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In One Day, Two AI Diagnostic Software Go into NMPA Fast-Track Channel


NMPA granted fast-track channel status to two domestic AI-infused software on June 29, 2020:

Innovation Status

  • Zhiyuan Huitu: Assistance software for fundus diagnosis

Priority Review Status

  • Hangzhou Yitu: Assistance software for children bone age diagnosis

Two AI Device Categories

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,
  • The other is diagnostic, like the consultation room of the future, they act as a virtual doctor.

The above software falls into the former category.

Since April 2018 when the FDA approved the first artificial intelligence-based device, to detect certain diabetes-related eye problems, NMPA has been busy in preparing the regulatory establishments for AI devices.

There is no overseas AI software approved by NMPA.

AI General Guideline & COVID Triage Guideline

NMPA issued the “Technical Guideline on AI-Aided Software” on June 28, 2019. The guideline lists four focal considerations in NMPA review process:

  • Needs analysis
  • Data collection
  • Algorithm design
  • Verification and validation

Under the Covid-19 pandemic, NMPA published the “Review Points of CT Image-Assisted Triage and Evaluation Software for Covid-19 Infected Pneumonia” on March 5, 2020. The document provides guidance to AI software manufacturers on the application scope, basic requirements, risk management, software research, clinical research, and software renewal.

For our review of the AI-aided software guideline, please click HERE. For Covid-19 triage software guideline, click HERE.

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 compel China to be the leader of AI applications.

For an English copy of the guideline on AI-Aided Software, please email We charge nominal fees for the translation.

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