for sponsors is available for download on the ANSM website in French !

Recherches impliquant la personne humaine portant sur des dispositifs médicaux ou sur des dispositifs médicaux de diagnostic in vitro - Avis aux promoteurs (14/06/2017)

Available at : http://ansm.sante.fr/Activites/Dispositifs-medicaux-et-dispositifs-medicaux-de-diagnostic-in-vitro/Essais-cliniques-portant-sur-les-dispositifs-medicaux-et-dispositifs-medicaux-de-diagnostic-in-vitro/(offset)/0#dm

See also :
(2) Decree of 16 August 2006 ('Decree AEC') fixing the contents, the format and the methods of presentation to the French Agency for Medical Safety of products of health of the dossier for request for authorisation of biomedical research relating to a medical device or in vitro diagnostic medical device

Radiopharmaceutical drugs:
The use and the detention of radionuclides, for their use in biomedical research, and products or devices containing them, are subject to authorisation by the minister in charge of health. A copy of this authorisation, delivered by the Directorate-General of nuclear safety and protection against radiation (DGSNR), must be added to the application dossier of request for AEC.

Blood/ tissue samples (circulation and storage): additional forms have to be submitted to the CA.