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2026 China NMPA Bluebook is here:
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 NMPA published an article on artificial intelligence software for process optimization, illustrating what the clinical applications of the software and how to do software
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
NMPA issued the “Artificial Intelligence Medical Software Classification Guideline” on July 8, 2021, to direct manufacturers for the classification and the corresponding clinical data and
The NMPA is now seeking comments to the draft guidance “Artificial Intelligence Medical Software Classification ”, due by May 3, 2021. AI technologies have the
The article below provides comprehensive technical review on AI-aided Software Guideline, released in June 2019. It was written by Elisa Mark and published on BioWorld,
NMPA granted Innovative Device Approval to the CT Imaging Assisted Pulmonary Nodule Detection Software produced by Hangzhou Deepwise on December 1, 2020. This is the second