Medical Devices

Learn about CMDE’s new guidelines on titanium implant device registration in China and how they impact international manufacturers.

New CMDE guidelines standardize registration for orthopedic and dental devices in China. Key info for global manufacturers.

Hong Kong CMPR will be established by 2026, with a phased primary evaluation system for new drug registration implemented through 2030.

NMPA released a draft revision on April 7, 2025, impacting classification rules for medical devices in China. Submit feedback by May 7.

Learn about China's April 2025 CMDE guidance on metal bone needle products and how it affects international orthopedic device manufacturers.

Beijing and Shenzhen implement new policies to fast-track access for innovative drugs and devices in China.

China's 2025 legislative plan includes the draft Medical Device Management Law, introducing life-cycle regulation and compliance.

China’s CMDE issued Notice No. 3 (2025) to fast-track innovative medical devices and raise standards for non-innovative products.

Learn how China’s medical device master file system supports confidential documentation, protects IP, and streamlines regulatory reviews for international manufacturers.

Key outcomes from China’s 2025 Two Sessions highlight regulatory updates, innovation policies, and new market opportunities for international medical device manufacturers.

The NMPA has released the 2025 National Medical Device Sampling Inspection Plan. Learn about new inspection processes, reinspection rights, and compliance strategies for entering the Chinese market.

The NMPA's updated Guidelines for On-site Inspection of Medical Device Distribution took effect on July 1, 2024, replacing the 2015 version. Learn how these changes affect overseas manufacturers entering the Chinese market.