关键词: 医疗器械, 临床试验数据, 真实性和完整性, 监督检查

Abstract:

In order to strengthen the supervision about clinical trials of medical devices, National Medical Products Administration (NMPA) inspects the clinical trials of medical devices to projects in the process of evaluation annually, and ensures the truth and validity about the data of clinical trials of medical devices. This paper summarizes the situation of supervision about clinical trials of medical devices in the past three years and the main problems existed in clinical trials of medical devices in China. The purpose is to strengthen the attention of applicants and clinical trial units to the quality of clinical trials, and to improve the level about clinical trials of medical devices in China.

Key words: medical device, clinical trial data, authenticity and integrity, inspection