Useful links

Below, you will find some useful links on standards, players and international markets.

REGULATIONS

Agence nationale de sécurité du médicament et des produits de santé : ansm.sante.fr

European Committee for Standardization: www.cen.eu

European Community website : ec.europa.eu

International Medical Device Regulators Forum : www.imdrf.org

Haute Autorité de la Santé (French Health Authority) : www.has-sante.fr

Journal Officiel : www.journal-officiel.gouv.fr

List of notified bodies : See the list

List of MEDDEV recommendations : See the list

Europe: list of competent authorities for medical devices: See the list

“NBOG” documents issued by competent European authorities:  See the documents 

 

Export

FDA database for medical devices : Medical Device Databases

Website of the Canadian Ministry of Health : www.hc-sc.gc.ca

Brazil : ANVISA (National Health Surveillance Agency)

China: CFDA (Chinese Food and Drug Administration)

Japan : PMDA (Pharmaceuticals and Medical Devices Agency)

Australia :  TGA (Therapeutic Goods Administration)

 

Standards

ISO standards: See the catalogue

European standards (CEN): standards.cen.eu

List of medical device and IVD harmonised standards : See the list