The purpose of clinical trials of medical devices is to evaluate whether the subject product has the expected safety and efficacy. Article IV of the clinical trials of medical devices should comply with the "World Medical Congress Declaration of Helsinki" (Annex 1) of the ethical principles, impartiality, respect for human dignity, and strive to maximize the benefit of the subjects and avoid harm as far as possible. Article V. Clinical trials of medical devices are divided into clinical trials of medical devices and clinical verification of medical devices.
The clinical trial of medical devices refers to the clinical use to verify the theoretical principles of the medical device, the basic structure, performance and other elements can ensure the safety and effectiveness.
Clinical verification of medical devices refers to the clinical use to verify that the medical device and the main structure, performance and other elements of the listed products are substantially equivalent, whether the same safety, effectiveness.
The scope of the clinical trial of medical devices: the market has not yet appeared, the safety and effectiveness of medical devices to be confirmed.
The scope of clinical verification of medical devices: similar products have been marketed, the safety and effectiveness of medical devices need to be further confirmed. Article VI prerequisites for clinical trials of medical devices:
(a) the product has a review of the registered product standards or the corresponding national and industry standards;
(b) the product has a self-test report;
(c) the product has the State Council's food and drug supervision and management department in conjunction with the State Council's quality and technical supervision departments recognized testing organizations issued by the type of products Test report, and the conclusion is qualified;
(D) the subject product for the first time for the implantation of medical devices, should have the product's animal test report;
Other need to confirm the safety of the product by the animal testing of human clinical trials of the product, should also be submitted to the animal test report. Chapter II Protection of the rights and interests of subjects Article VII of the clinical trials of medical devices shall not be charged to the subjects. Article 8 The person in charge of the clinical trial of medical devices or his/her delegate shall explain the following matters in detail to the subjects or their legal representatives:
(a) the subjects voluntarily participate in the clinical trial, and have the right to withdraw from the clinical trial at any stage;
(b) the confidentiality of the subjects' personal information. The ethics committee, the (food) drug regulatory authority and the implementer may access the subject's information, but may not disclose its contents to the public;
(iii) the medical device clinical trial program, in particular, the purpose, process and duration of the medical device clinical trial, the possible benefits expected of the subject and the risks that may arise;
(iv) during the period of the medical device clinical trial, the healthcare institution has the (D) during the clinical trial of medical devices, the medical institution has the obligation to provide the subjects with information related to the clinical trial;
(E) due to the trial product causes damage to the subjects, the implementer shall give the subjects the corresponding compensation; the relevant compensation shall be set out in the contract for the clinical trial of medical devices. Article IX subjects in the full understanding of the content of the clinical trial of medical devices on the basis of the "informed consent". In addition to the Informed Consent shall include the items listed in Article VIII of the Regulations, shall also include the following:
(a) the signature of the person in charge of the clinical trial of medical devices and the date of the signature;
(b) the signature of the subject or his legal representative and the date of the signature;
(c) the medical institution in the clinical trial of medical devices found in clinical trials of the subject product other than the expected impact, the relevant content of the "Informed Consent" must be revised and re-signed by the subject or his legal representative to confirm. Chapter III Clinical Trial Program for Medical Devices Article 10 The clinical trial program for medical devices is a document stating the purpose of the trial, risk analysis, overall design, trial methods and steps. Medical device clinical trials should be developed before the start of the trial program, medical device clinical trials must be conducted in accordance with the trial program. Article 11 The clinical trial program for medical devices shall be designed to maximize the protection of the rights and interests, safety and health of the subjects as the primary principle, and shall be formulated by the medical institution responsible for the clinical trial and the implementer in accordance with the prescribed format (Attachment 2)*** with the same design, and reported to the Ethics Committee for approval and implementation; if there is any modification, it must be agreed by the Ethics Committee. 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 marketed similar medical devices adverse events, or the efficacy of the medical device is not clear, the State Food and Drug Administration can develop a unified clinical trial program requirements.
Clinical trials of such medical devices, implementers, medical institutions and clinical trial staff should implement the provisions of the unified clinical trial program. Article XIV of the medical device clinical trial program should be specific to the characteristics of the product under test, to determine the number of clinical trials, duration and clinical evaluation criteria, so that the test results 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 and the effectiveness of the safety of the subject product.
Medical device clinical validation program should prove that the main structure of the test product and the marketed products, performance and other elements are substantially equivalent, whether the same safety, effectiveness.