France ANSM Registration

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:

  • 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 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.co.uk