France ANSM Registration

France ANSM Registration

France Medical Device Regulations

Regulatory Authority: Agence Nationale de sécurité de médicament et des produits de santé

Link for MoH:

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?

  • Distributor
  • Manufacturer
  • 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: