Medical device players
Identify the key players involved in medical devices
For your market entry challenges
-
Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM)
-
The ANSM is in charge of monitoring the market for health products, including medical devices (MDs)
As the competent authority, it is responsible for assessing, designating and monitoring Notified Bodies (NBs) in France
-
-
The Notified Bodies issue the EC certificate
- Several NBs may be designated in the same country.
- These NBs may have specific areas of expertise.
-
An MD manufacturer is free to choose any NB it wishes, provided the MD to be assessed falls within the scope of the body's competence.
For your reimbursement challenges
-
The Haute Autorité de Santé (HAS)
- The HAS evaluates drugs, medical devices and care procedures to decide on their reimbursability.
-
The Comité économique des produits de santé (CEPS)
- The CEPS comes up with reimbursement rates for products and services
Supportive players
-
The SNITEM
- The Syndicat national de l'industrie des technologies médicales (SNITEM) is a federation representing medical device companies
-
The SIDIV
- A trade union representing in vitro diagnostic medical devices