AI/ML-Based Medical Devices
Korea was among the first regulators globally to issue dedicated AI/ML medical device guidance (initial guidance 2017; updated 2021, 2024).
Classificationโ
Same SaMD grade criteria, with attention to:
- Whether AI output is used directly for clinical decisions (higher risk)
- Locked (static) vs adaptive (changing) algorithm
- Clinical consequence of an incorrect AI output
Key application requirements for ํ๋ชฉํ๊ฐโ
- Algorithm description and validation data
- Training data characteristics and representativeness
- Test dataset performance metrics
- Explainability / transparency documentation
- Post-market performance monitoring plan
Post-market monitoringโ
MFDS requires ongoing monitoring of AI algorithm performance after approval, including drift detection and planned re-validation when significant data shifts occur.