Medical device players

Identify the key players involved in medical devices

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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

     

    Read about the ANSM

  • 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.

    The list of NBs by country is available in the NANDO database

For your reimbursement challenges

  • The Haute Autorité de Santé (HAS)

    • The HAS evaluates drugs, medical devices and care procedures to decide on their reimbursability.
    Read about the HAS

  • The Comité économique des produits de santé (CEPS) 

    • The CEPS comes up with reimbursement rates for products and services
    Read about the CEPS

Supportive players

  • The SNITEM

    • The Syndicat national de l'industrie des technologies médicales (SNITEM) is a federation representing medical device companies
    Read about the SNITEM

  • The SIDIV

    • A trade union representing in vitro diagnostic medical devices
    Visit the SIDIV website

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