Important Links for the Medical Device Community
Please use the following in categories selected links for further information:
Authority:
- European Union Homepage on Medical Devices
- MEDDEV - Guidelines relating to the Medical Device Directive
- New Approach Standardisation in the Internal Market
- NBOG - Notified Body Operating Group
- FDA - USA Food & Drug Administration
- Canada Health Product & Food
- Department of Health, Taiwan
- DIMDI - German Institute of Medical Documentation and Information
- Robert Koch Institute
- ZLG - Central Authority for Health Protection with regards to Medical Products & Medical Devices
- Health Monitoring System of Germany (Federal)
- Italian Authority - Ministero della Salute
- Spanish Authority - Ministerio de Sanidad y Consumo
- Portuguese Authority - Instituto Nacional da Farmácia e do Medicamento
- BfArM - Federal Institute for Drugs and Medical Devices
- MHRA - Medicines and Healthcare Prouducts and Regulatory Agency
- List of Notified Bodies
- PEI - Paul-Ehrlich Institut
Associations:
- BvMed - German Medical Technology Association
- EAAR - European Association of Authorized Representatives
- European Association of Notified Bodies for Medical Devices
- AMA - American Medical Association
- EUDOMED - European Confederation of Medical Devices Associations
- EDMA-Code - European Diagnostic Manufacturers Association
Standards:
- ISO - International Organization for Standardization
- ISO 9000 - Information on ISO 9000 revision from ISO/TC176/SC2
- BSI - British Standards Association
News:
Nomenclature:
- GMDN-Code - Global Medical Device Nomenclature
- EDMA-Code - European Diagnostic Manufacturers Association
- UMDNS-Code - Universal Medical Device Nomenclature System at Ecri Institute
