New and Draft MFDS Guidance
MFDS regularly publishes new guidance documents (κ°μ΄λλΌμΈ) and puts draft guidance out for public comment before finalisation.
How to stay currentβ
- Monitor the MFDS website notifications (κ³ μ) section for new publications
- Subscribe to MFDS email alerts (available to registered users of the MFDS portal)
- Check the MFDS public comment portal for draft guidance open for industry input
Recent guidance publications (illustrative)β
| Year | Document | Topic |
|---|---|---|
| 2024 | AI/ML Medical Device Guideline (revised) | Algorithm validation, PCCP, post-market monitoring |
| 2024 | Cybersecurity Guidance for Connected Devices | Cybersecurity requirements (initial release) |
| 2024 | DTx Regulatory Pathway Guidance | Digital therapeutics β criteria for regulatory oversight |
| 2023 | eIFU Implementation Guidance | Electronic IFU requirements and conditions |