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