Call for Comments on the Proposed Document 'Guidance on Pre-market submission requirement for artificial intelligence/machine learning based computer-assisted detection (CADe) and computer-assisted diagnosis (CADx) software as a medical device'

2 Sep 2025 | Announcements

For your kind perusal, please find attached the WG3 Proposed Document 'Guidance on Pre-market submission requirement for artificial intelligence/machine learning based computer-assisted detection (CADe) and computer-assisted diagnosis (CADx) software as a medical device'.

Kindly send your comments with the template attached to the GHWP Secretariat (secretariat@ghwp.info) on or before 27 October 2025 (Monday) 12:00noon (GMT+8). Thank you.

Guidance on Pre-market submission requirement for artificial intelligence/machine learning based computer-assisted detection (CADe) and computer-assisted diagnosis (CADx) software as a medical device

GHWP Comment Submission Form

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