China – Medical device regulators revise Clinical Trial Quality Management Regulation and various device-specific guidelines and technical review points

Several new guidelines have been announced by medical device market regulators in China.

First, the Chinese National Medical Product Administration (NMPA) released updates regarding rules for clinical trials of medical devices and IVD reagents conducted for the purpose of device registration.

Second, the Center for Medical Device Evaluation (CMDE) published device-specific guidelines including Registration Review Guidelines for Intravascular Guidewires. In addition, the CMDE published Guidelines for Stability Studies of Passive Implantable Medical Devices, 2022 Revision…