International Issues - Non U.S. Medical Device Regulators

Center for Devices and Radiological Health, U.S. Food and Drug Administration

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Non U.S. Medical Device Regulators

Web sites of selected foreign medical device agencies containing information on the requirements for marketing medical devices outside the United States.

Autralia Theraapeutic Good Administration	Regulation of medical devices and pharmaceutical products in Australia
Canada - Health Canada About/How to Reach Health Canada Canadian Quality System Requirements	Regulation of all medical products in Canada, and other Canadian government health programs
CE Marking	Swedish government site which provides specific information regarding CE marking, which is necessary to market medical devices in the European Community member nations
European Union (EU)	Multi-lingual gateway to information about all activities of the European Union
EU Medical Device Directives	Links to all three EU Medical Devices Directives on the European Union On Line (EUROPA); Medical Devices Directive (MDD); Active Implantable Medical Devices Directive (AIMDD); and the In Vitro Diagnostic Directive (IVDD)
Japan - National Institute of Health Sciences	Provides useful information about the regulation of medical devices and pharmaceutical products in Japan
Korean Food and Drug Administration	Regulation of food, drugs, cosmetics and medical devices in Korea
United Kingdom - Medical Device Agency	Information about the regulation of medical devices in the United Kingdom

Updated 5/1/03

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