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 from the United States to anywhere in the world without prior FDA notification or approval to export, if it can be legally marketed in the United States. A device that has not been approved, cleared, or otherwise exempted from pre-market notification requirements for marketing in the United States must follow the export provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act).