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The NMPA issued the “Guideline on Instructions for Use of In Vitro Diagnostic Reagents (draft)” for feedback. The guideline stipulates drug information such as the intended use, test methods, interpretation
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
The NMPA released three guidelines in a single day, March 9, 2022 in an effort to regulate and support the rapid development in digital health: Guideline for Artificial Intelligence in
The NMPA released the “Registration Guideline on Combination Products with Device as Primary Mode of Action” on January 11, 2022, directing manufacturers for safety and efficacy evaluation of combination products.
The NMPA Standards Management Center published the “First Batch of Combination Products Classification Results in 2021” on July 7. Worth noted that overseas manufacturers pay more attention to the combination
Manufacturers have long been concerned that when applying for drug-device combination product registration, in addition to original country approval for the combination product, the submission of certificates of the drug,
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The NMPA is now seeking comments to the draft guidance “Artificial Intelligence Medical Software Classification ”, due by May 3, 2021.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
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