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U.S. Department of Health and Human Services

Medical Devices

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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.

Regulation of medical devices and pharmaceutical products in Australia
Swedish government site which provides specific information regarding CE marking, which is necessary to market medical devices in the European Community member nations
Multi-lingual gateway to information about all activities of the European Union
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)
Provides useful information about the regulation of medical devices and pharmaceutical products in Japan
Regulation of food, drugs, cosmetics and medical devices in Korea
Information about the regulation of medical devices in the United Kingdom
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