Reforms Tracker
Active reform areasβ
| Reform | Status | Expected timeframe |
|---|---|---|
| UDI-K expansion to Grade I/II | In progress β Grade II next | 2025β2027 |
| Cybersecurity requirements for connected devices | Guidance published β binding requirements in development | 2025β2026 |
| PCCP framework for AI/ML SaMD | Draft guidance in development | 2025 |
| DTx (Digital Therapeutics) regulatory classification refinement | Ongoing | Ongoing |
| IVD classification alignment with WHO IVD framework | Under review | TBD |
| NHI streamlined listing for innovative devices | Policy announced | TBD |
How to participate in consultationβ
MFDS invites industry feedback on draft guidance:
- Monitor MFDS website for draft guidance (μ견 μ²μ·¨) announcements
- Submissions can be made via the MFDS portal or in writing to MFDS
- Industry associations (e.g., KMDIA β Korean Medical Device Industry Association) often coordinate industry responses