New China FDA Device Regs Have Companies Scrambling To Comply

New China FDA Device Regs Have Companies Scrambling To Comply-thegraysheet: More than 10 regulations pending from China FDA will target most aspects of devices’ product life cycle, ranging from clinical study requirements, regulatory approval, manufacturing and quality assurance through to postmarket surveillance. The long-awaited rules will also provide details on the implementation of the Medical Device Administration Regulation, the first comprehensive regulation targeting medical devices in China in more than a decade.