Importing and Exporting Devices

Any medical device that is legally in the U.S. may be exported anywhere in the world without prior FDA notification or approval.  Devices that have not been approved or cleared in the U.S. must follow the export provisions of the FD&C Act.

Foreign firms that manufacture medical devices and/or products that emit radiation that are imported into the United States must comply with applicable U.S. regulations before, during, and after importing into the U.S. or its territories.

Use the links on the left side of this page to find more information about exporting and importing medical devices.