Medical Devices

NMPA’s 2025 IVD Catalogue is now in effect with key changes for overseas registration. Contact Cisema for expert support.

China’s 2025 enforcement cases spotlight compliance risks in medical device online sales and what global sellers must do to stay aligned.

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.