FDAnews
www.fdanews.com/articles/111746-china-streamlines-regulatory-reviews-of-certain-imported-medical-devices

China Streamlines Regulatory Reviews of Certain Imported Medical Devices

October 29, 2008
Foreign companies that export medical devices to China may find the process of gaining market entry less burdensome than it has been in the past, thanks to a recent decision to streamline regulatory requirements for eight types of imported devices. The change, announced last month at the 19th U.S.-China Joint Commission on Commerce and Trade, merges some premarket review processes, resulting in one test, one report, one fee and one factory inspection for the devices.