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2024 China NMPA Bluebook is here:

Feedbacks Needed for DR and Ultrasonic Diagnostic Software


The NMPA announced its preparation of “Technical Review Guideline of Diagnostic Software for Diabetic Retinopathy (DR)” and “Technical Review Guideline of Image Ultrasonic Diagnostic Based AI Software” for public comments on December 31, 2020. feedback needs to be submitted by Jan. 31, 2021.

It is a great opportunity to have your voices heard by NMPA reviewers and influence them to form a more practical guideline in the end. A thorough and realistic guidance document not only helps NMPA reviewers during their technical review process but also guides manufacturers to satisfy NMPA’s requirements. For more information about how to develop a feedback strategy or assistance in submitting your inputs, please contact

DR Software Approvals

The NMPA granted Innovation Approvals of two diabetic retinopathy assistant diagnosis software in August 2020. It is the first time that AI technology is approved for ophthalmology diagnosis in China.

The approvals are based on the neural network of the independent design network structure, through the classification of the fundus image data, the algorithm model training and verification. By obtaining color images of the fundus and using deep learning algorithm to calculate and analyze the images, the product draws the assistant diagnosis recommendations for DR, which are provided to qualified clinicians for diagnosis reference.

AI General Guideline & COVID Triage Guideline

Since April 2018 when the FDA approved the first AI software to detect diabetic retinopathy, NMPA has been busy in preparing the regulatory establishments for AI devices.

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

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

Under the Covid-19 pandemic, the 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.

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 soon.

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