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  1. Device Advice: Comprehensive Regulatory Assistance

Importing and Exporting Medical Devices

Foreign establishments that manufacture medical devices and/or radiation-emitting electronic products that are imported into the United States (U.S.) must comply with applicable U.S. regulations before, during, and after importing into the U.S. or its territories.

Any medical device, including a radiation-emitting electronic product that is also a medical device may be exported anywhere in the world without prior FDA notification or approval to export, if it can be legally marketed in the U.S. A device that has not been approved, cleared or otherwise exempted from pre-market notification requirements for marketing in the U.S. must follow the export provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act).