摘要
国家对医疗器械实行分类管理,第一类医疗器械无需临床试验,第二类、第三类医疗器械生产注册之前应当通过临床试验(临床试用或临床验证)。医疗器械临床试验的伦理审查要点主要包括试验的科学设计;试验的风险和受益评估,区分重大风险临床试验和非重大风险临床试验;知情同意;受试人群的选择;受试者的医疗和保护等。医疗器械临床试验的批准标准和医疗器械紧急使用都应该符合相应的标准。
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 for beth Class II and Class III medical devices before they are put into production. Main points to consider when 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 for approval must be meet when approve a clinical trial of medical device, emergency use of medical devices should also meet corresponding standard.
出处
《中国临床药理学与治疗学》
CAS
CSCD
2005年第12期1437-1440,共4页
Chinese Journal of Clinical Pharmacology and Therapeutics
基金
国家科学技术部"临床试验关键技术及平台研究"课题资助(№2004AA2Z3766)
关键词
临床试验
伦理委员会
伦理审查
医疗器械
clinical research
institutional review board
ethic review
medical devices
