France Medical Device Regulations
Regulatory Authority: Agence Nationale de sécurité de médicament et des produits de santé
Link for MoH: https://ansm.sante.fr/
Local Listing or Registration: Yes, Local listing is required.
Local regulation: French law articles L.5211-4 and R.5211-66
Medical devices concerned:
- I class medical devices
- IIa class medical devices
- IIb class medical devices
- III class medical devices
- Active implantable medical devices (AIMDD) as defined in the European directive 90/385/EEC
Data to be communicated to ANSM:
- Trade name
- Name and address of the person making the communication.
- Labelling, Instructions of Use in French language
Who should make this communication:
- Authorised Representative
When to make this communication?:
When a medical device is put into service into the French territory.
How OMC Medical can assist you with the process
- Act as your EU AR
- Help you with the French registration by filling in the form and registering the medical device with the ANSM authorities.
- Translate your documents to French for submission.
Why Choose Us
- Working towards client satisfaction
- Cost effective solutions
- Project completion before deadline
- Quality Regulatory affairs solutions
Contact us for free consultation: [email protected]co.uk