AI Regulatory Developments and Planning Issued by China Regulator

On November 19, 2020, the Center for Medical Device Evaluation (CMDE) of the National Medical Products Administration (NMPA) published an article to give an overview of the regulatory developments and future plans for AI medical devices. We provide a brief summary as below.

Regulatory development

In 2017, the CMDE established the AI working group to:

• Learn about the regulatory control and product registration procedure for AI medical devices in other countries
• Knowledge sharing with related enterprises, research facilities and medical institutions to understand the AI product characteristics, technical specifications, risks for clinical use, etc.
• Compile a database of AI medical device manufacturers and their related information to follow up on the latest status of industry developments

The CMDE AI working group’s first research project focused on the safety and performance evaluation of three fast growing AI medical devices and the respective real-world data requirements for each product:

• Diabetic retinopathy auxiliary diagnostic products
• CT pulmonary nodule auxiliary diagnosis products
• Pathological image artificial intelligence analysis software

In July 2019, the “Key Points for Deep Learning Aided Decision-Making Medical Device Software Review” was published.

In March 2020, the “Key Points for Evaluation of Pneumonia CT Image Triage and Evaluation Software (Trial)” was published.

In August 2020, two innovative products utilizing AI technology in the field of auxiliary diagnosis of diabetic retinopathy obtained the fast-track approval to enter the China market.

On December 3, 2020, the CMDE announced the plan to implement the “Key Points for the Performance Evaluation of AI Analysis Software for Blood Disease Flow Cytology”. The CMDE is currently asking for feedback from the related manufacturers. The period of consultation lasts until December 31, 2020. Feel free to let us know if you would like to submit a strong proposal together with Cisema.

With more experience gained from the product evaluation process and granting market approvals to more and more AI medical devices in China, the CMDE’s next plan is to implement the technical review guidelines for AI medical devices by 2021.

By Jacky Li. Contact Cisema if you would like to learn more.