China May Streamline Regulations for Device Registration, Trials

China’s State Food and Drug Administration (SFDA) soon will no longer require devicemakers to register products in the country of export as a condition of registration and will not automatically require clinical trials in China for certain classes of devices. The changes are part of an overhaul of the country’s device regulations in which the SFDA also says it will consider establishing an exemption from its requirement to test product samples in Chinese labs prior to approval if a devicemaker demonstrates compliance with international standards and provides sound scientific evidence.
International Medical Device Regulatory Monitor