医疗器械临床试验质量管理规范英文版

State Food and Drug AdministrationNational Health and Family Planning CommissionNumber twenty — fift

State Food and Drug Administration National Health and Family Planning Commission fifth — Number twenty has 〉 <medical equipment specification for the quality control of clinical trial of been state food and Drug Administration in the executive meeting of the, national health and Family Planning Commission, director of the committee meeting 2016 ， examined and adoptedis hereby promulgated, since June 1 ， implementation. Director Bi Jingquan Director Li Bin March 1, 2016 Standard for quality management of medical device clinical trials Chapter one is the first chapter The first is to strengthen the management of medical device clinical trials, the maintenance process for clinical trials of medical devices in rights and interests, and to guarantee the medical device clinical trials process specification, real results, the supervision and administration 〈 science, reliable and traceableaccording to ， of Medical Devices Regulations >formulated this specification. blic of China stoRepucarry out the ’ Article 2within the territory of the people clinical trial of medical apparatus and instruments, shall comply with the specification This specification covers the whole process of medical device clinical 。 the implementation of, monitoring, ， trials including design of clinical trials ，