Clinical Trial Approval (임상시험승인)
To conduct a clinical trial for an unapproved device (or new indication) in Korea, MFDS approval is required before the trial begins.
Application requirements
| Document | Notes |
|---|---|
| Clinical trial protocol (임상시험 계획서) | Objectives, design, endpoints |
| Investigational device dossier | Technical documentation |
| IRB approval letter | From Korean IRB |
| Investigator CVs | Principal and co-investigators |
| Informed consent form draft | Per Korean GCP |
| Risk management summary | ISO 14971 assessment |
Timeline
MFDS reviews clinical trial applications within approximately 30 working days.
IRB requirement
Both MFDS approval and IRB approval are required before the trial begins. Submit to both simultaneously; do not begin until both are received.
Related pages
Protocol amendments must be submitted to both MFDS and IRB for approval before implementation. Amendments may be subject to a simplified review process depending on the nature of the change. Clarify that the 30 working day timeline begins after completeness check.