【正文】 sChapter 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 people39。s Republic of China to carry out the clinical trial of medical apparatus and instruments, shall ply 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 ply 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 management of medical device clinical trials. Health and family health department in charge, within its scope of functions and duties, strengthen the clinical trial of medical apparatus and instruments management. Food and drug supervision and management departments, health and family health departments should establish the medical quality of clinical trial management information reporting mechanism, strengthen the class III medical devices, included in the national configuration of large medical equipment quality management objective of medical apparatus and instruments to carry out examination and approval of clinical trials and the corresponding clinical trial supervision and management of data munications.The second chapter is the preparation before clinical trialArticle 6 the clinical trial of medical apparatus and instruments shall have sufficient scientific basis and the clear purpose of the test, and weigh on expected and the public health benefit and risk, expected benefit should exceed the possible damage.Article 7 before clinical trials, the sponsor shall test done in preclinical studies of medical apparatus and instruments, including product design (structure, working principle and mechanism of action, is expected to use and scope of application, the applicable technical requirements and quality inspection, animal testing and risk analysis and results should be able to support the clinical trial. Quality inspection results including self inspection report and a qualified inspection agency issued a year within the product registration inspection report.Prior to the eighth clinical trials, the applicant should prepare adequate testing of medical equipment. The development of the test with medical equipment shall meet the applicable requirements of the medical device quality management system.The nine clinical trials of medical devices shall be in two or more than two medical device clinical trial institution. Selected testing institutions shall be without qualification accreditation of medical instrument clinical trial institution, and facilities and conditions shall meet the safety effectively clinical trial experience. Researchers should be able to bear the clinical trials of specialty, qualification and ability and trained. Qualification of medical instrument clinical trial institution identified management measures shall be formulated separately by the State Food and drug administration shall, jointly with the Ministry of health and Family Planning Commission.Article 10 before clinical trials, the sponsor and clinical trial institutions and researchers should test design, test quality control, test the division of responsibilities, sponsor to bear the costs associated with the clinical trial and test in may occur damage dealing with principles to reach a written agreement.Article 11 clinical trials should obtain consent of the clinical trial of medical apparatus and instruments institutional ethics mittee. Included in the need for clinical trials and approval of class III medical devices directory, should also be approved by the State Food and drug administration.Article 12 prior to clinical trials, the sponsor shall be to the location of provinces, autonomous regions, municipal food and drug supervision and management departments for the record. Accept filing of food and drug supervision and administration department shall record the situation informed clinical trial institution is located at the same level of food and drug supervision and management departments, as well as health and family health departments.The third chapter is the protection of the rights and interests of the subjectsThirteenth clinical trials of medical devices shall ply with the ethical standards set by the Helsinki declaration of the world medical assembly.The fourteenth ethical review and informed consent are the main measures to protect the rights and interests of the subjects. The parties involved in clinical trials should assume the corresponding ethical responsibilities according to their respective responsibilities.Article 15 the sponsor should avoid undue influence or misleading to subjects, clinical trials and research and clinical trial participants or related party. Clinical trial institutions and researchers should avoid undue influence or misleading to subjects, the sponsor and other participants in clinical trials or interested parties.Sixteenth applicants, clinical trials and researchers should not exaggerate the pensation me