Biomedical Engineering Reference
In-Depth Information
APPENDIX A
Useful Websites
FDA Medical Devices
Table A.1: European Competent Authorities for Medical Devices
EC Country
Competent Authority
Website
Austria
Österreichische Agentur für Gesundheit und
Ernährungssicherheit GmbH
Institut Inspektionen, Medizinprodukte und
Hämovigilanz - AGES PharmMed
Belgium
(AIMDD, MDD)
Federal Public Service
Health, Food Chain Safety and Environment
Directorate General Public Health Protection:
Medicinal Products Medical Devices Unit
(IVDMD)
Scientific Institute of Public Health
Department of Clinical Biology
Bulgaria
Bulgarian Drug Agency Department of Medical Devices
Cyprus
Cyprus Medical Devices Competent Authority
Czech Republic
State Institute for Drug Control
Denmark
The Danish Medicines Agency
Estonia
Health Board
Medical Devices Department
Finland
Valvira - National Supervisory Authority for Welfare
and Health
France
Agence française de sécurité sanitaire des produits de
santé (AFSSAPS)
Germany
Federal Institute for Drugs and Medical Devices
Greece
National Organization for Medicines
Hungary
Authority for Medical Devices Budapest
Iceland (EFTA)
Directorate of Health
Ireland
Irish Medicines Board -
Medical Devices Department
Italy
Ministry of Labour, Health and Social Affairs
Department of Innovation
Directorate General of Medicine and Medical Devices
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