Importing Medical Devices

In general, all importers must comply with law 21 USC 38 on Imports & Exports. Medical devices must comply with FDA requirements before release by the Customs Border Patrol. A useful checklist (not comprehensive, please consult your customs broker) would include

  • establishment registration of the manufacturer and the importer with the FDA
  • listing the device with the FDA
  • complying with Quality System Regulation or Good Manufacturing Practices
  • obtaining premarket notification (510(k)) determination unless exempted
  • complying with labelling requirements. Please note the latest FDA requirement for Unique Device Identifier
  • medical device reporting
  • appointment of a designated US agent

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