SFDA MDS-G010MDS-G010
MDS-G010 is the official SFDA identifier for “Guidance on Artificial Intelligence (AI) and Machine Learning (ML) Technologies Based Medical Devices”. MDS-G010 is the official identifier SFDA uses for this instrument.
- Instrument
- MDS-G010
- Full name
- MDS-G010
- Category
- Software/SaMD
- Authority source
- English
- Readable HTML
- 0 articles · 1 language version
- Published
- 3 January 2023
- Effective
- January 2023
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Each version has stable article anchors for direct citations and highlighting. The readable text is generated from an authority source and does not replace the legally controlling publication.
Guidance on Artificial Intelligence (AI) and Machine Learning (ML) Technologies Based Medical Devices
MDS-G010 Version 1.0 (3 January 2023): regulatory requirements for obtaining marketing authorization for AI/ML-based medical devices that diagnose, manage, or predict diseases by analyzing medical data — classification criteria, intended use, clinical evaluation, risk management, quality management systems, and change notification (major vs. minor changes with documentation), plus definitions and further reading. Title corrected to the official cover.
MDS-G010 is the official identifier SFDA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.