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     for Medical Industries
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Regulatory Affairs
Quality Management Systems
Pre-Clinical and Clinical Investigations
EU and US Representation
R&D Support
Pricing and Reimbursement
Product Development
Training
Translation


Links

Europe
European Commission
European Medicines Agency (EMA)
Competent Authorities of European Community (pdf)
Germany - BfArM
UK – MHRA
Switzerland - SwissMedic
Medical Device Directives
Active Implantable Medical Device Directive (AIMD) (pdf)
Medical Devices Directive (MDD) (pdf)
In Vitro Diagnostic Medical Devices Directive (IVDD) (pdf)
MEDDEV Documents
European Harmonized Standards, Medical Devices

North America
FDA
FDA – Listing and Establishment Data Base
Health Canada

Asia
Pharmaceuticals and Medical Devices Agency Japan
Medical Device Bureau, Ministry of Health Malaysia
Health Sciences Authority Singapore
Medical Devices South Korea

Middle East
Saudi Food & Drug Authority

Australia
Australian Government Department of Health

New Zealand
New Zealand Medicines and Medical Devices Safety Authority

Russia
Certification in Russia

Standardization
European Committee for Standardization
European Committee for Electrotechnical Standardization
International Electrotechnical Commission
International Organization for Standardization
American National Standards Institute
Standards Worldwide
British Standards
German Institute for Standards
BEUTH, publishing house

Associations
German Medical Technology Association (Bundesverband für Medizintechnologie)
AdvaMed
Association for the Advancement of Medical Instrumentation
Association for Clinical Research Professionals
Association of Medical Diagnostics Manufacturers
EUCOMED
European Diagnostic Manufacturers Association (EDMA)
Medical Device Manufacturers Association (MDMA)
Regulatory Affairs Professional Society (RAPS)

Usefull Links
RAJ Devices
DeviceMed
Medical Device Industry Supplier Directory
German Medical product Journal (Medizinprodukte Journal)


Our site contains links to third-party Web sites. We have no influence whatsoever on the information on these Web sites and accept no guaranty for its correctness. The content of such third-party sites is the responsibility of the respective owners/providers.
At the time third-party Web sites were linked to ours, we found NO GROUNDS WHATSOEVER of any likely contravention of the law. We shall promptly delete a link upon becoming aware that it violates the law.



    
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