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U.S. Department of Health and Human Services

Medical Devices

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Importing Medical Devices

Current listing of all registered foreign establishments exporting medical devices to the United States.
Describes current policies with respect to importations for trade shows/fairs, exhibitions, and special events. Although a firm may advertise or display a device that is the subject of a pending 510(k)--in the hope that FDA will conclude that the device is substantially equivalent to a pre-amendments device--a firm may not take orders, or be prepared to take orders, that might result in contracts of sale for the device unless limited to research or investigational use.
Provides a comprehensive search engine for information about import alerts. To search for medical devices, select "Industry," then "Medical Devices & Diagnostic Products," then the category of device of interest to you.
Guidance and policy concerning the importation of medical devices for the purpose of exportation.
International regulatory activities related to imports and inspections
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