Administrative Regulations for Expanded Clinical Trials of Medical Devices
On March 20, 2020, NMPA released an Administrative Regulations for Expanded Clinical Trials of Medical Devices (Trial) in order to further encourage the innovation of medical devices and support expanded clinical trials of medical devices. The expanded clinical trials of medical devices aim to the patients with life-threatening diseases that do not have effective treatments, and the non-approved medical devices can be used in the clinical trial bases.
