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Do I need to obtain FDA Premarket Approval (PMA) for imports of medical devices?
In order to import medical devices subject to Premarket Approval (PMA) into the U.S., the device must have FDA approval through the PMA process as well as meet all applicable FDA regulatory requirements. At this time, FDA does not recognize regulatory approvals from other countries. Exporting Medical Devices provides a summary of FDA requirements for foreign manufacturers and importers of medical devices and products that emit radiation.
U.S. Food and Drug Administration (FDA)
http://www.fda.gov
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