
Seven NMPA Draft Guidelines Released in a Single Day
NMPA published seven medical devices draft guidelines on November 11, 2025. They are aimed to facilitate manufacturers with clarity in registration process. Significance of Device
Register for Upcoming Webinar on DEC. 8 @ 11AM
2026 China NMPA Bluebook is here:

NMPA published seven medical devices draft guidelines on November 11, 2025. They are aimed to facilitate manufacturers with clarity in registration process. Significance of Device

Fifteen newly established or revised industry standards were released by NMPA on October 30, 2025, to guide manufacturers for type testing, pre-clinical, clinical studies, and

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