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2026 China NMPA Bluebook is here:
The NMPA published 20 industry standards on June 28, 2023, to guide manufacturers for local type testing, pre-clinical, clinical studies, and regulatory submissions. Significance of
The NMPA published 20 industry standards on June 28, 2023, to guide manufacturers for local type testing, pre-clinical, clinical studies, and regulatory submissions. Significance of
Allurion’s weight loss gastric balloon completed the first implantation in China at Hainan Ruijin Hospital on June 27, 2023. Overweight patients with a body mass
Allurion’s weight loss gastric balloon completed the first implantation in China at Hainan Ruijin Hospital on June 27, 2023. Overweight patients with a body mass
The NMPA granted innovation approvals to two devices on June 20, 2023. There have been 217 innovation devices approved since 2014. To get an English
The NMPA issued the “Guidance on Application Materials for Classification of Medical Devices” on June 14, 2023. It is applicable to both domestic and overseas
On May 16, 2023, the NMPA granted innovation approval to Corindus Inc., for its interventional coronary surgical control system accessories. It is the fifth imported
China’s Ministry of Science and Technology published the “Details for the Implementation of the Human Genetic Resources Regulations” on June 1, 2023. Based on “Human
The NMPA issued the “Draft Guideline on Modification Registration IVD of In Vitro Diagnostic Reagent” on May 31, 2023, for feedback. Feedbacks need to be
Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in May 2023. These updates are presented by China
The NMPA issued “Guideline on Recombinant Humanized Collagen Raw Materials” and “Guideline on Recombinant Collagen Wound Dressings” on May 23, 2023. The two guidelines are
The NMPA issued the final document of “2023 Medical Device Industry Standards Revisions Plan” on May 24, two weeks after the release of draft version.