International Issues - Importing Medical Devices

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

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Importing Medical Devices

FDA/CDRH Registered Foreign Establishments	Current listing of all registered foreign establishments exporting medical devices to the United States.
Device Importation for Trade Shows, etc	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.
FDA Import Alerts	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.
Import for Export	Guidance and policy concerning the importation of medical devices for the purpose of exportation.
Imports and Inspections	International regulatory activities related to imports and inspections

Updated 10/21/2002

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