Category: AI

The NMPA released the “Draft Guideline on Artificial Intelligence Medical Devices” and “Draft Guideline on Clinical Evaluation of Artificial Intelligence Multi-Disease Auxiliary Decision-Making Medical Device”

NMPA issued the “Technical Review Key Points for Implanted BCI Motor Function Compensation Device (Draft)” on August 18, 2026. This document is for premarket review

NMPA released the “Draft Guideline on Clinical Evaluation of AI-Assisted Diagnostic Medical Devices” on June 17, 2026. Feedbacks need to be submitted by July 10,

AI Guidelines 2023 The NMPA (National Medical Products Administration) affiliated Artificial Intelligence Medical Device Innovation Cooperation Platform has provided a comprehensive summary of six pivotal

NMPA released the “Clinical Evaluation Guideline on Artificial Intelligence-assisted Detection Medical Devices (Software)” on November 7, 2023. The guideline refers to FDA guidance of “Computer-Assisted

The NMPA published four guidelines for AI software on July 10, 2023, propelling China to be the leader in the AI applications. Full List of

The NMPA published the “Key Points of Ultrasound Imaging Artificial Intelligence Software (Process Optimization)” on July 10, 2023, to direct related manufacturers for type testing,

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

The article below is written by Liang Peng, AI expert and Deputy Minister of Evaluation Department I of CMDE (Center for Medical Device Evaluation) and