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 and changes
All protocol amendments—including changes to objectives, design, endpoints, investigational device specifications, or risk management—must be submitted to both MFDS and the IRB for approval before implementation.
Amendments may be subject to a simplified or expedited review process if the change is:
- Administrative or minor labelling corrections
- Clarifications that do not affect scientific integrity
- Safety improvements with no increased risk
Major amendments (e.g., new endpoints, significant design changes, additional sites) require full review by both MFDS and IRB.
The 30 working day timeline begins after MFDS completes its initial completeness check of the application. If the application is found incomplete during this check, MFDS will issue a 보충요청 (request for additional information), and the review clock stops until a complete response is received. Applicants are typically given 60–90 days to submit responses.
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.