The NMPA is Taking Actions for AI Device Registration and Applications

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.

Listed below are milestones reached

1. Medical Device Classification Catalog, effective on August 1, 2018, included AI diagnostics for the first time.
2. NMPA issued the Notices of Soliciting Manufacturers’ Opinion on November 19, 2018 for the Registration Guidelines for AI Medical Devices. Opinions are to be collected in the areas of “Workflow Optimization, Data Processing and Assisted Diagnosis”.
3. NMPA issued the Technical Review Guideline on AI-Aided Software (Draft) on February 1, 2019. The draft guideline lists four main considerations for registration:Need analysisData collectionAlgorithm designVerification and validation
4. NMPA established the AI Medical Device Standardization Unit on March 14, 2019. The Unit is to be responsible for standardization of terminology, classification, data set quality management, basic common technology, quality management system, product evaluation process, special evaluation methods for AI medical devices.
5. Considering that many manufacturers will go through the Innovation Pathway, NMPA is to publish the Technical Review Guideline on AI-Aided Software for Innovation Approval this year.

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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About ChinaMed Device, LLC 

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.