Medical device players
Identify the key players involved in medical devices
Concerning your marketing challenges
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Agence Nationale de Sécurité du Médicament et des Produits de Santé (French National Agency for Drug and Health Product Safety)
Consult the ANSM fact sheet-
The ANSM is notably in charge of market surveillance for healthcare products, which include medical devices (DM)
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As a competent authority, is responsible for assessing, designating and controlling notified bodies (NBs) in France.
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Notified Bodies issue the CE certificate,
The list of NBs by country is available on the NANDO database.- Multiple NBs may be designated in the same country.
- These NBs may have specific areas of competence.
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A DM manufacturer is free to choose any NB it wishes, provided that the DM to be assessed falls within the organization's field of competence.
About your reimbursement challenges
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The French Health Authority
Consult the HAS fact sheet- The HAS evaluates drugs, medical devices and professional acts for reimbursement
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The Economic Committee for Health Products
Consult the CEPS fact sheet- The CEPS proposes reimbursement rates for products and services
Supporting players
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SNITEM
Consult the Snitem fact sheet- Syndicat national de l'industrie des technologies médicales represents medical device companies
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SIDIV
Visit the SIDIV website- Syndicat , represents in vitro diagnostic medical devices
