Register for Upcoming Webinar on DEC. 8 @ 11AM

2023 China NMPA Bluebook is here:

Forty-Eight AI Software Approved So Far, with Eight AI Guidelines Issued


48 AI independent software have been approved so far, according to work summary of Artificial Intelligence Medical Device Innovation Cooperation Platform that NMPA CMDE established in July 2019.

The notice says that data types of approved software cover a variety of fields: imaging, physiological information, and in vitro diagnostics, etc.; Product types cover auxiliary diagnosis, auxiliary testing, auxiliary triage, and assessment. Also, 14 independent software entered the innovation channel, including CT imaging, fundus photography of diabetic retinopathy, digestive endoscopic assisted diagnosis, and surgical planning assistance.

Check out the latest approvals of AI software

Or view the NMPA chief reviewers’ opinion on regulating AI medical devices

AI Independent Software NMPA Guidelines

8 review guidelines and review points have been released. Among them,

At present, there are additional 61 standards and technical documents formulated by the platform, some of which were already released.

Databases & Working Groups

The databases built by the platform cover multiple data fields such as fundus photography, pneumonia CT, thyroid ultrasound, etc., which help the development and market approval of AI medical products. There are also databases under construction, such as pathological images of cervical cells and multimodal images of pathological myopia.

  • Data Governance Group: data-quality-control-focused study of process, methods and requirements of data governance of AI medical devices.
  • Real-World Data Group: use the methodological research to guide the databases, which are used to support product R&D training and performance verification.
  • Evaluation technology Group: responsible for quality control and product verification, studies data quality requirements and product evaluation methods.
  • Clinical Evaluation Group: research on supplementation of clinical evaluation data to reduce or replace some clinical trial.

Have Questions?

Related Services


Recent Events

Related Posts


Get Updated

Receive Updates in Your Inbox