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2026 China NMPA Bluebook is here:
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
NMPA published the “Inspection Checkpoints and Judging Principles for Clinical Trial” for feedback. Feedback needs to be submitted by June 30, 2024. NMPA announced the
NMPA issued the clinical trial audit result for an IVD manufacturer on April 16, 2024. The audited firm is Guangdong Hexin. Its Respiratory Syncytial Virus,
“Quality Management Practice Specification for Clinical Trials of Medical Devices (so called China GCP)”, implemented from March 2022, specifies that “Clinical trial sites must be
NMPA announced the “Measures for Supervision and Inspection of Medical Device Clinical Trial Institutions (Trial)” on March 12, 2024, for feedback, along with the inspection
NMPA issued the “Clinical Pathway Recommendations for Certain Categories of Medical Devices” today on March 18, 2024. The document suggests manufacturers how to choose predicate
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
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
NMPA issued the “Key Points and Principles for Medical Device Clinical Trial Inspections (Draft) on November 28, 2023. Feedback needs to be submitted by December
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
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
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