On July 10, 2023, the NMPA published a Notice introducing four key points that significantly influence the evaluation and regulation of artificial intelligence (AI) software in medical devices.
The release aims to standardize the management of AI-related medical products. Specifically, it includes the following key points:
Key points of technical review of imaging ultrasound artificial intelligence software (process optimization functions).
Review points for performance evaluation of pathological image artificial intelligence analysis software.
Key points of clinical evaluation and review of pathological image artificial intelligence analysis software.
Review key points for performance evaluation of artificial intelligence analysis software for blood disease flow cytometry.
Full resource available HERE. An English translation is available.
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