This specification covers the whole process of medical device clinical trials, including clinical trial program design, implementation, supervision, verification, inspection, and data collection, recording, analysis and summary and reporting. Article 3 The medical device clinical trial referred to in this specification, refers to the qualification of the medical device clinical trial organization, to apply for registration of medical devices in the normal use of the safety and effectiveness of the process of confirmation or verification. Article 4 The clinical trial of medical devices shall follow the principles of law, ethical principles and scientific principles. Article V above the provincial level food and drug supervision and management department is responsible for the supervision and management of clinical trials of medical devices.
The competent authorities in charge of health planning to strengthen the management of clinical trials of medical devices within the scope of responsibilities.
Food and drug supervision and management departments, the competent departments of health and family planning shall establish a mechanism for quality management of clinical trials of medical devices to strengthen the third class of medical devices, medical devices included in the national large medical equipment configuration management items to carry out clinical trials for approval and the corresponding supervision and management of clinical trials and the notification of information data. Chapter II Preparation for Clinical Trials Article 6 The clinical trial of medical devices should be conducted on the basis of adequate scientific evidence and a clear test purpose, and weigh the expected benefit to the subjects and public health and risk, the expected benefit should exceed the possible damage. Article VII before the clinical trial, the sponsor shall complete the test of medical devices for preclinical research, including product design (structural composition, working principle and mechanism of action, intended use and scope of application, applicable technical requirements) and quality inspection, animal testing and risk analysis, and the results should be able to support the clinical trial. Quality inspection results include self-inspection reports and qualified inspection agency issued within one year of the product registration inspection report. Article VIII before the clinical trial, the sponsor should prepare adequate test medical devices. The development of test medical devices should be consistent with the applicable medical device quality management system requirements. Article IX clinical trials of medical devices should be in two or more than two medical device clinical trial organizations.
Selected test institutions should be recognized by the qualification of medical device clinical trial institutions, and facilities and conditions should meet the needs of safe and effective clinical trials. The investigator should have the professional expertise, qualifications and ability to undertake the clinical trial, and after training.
Medical device clinical trial organization qualification management by the State Food and Drug Administration in conjunction with the National Health and Family Planning Commission to develop. Article 10 Before the clinical trial, the sponsor and the clinical trial organization and the investigator shall reach a written agreement on the trial design, trial quality control, the division of responsibilities in the trial, the sponsor to bear the costs associated with the clinical trial, as well as the principles of treatment of injuries that may occur in the trial. Article 11 The clinical trial shall obtain the consent of the ethics committee of the medical device clinical trial organization. Included in the third class of medical devices subject to clinical trial approval catalog, should also be approved by the State Food and Drug Administration. Article XII of the clinical trial, the applicant shall be the location of the province, autonomous region, municipality directly under the Central Food and Drug Administration for the record.
The food and drug supervision and management department to accept the record should be notified of the filing of the clinical trial organization at the same level of food and drug supervision and management department and the competent department of health and family planning. Chapter III Protection of the rights and interests of subjects Article XIII of the clinical trials of medical devices should follow the ethical guidelines established by the World Medical Congress Declaration of Helsinki. Article 14 Ethical review and informed consent are the main measures to protect the rights and interests of subjects.
Parties involved in clinical trials shall bear the corresponding ethical responsibilities in accordance with their respective duties in the trial. Article 15 The sponsor shall avoid improperly influencing or misleading the subjects, clinical trial organizations and investigators and other clinical trial participants or related parties.
Clinical trial organizations and researchers shall avoid improperly influencing or misleading subjects, sponsors and other clinical trial participants or related parties. Article 16 The sponsor, the clinical trial organization and the investigator shall not exaggerate the compensation measures for participation in the clinical trial and mislead the subjects to participate in the clinical trial. Article 17 Prior to the clinical trial, the sponsor shall submit the following documents to the Ethics Committee through the investigator and the medical device clinical trial management department of the clinical trial institution:
(i) the clinical trial protocol;
(ii) the investigator's manual;
(iii) the text of the informed consent form and any other written materials provided to subjects;
(iv) Procedural documents for recruiting and informing subjects;
(v) Text of the case report form;
(vi) Self-inspection report and product registration test report;
(vii) Investigator's curriculum vitae, professional expertise, competence, acceptance of training, and other documents that can prove his/her qualifications;
(viii) Facilities and conditions of the clinical trial organization that can meet the trial's Overview;
(ix) statement that the development of the medical device for the trial complies with the relevant requirements of the applicable medical device quality management system;
(x) other documents related to ethical review.
The Ethics Committee shall review and supervise the implementation of the clinical trial in adherence to the principles of ethics and science.