Primarily due to the pressing problem of doctor shortage, the Chinese government is eagerly encouraging medical use of Artificial Intelligence. Currently, China has two kinds of license for AI medical devices: One is assistive, which aids healthcare professionals in their provision of care, and the other is diagnostic: like the consultation room of the future, they act as a virtual doctor.
Since April 2018 when the FDA approved the first artificial intelligence-based device, to detect certain diabetes-related eye problems, NMPA has been very busy in preparing the regulatory establishments for AI devices.
Verification and validation
According to a consulting firm Marketing to China, the domestic market for AI medical devices reached 20 billion yuan ($2.95 billion) in 2018. Accelerated efforts from NMPA will definitely compel China to be the leader of AI applications.
For NMPA link for the draft guideline on AI-Aided Software (Draft), please email info@ChinaMedDevice.com. We charge nominal fees for the translation.
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ChinaMed Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for western medical device, IVD, CDx and combination products to enter China. As a certified NMPA (CFDA) legal agent with offices in Boston and Beijing, we can represent overseas manufacturers for the complete product life cycle without their need to set up local entity in China. Our NMPA (CFDA) regulatory services include: RA, regulatory strategy, regulatory submissions, clinical evaluation reports (CER), clinical trials, QA, GMP and post-market compliance. Our commercialization services include: market assessment research, reimbursement, partnership strategies, and distribution qualification.