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2024 China NMPA Bluebook is here:
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 AI-related guidelines released in 2023.
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 Detection Devices Applied to Radiology
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 Guidelines for AI Software The
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, clinical evaluation, and regulatory submission.
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 validation. Artificial intelligence software for
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 and industry leaders discussed artificial
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 Lei Sun, CMDE’s director, 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 regulatory submission. It is the
The NMPA is now seeking comments to the draft guidance “Artificial Intelligence Medical Software Classification ”, due by May 3, 2021. AI technologies have the potential to transform health care
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, a Hong Kong-based biotech magazine,
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 AI innovative product approved by
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