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2026 China NMPA Bluebook is here:
The NMPA published its revised “Good Manufacturing Practice Specification for Medical Device Production” on November 4, 2025, a major update to the original 2014 regulation.
Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros. These updates are presented by China Med Device, LLC, your
NMPA released the industry standard “Test method for sensing and feedback performance of the interactive neurostimulator for medical equipment using brain-computer interface technology” on September
NMPA published the document “Guideline on Self-Testing for Medical Device Registration” on September 16, 2025. The draft version was released on June 26, 2025 for
The NMPA published the “Quality Management Regulation on Online Sales of Medical Devices” on April 28, 2025, which takes effect on October 1, 2025. This
NMPA issued the draft standard “Medical Devices – Part 1: Application of Usability Engineering to Medical Devices” on August 28, 2025 for feedback. Feedbacks need
Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros in October 2025. These updates are presented by China Med
Hainan Boao Pilot Zone allows overseas unapproved medical devices, IVDs, drugs, with clinical urgency status to be used in China. It does NOT require local
The NMPA recently released the industry standard YY/T 1987—2025, titled “Brain-Computer Interface Medical Equipment—Terminology”. This represents China’s first official standard dedicated to brain-computer interface (BCI)
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 released the “Clinical Evaluation Guideline for In Vitro Diagnostic Reagents for Cancer Screening” on August 21, 2025. The document provides direction for applicants preparing
Hainan Boao Pilot Zone allows overseas unapproved medical devices, IVDs, drugs, with clinical urgency status to be used in China. It does NOT require local