Article X of the medical device clinical trial program is to clarify the purpose of the test, risk analysis, overall design, test methods and steps and other content of the document. Medical device clinical trials should be developed before the start of the test program, medical device clinical trials must be conducted in accordance with the test program.
Article XI of the medical device clinical trial program should be to maximize the protection of the rights and interests of the subjects, safety and health as the overriding principle, should be responsible for the clinical trial of the medical institutions and implementers in accordance with the prescribed format (Annex 2) **** with the design development, reported to the Ethics Committee for approval and implementation; if there is any modification, the Ethics Committee must agree.
Article XII of the market has not yet appeared in the third type of implantation or borrowed from the theory of Chinese medicine made of medical devices, clinical trial program should be filed with the medical device technical review body.
Article XIII has been on the market of similar medical devices adverse events, or the efficacy of medical devices is not clear, the State Food and Drug Administration may develop a unified clinical trial program provisions.
To carry out clinical trials of such medical devices, implementers, medical institutions and clinical trial personnel shall implement the provisions of the unified clinical trial program.
Article XIV of the clinical trial program for medical devices should be specific to the characteristics of the product under test, to determine the number of cases of clinical trials, duration and clinical evaluation criteria, so that the results of the test are statistically significant.
Medical device clinical trial program should prove the theoretical principles of the subject product, the basic structure, performance and other elements of the basic situation as well as the safety and effectiveness of the subject product.
Medical device clinical validation program should prove that the main structure, performance and other elements of the test product and the marketed products are substantially equivalent, whether the same safety, effectiveness.
Article XV of the medical device clinical trial program shall include the following:
(1) the title of the clinical trial;
(2) the purpose, background and content of the clinical trial;
(3) the clinical evaluation criteria;
(4) the risk and benefit analysis of the clinical trial;
(5) the name of the clinical trial personnel , position, title and department of service;
(vi) overall design, including analysis of the possibility of success or failure;
(vii) duration of the clinical trial and the rationale for its determination;
(viii) number of cases of the clinical trial for each disease and the rationale for its determination;
(ix) scope of the selection of the subjects, the number of the subjects and the rationale for their selection, and the setup of the control group, if necessary;
(j) Therapeutic products should have a clear indication or scope of application;
(k) the evaluation method of clinical performance and statistical treatment;
(l) the prediction of side effects and the measures that should be taken;
(m) Subjects of Informed Consent;
(xiv) the responsibilities of all parties.
Article 16 The medical institution and the implementer sign the clinical trial program agreed by both parties, and sign a clinical trial contract.
Article XVII of the clinical trials of medical devices should be conducted in more than two (including two) medical institutions.