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2026 China NMPA Bluebook is here:
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
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
The Shanghai Municipal Medical Products Administration issued the “Provisions on Transferring Medical Devices with Existing Registration Certificates into Shanghai Production” on August 14, 2025. The
Patent Background One of the patents for medium-term corneal preservation solution (Application No. CN200410091007.5, filed on November 15, 2004) was submitted by Shandong Eye Institute.
On June 27, 2025 NMPA approved the corneal preservation solution, developed by the team at Shandong First Medical University Affiliated Ophthalmic Hospital (Shandong Eye Hospital)
The NMPA National Institutes for Food and Drug Control released the draft GB/T 16886.1-2025, “Biological Evaluation of Medical Devices — Part 1: Evaluation and Testing