【正文】 (five) familiar the relevant national laws, regulations and the code.Sixtysecond clinical trials, clinical trials of medical device clinical trials management department should cooperate with the applicant to apply to the ethics mittee, and in accordance with the provisions of the relevant documents submitted.Article 63 researchers should ensure that participating in the trial of the r。 (three) familiar with the applicant and the requirements related to clinical trial data, documents。s agreement to properly preserve the clinical trial records and basic documents.Study on the sixtyfirst responsible for clinical trials should meet the following conditions: (a) associate professor is deputy director of the physician, in the clinical trial institution, associate deputy high above the relevant professional titles and qualifications。 (five) test of medical devices should be qualified, it is easy to identify, the correct encoding and labeled test of the special logo, and according to the clinical test Program requirements for appropriate packaging and preservation。 (three) retain the basic documents and test the less than less than the statutory time, clinical trials and research institutions are no longer need to notice until the sponsor of the documents so far。 and (IV) test with medical device manufacturing with suitable medical equipment quality management system requirements of the statement.Article fortysecond the applicant in the organization of the development of clinical trials program may not exaggerate the mechanism and efficacy of medical devices.Article 43 in clinical trials, the sponsor to get important information about clinical trials shall modify the Handbook of research and related documents in time, and through the clinical trial institution of medical instrument clinical trial management departments submit ethics review mittee agreed.Fortyfourth the applicant should with clinical trial institutions and researchers to reach a written agreement on the following issues: (a) clinical trial implementation in accordance with the relevant laws and regulations and the clinical trial program, and accept the inspection, verification and inspection。 (II) test summary of medical devices for。 rights and interests can not get security situation, can be in any time upon written request to suspend or terminate the trial. Clinical trials have been suspended, without the consent of the ethics mittee should not be allowed to resume.Thirtyseventh ethics mittees shall retain all records relating to the pletion of clinical trials for at least 10 years.The sixth chapter is the responsibility of the applicantArticle 38 The sponsor is responsible for initiating, application, organization and monitoring of clinical trials and the authenticity of clinical trials, responsible for reliability. The sponsor is usually the medical device production enterprise. The sponsor for overseas institutions shall in accordance with the provisions within the territory of the people39。 (III) without consent。 when necessary, the ethics mittee shall organize the participants on behalf of the level of understanding of the test data, the evaluation of informed consent is appropriate, the assessment results shall be the end of the 10 year written record and save to clinical trials (six.) subjects if the occurrence of clinical trial related injury or death, treatment and insurance measures for adequacy. (seven) whether the proposed amendments to the test scheme is acceptable. (eight) whether can be carried out in clinical trials in regular evaluation may harm to subjects from (nine). The test plan may affect the rights and interests of the subjects, safety and health, or affect the scientific nature, the integrity of the test, whether it can be accepted.Ethical review thirtyfourth multicenter clinical trial should be led by the ethics mittee responsible for the establishment of collaborative review procedures to ensure consistency and timeliness of the review work. The beginning of each clinical trial institution before the test should be led by the ethics mittee responsible for examination and test scheme of ethical rationality and scientificity, participate in the test of other clinical trial institution ethics the Committee in the prerequisite of accepting the lead unit ethics mittee review ments, can be used to review or file review, review the feasibility of the trials in this clinical trial institutions, including the qualification and experience of the equipment and conditions, generally no longer on the design scheme of the test proposed amendments, but not right approved test in clinical trials.Article 35 The Ethics Committee receives the application of clinical trials of medical devices shall convene a meeting, discuss the review, issue a written opinion, seal, and attached to attend the meeting of the personnel list, professional and personal signature. The views of the ethics mittee may be: (a) consent。 (7) after the end of the multi center clinical trials, each clinical trial institutions researchers should respectively issued a summary of clinical trials, together with a case report table in accordance with the provisions of the audited over by coordinating research summary report.Fifth chapter ethics mittee dutiesArticle 30 medical device clinical trial institution ethics mittee shall be by at least five members, including medical professionals, medical professionals, which should be the members of the different gender. Non medical specialty mittee at least a legal worker and a name for the clinical trial institution other than the personnel. The ethics mittee should be with the assessment and evaluation of the clinical trials of science, medicine and ethics, and other aspects of qualification or experience. All members should be familiar with ethical guidelines for the clinical trial of medical apparatus and instruments and relevant regulations and abide by the ethics mittee o