《医疗器械临床试验质量管理规范》英文版.docVIP

State Food and Drug AdministrationNational Health and Family Planning CommissionNumber twenty-fifth medical equipment specification for the quality control of clinical trial of has been state food and Drug Administration in the executive meeting of the, national health and Family Planning Commission, director of the committee meeting examined and adopted, is hereby promulgated, since June 1, 2016 implementation.Director Bi JingquanDirector Li BinMarch 1, 2016Standard for quality management of medical device clinical trialsChapter one is the first chapterThe 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, science, reliable and traceable, according to the supervision and administration of Medical Devices Regulations formulated this specification.Article 2 within the territory of the peoples Republic of China to carry out the clinical trial of medical apparatus and instruments, shall comply with the specification. This specification covers the whole process of medical device clinical trials, including design of clinical trials, the implementation of, monitoring, verification, inspection, and data acquisition, record, and analyze the summarizing and reporting.The third section of this specification referred to in the clinical trial of medical apparatus and instruments, refers to in the accreditation of medical instrument clinical trial institution, intends to apply for the registration of medical device in the normal conditions of use is safe and effective for confirmation or verification process.Fourth clinical trials of medical devices shall comply with the principles of law, ethical principles and scientific principles.Article 5 at or above the provincial level food and drug supervision and management departments responsible for the supervision and mana