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2025 China NMPA Bluebook is here:
NMPA Center for Food and Drug Inspection released the “Key Points for the Inspection of Real-World Studies on Medical Devices (Draft)” for feedback on December 27, 2024. Feedback needs to
The Greater Bay Area (GBA) – with a total population of approximately 71.2 million people (5% of China’s total population) – includes nine mega cities of Guangdong province: Guangzhou, Shenzhen,
NMPA published the finalized document “Guideline on Medical Device Real-world Study Design and Statistical Analysis” on January 15, 2024. The draft version was released on September 28, 2023. Significance of
Hainan government issued the “Administrative Measures of Clinically Urgent Imported Drugs and Medical Devices Taken Out of the Hospital in Hainan Free Trade Port Boao Lecheng International Medical Tourism Pilot
Picture: Grace Palma, CEO of China Med Device, LLC in RWD workshop in Hainan The NMPA published the “Guideline on Medical Device Real World Study Design Statistical Analysis (Draft)” today,
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 index (BMI) greater than 27
Hainan government released the “Regulations on the Administration of Urgent Use Imported Drugs and Medical Devices in the Boao Lecheng International Medical Tourism Pilot Zone of Hainan Free Trade Port”
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 published 33 review reports from January to April 2022. Three categories are included: innovation, priority review and Class III predicate-comparison devices. Overseas manufacturers including Boston Scientific, Edwards Lifesciences
Hainan Boao special zone allows overseas unapproved medical devices, IVDs, drugs in China to be used. In addition to the overseas medical products being sold and commercialized faster through this
Hainan Lecheng Boao International Medical Pilot District released “Pilot Trials of International Innovative Neurological Products” on March 29, 2022, to solicit imported products from neurological device manufacturers, research institutions and
The NMPA granted approvals to two devices, Boston Scientific’s Rezūm Water Vapor Therapy equipment, and its disposable prostate treatment accessory on March 3, 2022. It only took four months for
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