France ANSM Registration
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
Class IIa Medical DevicesClass IIb Medical DevicesClass III Medical Devices
Active Implantable Medical Devices (AIMDD – Directive 90/385/EEC)
Data to Be Communicated to France ANSM Registration
- Trade name of the medical device
- Name and address of the person making the communication
- Labelling in French language
- Instructions for Use (IFU) in French language
Who Should Make This Communication?
Distributor
Manufacturer
Authorised Representative
When to Make This Communication
This communication must be made when a medical device is placed into service
within the French territory.
How OMC Medical Can Assist You With the Process
- Act as your European Authorized Representative (EU AR)
- Assist with French registration by completing forms and registering the device with ANSM
- Translate regulatory documents into French for submission
- Ensure compliance with French medical device regulatory requirements
Why Choose Us?
Client Satisfaction
Dedicated focus on meeting client expectations
Cost-Effective Solutions
Efficient regulatory strategies with optimized costs
On-Time Project Completion
Strict adherence to regulatory timelines
Quality Regulatory Affairs
High standards of regulatory compliance and expertise
Ready to Streamline Your Regulatory Compliance?
Join hundreds of companies who trust OMC Medical for their regulatory needs.
