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Post-Market Safety Reporting Notification

The MFDS Adverse Event Reporting Notification (의료기기 이상사둀 보고 및 μ•ˆμ „λŒ€μ±…μ— κ΄€ν•œ κ·œμ •) provides detailed requirements for adverse event reporting and safety management.

Key provisions​

  • Definition of reportable events
  • Reporting timeframes (15-day and 30-day)
  • Reporting forms and submission portal details
  • Investigation requirements after an event
  • FSCA and recall notification requirements
  • MFDS right to request additional information

Add under 'Reporting timeframes': "Death or serious injury: 15-day report to MFDS. Other adverse events and product defects: 30-day report. Expedited reporting (within 24–48 hours) required for events occurring at MFDS request or for publicly disclosed safety issues requiring immediate action. Initial report may be preliminary; complete investigation report must follow within agreed timeframe."