I'm interested in AI/SaMD products China-inbound, so I thought I'd share some recent regulatory news - happy to keep doing so if others find this useful.
- "Key Points for Evaluation and Evaluation of the Performance of Artificial Intelligence Analysis Software for Blood Disease Flow Cytology" (December 3, 2020), see here.
- NMPA article on "The Orderly Development of AI medical device safety and effectiveness evaluation research" (November 17, 2020), see here.
Both are available only in Chinese but Google Translate works well to give the gist of each.
Regarding the Cytology guidelines (point 1), from what we're seeing the regulator is working hard to develop a framework that accommodates the regulatory difficulties of a product where input/output is non-linear as against the fundamental requirements of safety and efficacy. NMPA is asking for industry feedback by December 31. If you are interested in doing so, please let us know.
The article (point 2 above) walks through some recent history about the Chinese regulatory approach to AI in healthcare: a working group was established in 2017; release of "Key Points for Deep Learning Aided Decision-Making Medical Device Software Review" in July 2019; release of "Key Points for Evaluation of Pneumonia CT Image Triage and Evaluation Software (Trial)" in March 2020; and inclusion in the innovative approval channel for two products in the field of auxiliary diagnosis of diabetic retinopathy in August this year.
The article states that 3 fast-growing product areas are targeted as the regulator develops the regulatory framework: diabetic retinopathy auxiliary diagnostic products, CT pulmonary nodule auxiliary diagnosis products and pathological image artificial intelligence analysis software.
That the article was written shows the importance with which the topic is viewed in the country, and gives some insight into the regulator's current thinking.
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Hamish King
Director Business Development
Hong Kong
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