In order to further regulate the whole process of clinical trials of medical devices and enforce administration over clinical trials of medical devices, based on Good clinical practice for medical devices, CFDA issued 6 documents including the template of application and review form for ethical review of clinical trials of medical devices, template of informed consent, template of case report of clinical trials of medical devices, template of clinical trials plan of medical devices, template of clinical trials report of medical devices and list of essential documents that shall be filed for clinical trials of medical devices. Those documents are now announced and to be implemented simultaneously with Good clinical practice for medical devices.