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2026 China NMPA Bluebook is here:
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.
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
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
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
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 “2024 National Medical Device Clinical Evaluation Standards Project Proposals” on March 8, 2023, asking proposals by June 30, 2023. Those received thereafter
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
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 six draft clinical guidelines, for predicate-comparison, on October 25, 2022, soliciting public opinions. Your feedback needs to be submitted by November 21,
The NMPA issued the “Clinical Pathway Recommendations for Certain Categories of Medical Devices” on July 14, 2022. The document suggests manufacturers how to choose clinical
The NMPA published the draft version of “Clinical Trial Exemptions Catalog for Medical Devices” on July 5, 2022, for feedback. It is an effort to
NMPA issued the “Clinical Pathway Recommendations for Certain Categories of Medical Devices” on June 16, 2022. The document suggests manufacturers how to choose clinical evaluation