Register for Upcoming Webinar on DEC. 8 @ 11AM

2023 China NMPA Bluebook is here:

AI Industry Pushing Forward, Mandated by China State Council


China State Council published an article on AI medical device on July 9th, aiming to propel China to the leadership of AI devices, especially AI-infused imaging diagnostics for eyes, lungs and chest.

China State Council quoted the data from Beijing Commission of Economy and Information Technology that the domestic market for AI medical devices reached 13 billion yuan ($1.95 billion) in 2017, a year-on-year increase of 40.7 percent.

It is expected that the market value of AI medical device will exceed 20 billion yuan by the end of this year, accounting for roughly one-fifth of global AI industry.

China State Council quoted Sun Lei, head of the CFDA Center for Medical Device Evaluation (CMDE), that the applications for such devices will continue to soar next year. “We project a similar trajectory for AI-the number of applications will increase a year after a fledgling technology becomes a hot spot for investment and news headlines”.


For regulatory and commercialization services on China AI market, please email


Sun further explained the regulatory pathway that “we (CMDE) must issue an initial report within 90 working days after the application is received, but it’s common that companies are required to provide more supporting materials or clinical data after their first-round trial.”

While CMDE’s primary concern is market approval, they recently formed a team to create a regulatory framework, including clinical trial guideline and technical review guideline, for AI medical devices, said He Weigang, a division director. They also closely work with the developers, researchers and physicians to draw the blueprint of the industry.


For the China State Council article, click HERE.

Keep yourself updated with CFDA News Roundup, click HERE to opt-in. For market access newsletter, click HERE. For CRO services in China, click HERE.


About China Med Device, LLC

China Med Device, LLC provides turn-key solutions for western medical device/IVD companies to enter China with regulation and commercialization services. Our CFDA regulatory services cover strategy, premarket submission, clinical evaluation, CRO, QA and post market compliance. We are certified as legal agent. Our commercial services cover market assessment research, reimbursement, partnership, distribution qualification and management. We have offices in Beijing, Suzhou and Boston. Our management team has 100+ years of combined experience in medical device and IVD and has been involved with 1,000+ CFDA certificates and 200+ companies’ success.

Have Questions?

Related Services


Recent Events

Related Posts


Get Updated

Receive Updates in Your Inbox