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Risk Management (ISO 14971)

Korea requires ISO 14971 risk management for all Grade III and IV devices (and IVD Grades C/D).

Required documentation​

  • Risk management plan
  • Hazard identification and risk estimation
  • Risk control measures and verification
  • Residual risk evaluation
  • Benefit-risk analysis and conclusions
  • Risk management report summary (included in STED)

What MFDS reviewers look for​

  • Systematic and thorough hazard identification
  • Genuine root-cause-based risk controls
  • Acceptable residual risks given intended use and patient population
  • Clear benefit-risk justification for the claimed indications

Relevant standards​

  • ISO 14971:2019 — Risk management for medical devices
  • ISO/TR 24971 — Guidance on application of ISO 14971

While formal ISO 14971 documentation is mandated for Grade III/IV and IVD Grades C/D devices, Grade I and II devices must still address risk management principles, though documentation may be less formal. MFDS expects evidence that hazards have been identified and residual risks are acceptable, even if a complete ISO 14971 report is not required.