ASNM - French Agency for the Safety of Health Products
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 the French government agency with jurisdiction over 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It superseded the AFSSAPS (l’Agence française de sécurité sanitaire du médicament et des produits de santé) on May 1st, 2012 and received a broader authority to monitor and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.
A list of EU regulations can be found here on our website.
Contact details:
- Website: http://ansm.sante.fr/
Medical Device Associations in France:
- Comident
- Comité Interprofessionnel des Fournisseurs du Laboratorie (CIFL)
- French National Association for Medical Technology Industries (SNITEM)
- Syndicat des Fabricants et Fournisseurs d'Optique de Contact (SYFFOC)
Related services:
- CE Mark Certification for Medical Devices
- Clinical Evaluation Reports (CER) for Medical Devices in Europe
- EU IVDR Gap Assessment and CE Transition for IVD Companies
- EU MDR compliance consulting for cosmetic and aesthetic products
- EU Medical Device Vigilance Reporting in Europe
- EU Post-Market Clinical Follow-up Studies (PMCF) for Medical Devices
- European Authorized Representative for Clinical Trials
- European Authorized Representative for Medical Device Companies
- European MDR 2017/745 Gap Assessment and CE Transition Strategy
- European Union Medical Device Classification
- In Vitro Diagnostics Regulation (EU IVDR) On-Site Training
- IVD Certification and Registration to Obtain CE Marking in Europe
- Medical Device and IVD Emergency Use Routes in Europe
- Medical Device Technical File and Design Dossier for EU CE Marking
- Switzerland Representative for Medical Device Companies
- UKRP and Brexit consulting for medical device companies