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2026 China NMPA Bluebook is here:
69 high-risk class III devices were included in the Unique Device Identification (UDI) application of First Group of Devices, which started from January 1, 2021.
The DeneB hyaluronic acid, manufactured by South Korea’s BioPlus, completed the first injection in Hainan Lecheng Hospital on November 29, bringing advanced medical beauty solutions
The NMPA issued seven IVDs draft guidelines on December 2, 2022, soliciting public opinions. Feedbacks need to be submitted by December 16, 2022. Draft Guideline
Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in November 2022. These updates are presented by China
NMPA issued the “Checkpoints of Common Violations of Regulations in the Production, Supply and Usage of Medical Cosmetic Devices” on November 25, 2022. It asks
The NMPA issued the “list of mandatory standards applicable to medicals” on November 11, 2022, directing manufacturers for type testing and regulatory submission. Over 400
The NMPA issued a notice “Information Solicitation on New Materials and Product Performance Evaluation for Biological 3D Printing”. It says domestic and foreign enterprises, scientific
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 NMPA granted innovation approval to Boston Scientific for the Sentinel Cerebral Protection System on November 2, 2022. The device belongs to “first-of-its-kind in China”
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
Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in October 2022. These updates are presented by China
The NMPA issued five IVD draft guidelines on October 1, 2022, soliciting public opinions. Feedbacks need to be submitted by October 22, 2022. Full List