Recent Legislative Changes and Timeline
| Year | Change | Impact |
|---|---|---|
| 2019 | IVD Act enacted | Separate regulation for IVDs established; effective May 2021 |
| 2021 (May) | 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 |
| 2025 | Medical Devices Act amended (30 Dec 2025) | Legal basis for QMS Conformity Recognition Scheme; effective 1 July 2026 |
| 2026 | MFDS device review regulation revised (eff. 26 Jan 2026) | Expanded clinical evidence requirements, cybersecurity submission basis, SaMD/AI definitions, notarization requirement removed |
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