Clinical Trial Device (임상시험용 의료기기)
An investigational device (임상시험용 의료기기) is a device used in a clinical trial that has not yet received 품목허가 in Korea.
Regulatory requirements
- The device must have MFDS clinical trial approval (임상시험 승인) before being used
- The device must be labelled: "임상시험용 의료기기" (Investigational Device)
- The manufacturer must maintain appropriate quality controls during manufacture of investigational devices (not a full KGMP certification required, but controlled manufacturing)
- Distribution is restricted to approved trial sites only
Supply to clinical sites
The investigational device may be supplied free of charge to trial sites — commercial supply before 품목허가 is prohibited.
Record-keeping
Full manufacturing and distribution records must be maintained for all investigational devices, including lot numbers, quantities, and site distribution.