Medical Devices

NMPA issues Medical Device Clinical Evaluation Exemption 2025 impacting international medical device registration strategies

CMDE issues rules for faster medical device reviews, supporting innovation and speeding up market access in China.

NMPA Q&A clarifies medical device site inspection compliance, guiding overseas manufacturers on release, quality, and system standards.

Malaysia and China launch a regulatory reliance pilot to streamline IVD medical device registration and accelerate cross-border market access.

China’s 2025 IVD clinical trial exemption catalogue expands to 445 products, affecting clinical evidence requirements and IVD registration in China.

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.