Clinical Trials in Korea
Registration requirementβ
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:
- ClinicalTrials.gov
- CRIS β Korea's national clinical research registry
Investigational device labellingβ
Must be labelled: "μμμνμ© μλ£κΈ°κΈ° (Investigational Device)"
Trial types (device-specific)β
- Feasibility study β early-phase safety and signal-finding
- Pivotal trial β primary evidence base for νλͺ©νκ°
Post-trial obligationsβ
- Submit trial completion report to MFDS
- Report outstanding serious adverse events
- Retain data/records for the minimum period specified by MFDS regulations