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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.

Clinical trial approval process ​ The 임상시험 승인 (clinical trial approval) application must include: — Investigator's Brochure (IB) or Summary of Product Characteristics — Risk management plan and safety information — Quality/manufacturing information (CMC) — Clinical trial protocol and statistical analysis plan — Curriculum vitae of principal investigator(s) — Insurance or compensation information

Typical approval timeline: 30 days from receipt of complete application (may be extended for safety assessment)