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Manufacturer vs Importer Obligations

Manufacturer obligations​

  • Investigate all adverse event reports received from any source
  • Report to MFDS within required timeframes (15-day or 30-day)
  • Maintain an adverse event complaint file
  • Take corrective action (FSCA, recall) when necessary
  • Update technical documentation and risk management file

Importer obligations​

  • Forward reports received from Korean healthcare facilities to the foreign manufacturer AND to MFDS
  • Maintain complaint records
  • Cooperate with the foreign manufacturer's investigation
  • Initiate a recall or FSCA if instructed by the manufacturer or MFDS

Healthcare facility obligations​

Must report to:

  1. The manufacturer or importer
  2. MFDS directly via the MFDS adverse event reporting portal