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IRB and GCP Requirements

IRB (임상시험심사위원회)​

Every clinical trial site in Korea must have IRB approval before the trial begins at that site. Multi-site trials require approval from each site's IRB. Korean IRBs operate under the Medical Devices Act Enforcement Rules and the Bioethics and Safety Act (생명윤리 및 안전에 관한 법률).

Korean GCP (ISO 14155 aligned)​

MFDS GCP for medical device clinical trials is aligned with ISO 14155:

  • Written informed consent from all participants
  • Data integrity — accurate, complete, traceable records
  • Safety monitoring committee for high-risk devices
  • Serious adverse event reporting during the trial
  • Site audits possible

Relevant legislation​

  • Medical Devices Act, Articles 10–12
  • MFDS Notification — GCP standards for medical device clinical trials

Korean IRBs reviewing medical device trials must include at least one member with medical device expertise. Standard IRB composition requirements under the Bioethics and Safety Act apply, including lay members and community representatives.