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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 partner in Chinese market access.
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 28, 2025 which takes effect
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 feedback. In a move that
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 regulation establishes a comprehensive framework
NMPA issued the draft standard “Medical Devices – Part 1: Application of Usability Engineering to Medical Devices” on August 28, 2025 for feedback. Feedbacks need to be submitted by October
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 Device, LLC, your partner in
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 type testing or significant burden
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) medical devices, providing a structured
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 released the “Clinical Evaluation Guideline for In Vitro Diagnostic Reagents for Cancer Screening” on August 21, 2025. The document provides direction for applicants preparing registration dossiers and clinical evaluation
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 type testing or significant burden
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 partner in Chinese market access.