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France ANSM Registration

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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: 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?

  • 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

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