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U.S. Department of Health and Human Services

For Industry

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What must I do to import medical devices and radiation-emitting products into the US?

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.

To find more information about importing medical device, please visit the Device Advice webpage ‘Importing into the U.S.’

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