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Clinical Trials in Korea

Registration requirement​

Clinical trials should be registered in an MFDS-recognised registry such as ClinicalTrials.gov or CRIS, typically before the first participant is enrolled, though registration can occur within 30 days of enrollment start:

Investigational device labelling​

Must be labelled: "임상시험용 의료기기 (Investigational Device)"

Trial types (device-specific)​

  • Feasibility study — early-phase safety and signal-finding
  • Pivotal trial — primary evidence base for 품목허가

Post-trial obligations​

  • Submit trial completion report to MFDS
  • Report outstanding serious adverse events
  • Retain data/records for the minimum period specified by MFDS regulations

Late registration may be flagged during MFDS review or post-market inspections. Registration should be prioritized before or immediately upon enrollment of the first participant to ensure compliance with MFDS expectations and international best practices.