Digital Health and AI Policy Updates
Korea is recognized as a global leader in digital health and AI medical device regulation. The MFDS Digital Health Department has established a dedicated regulatory framework with dedicated guidance documents covering SaMD, AI/ML algorithms, Digital Therapeutics (DTx), and cybersecurity for connected devices.
Recent developments
| Year | Development |
|---|---|
| 2024 | AI/ML Medical Device Guideline revised — PCCP framework and post-market monitoring |
| 2024 | Digital Therapeutics (DTx) regulatory pathway clarified |
| 2024 | Cybersecurity guidance for connected devices released (initial version) |
| 2023 | Sandbox regulatory program for DTx expanded |
| 2022 | MFDS Digital Health Department formally established |
Upcoming developments
- MFDS is expected to issue a comprehensive cybersecurity standard for connected medical devices
- PCCP (Predetermined Change Control Plan) guidance for AI/ML devices in development
- Alignment with IMDRF SaMD post-market monitoring framework expected