Clinical Trials in Korea

Registration requirement

Clinical trials must be registered in an MFDS-recognised registry before the first participant is enrolled:

• ClinicalTrials.gov
• CRIS — Korea's national clinical research registry

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