关键词: 临床试验, 伦理委员会, 伦理审查, 医疗器械

Abstract: Medical devices are administered according to certain classification by the state,and Class I medical devices need not be evaluated by clinical trial,while clinical evaluation must be conducted forboth Class II and Class III medical devices before they are put into production.Main points to considerwhen reviewing clinical trial with medical devices are as follows: scientific design of clinical trial;benefits and risks of the trial,differentiating clinical trial of significant risk and that of nonsignificant risk;informed consent;selection of subjects group;medical care and protection of subjects,etc.The criteria forapproval must be meet when approve a clinical trial of medical device,emergency use of medical devices should also meet corresponding standard.

Key words: clinical research, institutional review board, ethic review, medical devices