China standardizes registration and evaluation of AI devices

As China pushes the development and use artificial intelligence to ease its chronic shortages of doctors and healthcare facilities, it is moving rapidly to lay down a regulatory framework for the emerging field.

In March, China’s National Medical Products Administration established a separate unit tasked with standardizing a product evaluation process for AI medical devices. That followed the inclusion for the first time last August of AI diagnostic devices in the Medical Device Classification Catalog published by NMPA. The Administration has also moved to establish guidelines for registering AI medical devices and AI-aided software.