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IRB and GCP Requirements

IRB (μž„μƒμ‹œν—˜μ‹¬μ‚¬μœ„μ›νšŒ)​

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 (생λͺ…μœ€λ¦¬ 및 μ•ˆμ „μ— κ΄€ν•œ 법λ₯ ).

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 β€” 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 β€” GCP standards for medical device clinical trials