The National Agency for the Safety of Medicines and Health Products (L’Agence nationale de sécurité du médicament et des produits de santé or ANSM) is French government agency with jurisdiction across pharmaceuticals, biological products, medical devices and cosmetics. Created by the Act of 1 July 1998, the ANSM functions under the Ministry of Health and has the authority to monitor and regulate health products.
It superseded on May 1st, 2012 the AFSSAPS (l’Agence française de sécurité sanitaire du médicament et des produits de santé) and received a broader authority to monitor and evaluate health products, as well as a greater budget. The ANSM also actively participates in standardizing and harmonizing regulation and practices on the European market.
Some of the most important European regulations for medical devices in the EU are:
- CONSOLIDATED Medical Device Directive (93/42/EEC)
- CONSOLIDATED Active Implantable Medical Devices Directive (90/385/EEC)
- View as web page
- Personal Protective Equipment Directive (89/686/EEC)
A full list of EU regulations can be found here.
- Website: http://ansm.sante.fr/
Medical Device Associations in France: