International Regulations for Medical Devices
This page contains information about several large international medical device markets (Australia, Canada, China, Europe and Japan) as well as information applicable to the world market.
Worldwide
Links to Ministry of Health Websites Worldwide
EU Medical Device Approval Safety Assessment (Boston Consulting Group - BCG), Jan 2011
Australia
Therapeutic Goods Administration (TGA)
TGA Medical Device Regulations
Regulatory Process (pdf, Emergo Group)
Medical Device Consulting Services for Australia
Canada
Health Canada
Canadian Medical Device Regulations (CMDR)
Regulatory Process (pdf, Emergo Group)
Medical Device Consulting Services for Canada
China
State Food & Drug Administration (SFDA)
China Medical Device Regulations
Regulatory Process (pdf, Emergo Group)
Medical Device Consulting Services for China
China Compulsory Certification
Europe
European Medical Device Regulations
Regulatory Process (pdf, Emergo Group)
Medical Device Consulting Services for Europe
Japan
Pharmaceuticals & Medical Devices Agency (PMDA)
Japan Medical Device Regulations
Regulatory Process (pdf, Emergo Group)
Medical Device Consulting Services for Japan