Recent Amendments and Upcoming Changes
Significant recent amendments
| Year | Amendment | Impact |
|---|---|---|
| 2019 | IVD Act enacted | Separate regulation for IVDs established |
| 2021 | IVD Act fully effective | All IVD manufacturers transition |
| 2022 | UDI-K Phase 1 | Grade IV devices require UDI-K labelling and KIMS registration |
| 2023 | Innovative Medical Device scheme expanded | Faster review for devices meeting innovation criteria |
| 2024 | AI/ML guidance updated | New requirements for post-market performance monitoring |
| 2024 | eIFU provisions introduced | Electronic IFU permitted for professional-use devices |
| 2024 | UDI-K Phase 2 | Grade III devices require UDI-K |
Where to find current amendments
- MFDS website — notifications (고시) database
- law.go.kr — for Acts and Decrees
- What's New — Reforms tracker
For the 2024 AI/ML guidance update entry, add: 'Includes mandatory algorithm change monitoring protocol (ACMP), explainability documentation for high-risk algorithms, and requirements for clinician notification of significant algorithm modifications.'