New China Fast-track Review Allows International Devices Accelerated Approval-thegraysheet: China FDA released the finalized Special Review and Approval Procedure for Innovative Medical Devices Feb. 7, which allows both domestic and international device manufacturers to apply for accelerated approval, at least in theory. According to the regulation, China FDA promises early involvement, dedicated personnel and active communication with applicants, and a science-based review to speed up review time for qualified devices.
