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Clinical Trials Notification

The MFDS Clinical Trials Notification (의료기기 μž„μƒμ‹œν—˜ κ³„νš 승인 등에 κ΄€ν•œ κ·œμ •) provides detailed requirements for obtaining clinical trial approval and conducting trials under Korean GCP.

Key provisions​

  • Application requirements for clinical trial approval
  • Minimum contents of a clinical trial protocol
  • Informed consent requirements
  • IRB submission requirements
  • Safety reporting during trials (serious adverse events)
  • Record-keeping and archiving (minimum retention periods)

Expand the 'Key provisions' section to include: "Clinical trial approval must be obtained from MFDS before trial initiation. Standard approval timeline is 30 days. An IRB/EC review and approval is also required in parallel with MFDS submission. Serious adverse events must be reported to MFDS within 15 days. Trial records must be retained for a minimum of 5 years after trial completion or device approval, whichever is later."