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Importer Licence (수입업 허가)

Korean importers of medical devices must hold an importer licence (수입업 허가) from MFDS.

Requirements​

  • Designated Quality Assurance Manager meeting MFDS requirements
  • Business registration in Korea
  • Must hold (or be eligible to hold) the 품목허가 / 품목신고 for imported products

Key importer obligations as licence holder​

  • Ensure foreign manufacturer maintains a valid GMP certificate recognised by MFDS
  • Korean-language labelling compliance
  • Adverse event reporting for products on the Korean market
  • Recalls and FSCAs when required

Application​

Submit via MFDS eSubmission portal (의료기기 전자민원).

Designated Quality Assurance Manager with qualifications meeting MFDS standards (typically requiring relevant academic background and experience in medical device quality assurance)