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2025 China NMPA Bluebook is here:
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.
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 regulation will take effect on
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. The inventors include Dong Xiaoguang,
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) and manufactured by Shandong Baiduoan
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 Within a Risk Management Process”
NMPA Center for Food and Drug Inspection issued the “Notice of Unannounced Inspections Results in 2nd batch of 2025” on August 15, 2025. The unannounced inspections, also called surprise inspections
The NMPA Center for Medical Device Standardization Administration issued the “Notice on Soliciting Opinions on Adjustments of the Medical Device Classification Catalog” on August 7, 2025. Feedbacks need to be