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2026 China NMPA Bluebook is here:
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 regulatory submissions. The standards will
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. Referenced to ISO 13485, EU
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
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
NMPA Center for Medical Device Standardization Administration released “Drug-Device Combination Products Classification Results (June 2024 to May 2025) on July 7. The document identifies 7 drug-led combination products and 46
Thirty-six medical devices standards will take effect in July 2025, including three national standards for cardiovascular implants. These newly established or revised standards are aimed to facilitate manufacturers with local