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为进一步加强医疗器械临床试验监督管理,近日,国家食品药品监督管理总局、国家卫生和计划生育委员会联合发布《医疗器械临床试验质量管理规范》(食品药品监管总局令第25号)。《规范》共11章96条,包括总则、临床试验前准备、受试者权益保障、临床试验方案、伦理委员会职责、申办者职责、临床试验机构和研究者职责、记录与报告、试验用医疗器械管理、基本文件管理、附则。《规范》将于2016年6月1日起施行。
In order to further strengthen the supervision and administration of clinical trial of medical devices, recently, the State Food and Drug Administration and the State Health and Family Planning Commission jointly released the “Code of Practice for Clinical Trial of Medical Devices” (Decree No.25 of the State Food and Drug Administration). The Code contains a total of 11 chapters and 96 articles, including general rules, preparation for clinical trials, protection of subjects’ rights and interests, clinical trial programs, ethics committee responsibilities, sponsor responsibilities, responsibilities of clinical trial institutes and researchers, records and reports, experimental medical Device Management, Basic Document Management, Supplementary Provisions. The Code will come into effect on June 1, 2016.