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2024 China NMPA Bluebook is here:
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 test, preclinical testing, clinical evaluation,
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 Boston Scientific, Edwards Lifesciences, Uptake
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 innovation devices approved since 2014.
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. Abbott, bioMerieux, Biomet, BD, Medtronic,
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. After that, UDI has been
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 to domestic beauty lovers. What’s
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 on Submission Materials of Blood
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 Med Device, your partner in
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 local NMPA offices to strengthen
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 mandatory national and industry standards
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 research institutes, clinical institutions, etc.
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
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