Digital Health and AI Policy Updates
Korea is one of the global leaders in digital health and AI medical device regulation. MFDS has been proactive in issuing dedicated guidance in this area.
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