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U.S. Department of Health and Human Services

For Industry

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What must I do to export medical devices and radiation-emitting products from the US?

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.

To find more information about importing medical device, please visit the Device Advice webpage ‘Exporting Medical Devices

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