| 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 |