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:
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Key points of technical review of imaging ultrasound artificial intelligence software (process optimization functions).
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Review points for performance evaluation of pathological image artificial intelligence analysis software.
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Key points of clinical evaluation and review of pathological image artificial intelligence analysis software.
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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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