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:
Data to be communicated to ANSM:
Who should make this communication:
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
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