* The SFDA Medical Device Quality Supervision and Inspection Center conducts testing on products.
** CCC Mark = China Compulsory Certificate. Required for several categories of devices, most of which have an electrical component.
A CCC Mark application must be submitted prior to product registration and a facility inspection is required for CCC Mark approval.
*** Clinical trials may need to be conducted in China for Class II/III devices that do NOT already have regulatory approval elsewhere in the world, long term implantable devices or certain other high risk devices. If clinical trials have been conducted outside China and the device has US, European or other national approval, the data will likely be accepted by the SFDA.