Medical device clinical trial organizations should establish quality management system includes the following:
Code for Quality Management of Medical Device Clinical Trials
Chapter 1 General Principles
Article 1 In order to strengthen the management of the clinical trials of medical devices, to safeguard the rights and interests of the subjects in the process of clinical trials of medical devices, to ensure that the process of clinical trials of medical devices is standardized. In order to strengthen the management of medical device clinical trials to safeguard the rights and interests of the subjects in the process of medical device clinical trials, to ensure that the process of medical device clinical trials standardized, the results are true, scientific, reliable and traceable, according to the "Regulations for the Supervision and Administration of Medical Devices", the development of this standard.
The second in the Chinese people *** and the territory of the State to carry out clinical trials of medical devices, should follow this specification.
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 process of confirming or verifying the safety and efficacy of the medical device to be applied for registration in the normal conditions of use in the medical device clinical trial institutions accredited by the qualification.
Article 4 The clinical trial of medical devices shall be conducted in accordance with 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 department 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 the quality management of clinical trials of medical devices to strengthen the third class of medical devices, medical devices included in the national large-scale medical equipment configuration management items to carry out clinical trials for the approval of the situation, as well as the corresponding supervision and management of the clinical trials of the data information notification.
Chapter II Preparation for Clinical Trials
Article VI of the clinical trials of medical devices should have a sufficient scientific basis and a clear purpose of the trial, and weigh the expected benefit to the subjects and public health and risk, the expected benefit should exceed the possible damage.
Article VII of the clinical trial, the sponsor shall complete the test with a medical device preclinical research, including product design (structural composition, principle of operation and mechanism, 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 of the clinical trial, the sponsor should prepare adequate test medical devices. The development of medical devices for testing should be consistent with the applicable quality management system requirements for medical devices. Article IX of the medical device clinical trials should be conducted in two or more 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.