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
- 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 France ANSM Registration
- 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 France ANSM Registration 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: info@omcmedical.