USCBC Joint Letter to CFDA-NHFPC on Good Clinical Trial Practice for Medical Devices (GCPs)

The "Medical Device Clinical Trial Quality Management Norms" (or "Good Clinical Trial Practice for Medical Devices" (known as new China GCP) jointly issued by your sides became implemented from June 1 this year. We commend that the new China GCP has played an active role in strengthening the clinical trial for medical devices. However, we found that in a number of trainings organized by relevant departments, due to the difference in interpreting and understanding some items in the new China GCP between the regulating agencies and the related firms, it has led to some confusions and problems hard to be resolved by our members during the actual practice. Therefore we would appreciate your attention to and solution to these problems.