Recent Regulatory Changes
This page tracks recent and upcoming changes to Korean medical device regulation.
2024–2025 key changes
| Date | Change | Impact |
|---|---|---|
| 2024 | AI/ML medical device guidance updated | New post-market performance monitoring requirements for AI algorithm performance |
| 2024 | Electronic IFU (eIFU) provisions introduced | Professional-use devices may use eIFU in lieu of paper IFU |
| 2024 | UDI-K Phase 2 — Grade III | All Grade III devices require UDI-K labelling and KIMS registration |
| 2024 | MFDS digital health framework refresh | Updated scope of SaMD, DTx, and cybersecurity guidance |
| 2023 | Innovative Medical Device designation expanded | Expanded list of qualifying criteria and faster review pathway |
| 2023 | HIRA New Technology Assessment reform | Streamlined assessment process for novel medical devices |
2021–2023 key changes
| Date | Change |
|---|---|
| 2022 | UDI-K Phase 1 — Grade IV implemented |
| 2021 | IVD Act fully effective — separate IVD regulation operational |
| 2021 | KGMP for IVDs — dedicated IVD GMP requirements in force |
Auto-monitored
Check MFDS website for the most current updates — this page is updated periodically.