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《China Medical Device Information》 2006-01
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U.S. Food and Drug Administration Requirements for Importing Medical Devices into the United States

Neil F. O'Flaherty Olsson, Frand and Weeda P.C (Washington DC, US)  
In addition to complying with the import requirements of the U.S. Bureau of Customs and Border Protection, a foreign manufacturer of a medical device, wishing to distribute its product in the United States, must also comply with the import requirements of the U.S. Food and Drug Administration (FDA). These requirements include establishment registration, medical device listing, quality system, medical device reporting, premarket approval or clearance, labeling and U.S. agent requirements. Understanding the requirements that apply to your company and its medical devices, and taking orderly measures to come into compliance with these requirements prior to attempting to import medical devices into the United States, are vital to your success. This article briefly describes FDA’s requirements for manufacturers importing medical devices into the United States and provides recommendations for preparing for device importation.
【CateGory Index】: F757.12
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