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AI Device Clinical Evaluation Guideline and Seven Others to be Released Soon


The committee meeting of the China Artificial Intelligence Medical Device Innovation Cooperation Platform was held online on September 21, 2022.

Focusing on bio-digital integration, experts and industry leaders discussed artificial intelligence technology in the fields of brain-computer interface, wearable devices, bioartificial organs innovative application model of medical devices, evaluation tools for the safety and effectiveness of software and hardware infrastructure, interactive feedback, processing algorithms, and personalized diagnosis and treatment.

The following guidelines are to be published in 2023:

  • Clinical evaluation of deep learning medical devices
  • Method for identification and assessment of cybersecurity vulnerabilities in medical devices
  • 5G-based ultrasonic diagnostic system technical requirements and test methods
  • Technical requirements and test methods of 5G-based robotic interventional diagnosis and treatment system
  • Technical requirements and test methods for 5G-based remote robot-assisted surgery: laparoscopic surgical robot
  • 5G-based telemedicine private network technical requirements and test methods
  • Cervical cytopathological image standard database data standard system
  • Medical artificial intelligence technology terms

The China Artificial Intelligence Medical Device Innovation Cooperation Platform has 17 branches as shown below. They summarized their work in 2022.

  • Technical regulations
  • Data governance
  • Evaluation database construction
  • Cyber security
  • Standardized Research
  • Evaluation Technology Research
  • Clinical evaluation
  • Real world data applications
  • Talent development
  • International exchange
  • Research on Medical Data Application Technology
  • Medical artificial intelligence terminology normalization
  • Intelligent medical device core components
  • In-depth research on high-end medical equipment
  • Research on the new generation of wireless diagnosis and treatment application technology
  • Research on the development of intelligent medical device industry
  • Evaluation of artificial intelligence medical imaging diagnosis and treatment technology

View our Guideline on Artificial Intelligence Medical Devices (Draft)

View our Technical Guideline on AI-Aided Software

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