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2026 China NMPA Bluebook is here:
There have been 181 guidelines issued by the NMPA in 2022. The revised or newly established guidelines are aimed to facilitate manufacturers with local type
There have been 32 innovation approvals granted by the NMPA in 2022. Overseas manufacturer Medtronic, Ethicon and BioFire Diagnostics are on the list. Cardiovascular, gastro/urology,
Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in December 2022. These updates are presented by China
The NMPA released the “Review Key Points of Recombinant Human Collagen Injection Materials for Plastic Surgery (Draft)” on December 29, 2022, directing manufacturers on type
The NMPA released ninety-four review reports in 2022. Three categories of approvals are included: innovation, priority review and Class III predicate-comparison devices. Overseas manufacturers including
The NMPA granted innovation approvals to two radiology devices, used in combination for ultrasound imaging of intravascular lesions in coronary arteries. There have been 185
There have been 92 recalls from overseas manufacturers reported to the NMPA in 2022, as of December 21. Many big names are on the list.
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