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2025 China NMPA Bluebook is here:
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The NMPA is now seeking comments to the draft guidance “Artificial Intelligence Medical Software Classification ”, due by May 3, 2021.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,
The NMPA officially published the first guideline specifically for CDx reagents, the “Guideline for Technical Review and IFU Update for Oncology CDx Based on the Same Group of Therapeutic Drugs”
China NMPA moves fast to provide more details in support of the State Council “Regulation on the Supervision and Administration of Medical Devices”, to support Order 739. Four supporting regulations
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
The NMPA published twelve guidelines on December 9, 2020. Among all the guidelines, seven of them are for IVD products and five are for nomenclature. The guidelines were put in