Policies
China Cuts Import Tariffs on 28 Medical Devices and IVD Products in 2026; Artificial Joints and Certain Diagnostic Kits Now at Zero Tariff
China has applied provisional import tariff rates lower than the most-favored-nation rates on 935 items starting from January 1, 2026.
“China will, for example, reduce tariffs on certain key components and advanced materials to support high-level technological development, on certain resources to facilitate green development, and on some medical products, including artificial blood vessels, to improve people’s well-being”, the announcement states. Click HERE for more information.
GBA Urgent Use Guidance and Drugs & Devices Catalog Published
The Guangdong Provincial Medical Products Administration and the Guangdong Provincial Health Commission issued the “Administrative Measures for the GBA Urgently Needed Hong Kong–Macao Drugs and Medical Devices Catalog” on September 15, 2025, and the “Catalog of Urgently Needed Drugs and Medical Devices Imported from Hong Kong and Macao in the Nine Mainland Cities of the Greater Bay Area” on February 2, 2026.
Click HERE for the Q&A based on above two documents.
Guidelines & Standards
Navigating NMPA Approval for Mobile Medical Devices: A Review of Renewed Guideline
NMPA published the “Guideline for Registration of Mobile Medical Devices”, replacing the 2017 version. It forms an integral part of China’s Digital Health regulatory framework and serves as a supplement to other software & AI related documents, such as those on medical device software, cybersecurity, AI-assisted software, and human factors engineering.
Click HERE for our comprehensive analysis.
About China Med Device, LLC
China Med Device, LLC (www.ChinaMedDevice.com) provides turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA legal agent with offices in Boston, Beijing and Hainan, we can represent you for product life cycle without your need to create a local entity in China. Our RA services include strategy, registration, type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and PMS. Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.