Recent Legislative Changes and Timeline
| Year | Change | Impact |
|---|---|---|
| 2019 | IVD Act enacted | Separate regulation for IVDs established; effective May 2021 |
| 2021 | IVD Act fully effective | All IVD manufacturers transition from Medical Devices Act |
| 2022 | UDI-K Phase 1 | Grade IV devices require UDI-K labelling and KIMS registration |
| 2023 | Innovative Medical Device scheme expanded | Faster pathway for innovative devices |
| 2024 | AI/ML guidance updated | Post-market performance monitoring requirements for AI algorithms |
| 2024 | eIFU provisions introduced | Electronic IFU permitted for professional-use devices |
| 2024 | UDI-K Phase 2 | Grade III devices require UDI-K |
Stay current
See What's New for the latest updates.
In the 2021 row, change 'Year' column from '2021' to '2021 (May)' to align with the stated 'May 2021' effective date mentioned elsewhere on the site