Biomedical Engineering Reference
In-Depth Information
Table A.1: European Competent Authorities for Medical Devices
EC Country
Competent Authority
Website
Latvia
State Agency of Medicines
Medical Devices
Evaluation Department for Latvia
Liechenstein (EFTA)
Amt für Gesundheit
Lithuania
The State Health Care Accreditation Agency under the
Ministry of Health of the Republic of Lithuania
Luxembourg
Ministère de la Santé - Direction de la Santé
Malta
Malta Standards Authority
Regulatory Affairs Directorate
Netherlands
Dutch Healthcare Inspectorate
Norway (EFTA)
Sosial-og helsedirektoratet Norwegian
Directorate for Health and Social Affairs
Poland
The Office for Registration of Medicinal Products
Medical Devices and Biocidal Products
Portugal
Infarmed
National Authority of Medicines and Health Products, IP
Unidade de Vigilância de Produtos de Saúde
Romania
Ministry of Health
Slovenia
Agency for Medicinal Products and Medical Devices of
the Republic of Slovenia
Slovakia
State Institute for Drug Control
Medical Devices Section
Spain
Ministerio Sanidad y Consumo
Agencia Espaˇola de Medicamentos y Productos
Sanitarios
Sweden
Medical Products Agency “Läkemedelsverket”
Medical Devices
Switzerland (EFTA)
Swissmedic
Medical Devices Division
Turkey (Candidate)
Ministry of Health
DG for Pharmaceuticals and Pharmacy
Department of Medical Device Services
Market Surveillance Section
United Kingdom
Medicines & Healthcare products Regulatory Agency
(MHRA)
Table A.2: Summary of Websites Referred to in Chapter 2
American Society for Testing and Material (ASTM)
British Standards Institute (BSI)
FDA: Databases
FDA: Recognized Consensus Standards
International Organization for Standardization (ISO)
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