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2023 China NMPA Bluebook is here:
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,
The Hong Kong Department of Health has implemented a new medical device procurement policy, effective from June 21, 2023. The policy prioritizes Medical Device Administrative Control System (MDACS)-listed medical devices,
China’s Greater Bay Area is one of the most affluent and populated regions with close to 86.17M people, more than the entire size of Germany. To sell in GBA Hong
The NMPA published three new clinical guidelines on August 6, 2023, to direct manufacturers for local type testing, pre-clinical, clinical studies, and regulatory submissions. Three New Published Clinical Guidelines To
The NMPA published the final version of “Clinical Evaluation Exempt Catalog for Medical Devices” on July 20, 2023, which includes 2025 medical devices. Implementing risk-based clinical evaluation, the catalog will
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
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 Genetic Resources Management Regulations” effective
The NMPA issued “2024 National Medical Device Clinical Evaluation Standards Project Proposals” on March 8, 2023, asking proposals by June 30, 2023. Those received thereafter were deferred to the following
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 issued six draft clinical guidelines, for predicate-comparison, on October 25, 2022, soliciting public opinions. Your feedback needs to be submitted by November 21, 2022. View our service page
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