China Streamlines Reviews of Innovative Devices
China’s State Drug Administration is implementing a new device review procedure to bring innovative devices to market faster and to encourage more innovation in China’s supply chain.
The new Special Examination Procedure for Innovative Medical Devices, which becomes effective Dec. 1, aims to improve the efficiency of device reviews and inspections.
The new special examination procedure replaces the green channel special approval process launched in 2014. The document refines the application process, improves the initial review and prioritizes licensing requirements for innovative devices.