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MFDS Digital Health Framework

MFDS has developed a comprehensive Digital Health Regulatory Framework covering the full spectrum of digital health products from unregulated wellness apps to high-risk AI diagnostic systems.

Framework overview​

Digital health products
├── General wellness apps → NOT regulated as medical devices
├── Software as a Medical Device (SaMD) → Medical Devices Act (Grade I–IV)
├── AI/ML-based medical devices → Medical Devices Act (Grade II–IV typically)
├── Digital Therapeutics (DTx) → Medical Devices Act or regulatory sandbox
├── Connected device platforms → Medical Devices Act (if SaMD criteria met)
└── Mobile medical apps → Medical Devices Act (if SaMD criteria met)

Key guidance documents​

  • SaMD Classification Guideline — when software is a medical device
  • AI/ML Medical Device Guideline — validation and post-market requirements
  • DTx Regulatory Guidance — criteria for digital therapeutics oversight
  • Cybersecurity Guidance — requirements for connected medical devices

Korea's global position​

Korea is recognised as a global leader in digital health regulation, having issued AI/ML guidance earlier than the FDA or EMA. MFDS actively participates in IMDRF SaMD and AI/ML working groups.