最新消息

TAIWAN: Product Registration Guidance for Artificial Intelligence/Machine Learning-Based Computer-assisted Detection (CADe) and Diagnosis (CADx) Software – October/November 2022

TAIWAN: Product Registration Guidance for Artificial Intelligence/Machine Learning-Based Computer-assisted Detection (CADe) and Diagnosis (CADx) Software – October/November 2022

  • 2022-10-24 09:56:11

TFDA has recently announced a specific product registration guidance for AI/ML-based computer-assisted detection (CADe) and computer-assisted diagnosis (CADx) software. Through the application of AI and ML-based technologies in detective or diagnostic medical devices, these kinds of products could be essential for medical personnel by decreasing required reading time with better diagnostic performance.

了解更多