Medical Device Clinical Trial Quality Management StandardsState Food and Drug Administration National Health and Family Planning Commission Number twenty-fifth < medical equipment specification for

of medical devices, through the use of human subjects or animals, to evaluate the safety and effectiveness of the devices, or to obtain clinical data for the purpose of registration. Chapter two clinical trial design and implementation of the first section of clinical trial design Article 4 clinical trial design should be scientific, reasonable, and in line with the purpose of the trial, and should be based on the characteristics of the medical device and the characteristics of the disease or condition being studied. Article 5 clinical trial design should be based on the principles of ethical review and should be reviewed and approved by the ethics committee. Article 6 the design of clinical trials should be based on relevant national and international standards and guidelines, and should be consistent with the applicable laws and regulations. The second section of the implementation of clinical trials Article 7 clinical trials should be carried out in accordance with the approved clinical trial plan, and should be conducted in strict accordance with the applicable laws and regulations, ethical principles, and the requirements of this specification. Article 8 the implementation of clinical trials should be conducted by qualified personnel with appropriate qualifications and experience, and should be conducted in accordance with the applicable standard operating procedures. Article 9 clinical trial sites should have the necessary facilities, equipment, and personnel to conduct clinical trials, and should meet the requirements of relevant laws, regulations, and guidelines. Chapter III clinical trial monitoring and verification of the first section of clinical trial monitoring Article 10 clinical trial monitoring should be conducted in accordance with the approved clinical trial plan and the monitoring plan, and should be conducted by qualified personnel with appropriate qualifications and experience. Article 11 the monitoring of clinical trials should focus on the main aspects of the trial, including the safety and effectiveness of the medical device, the quality of the trial data, and the compliance of the trial with the applicable laws and regulations. Article 12 the monitoring of clinical trials should be conducted in a timely and effective manner, and the results of the monitoring should be recorded and reported in a timely manner. The second section of clinical trial verification Article 13 clinical trial verification should be conducted in accordance with the approved clinical trial plan and the verification plan, and should be conducted by qualified personnel with appropriate qualifications and experience. Article 14 clinical trial verification should focus on the authenticity, reliability, and integrity of the trial data, and should be conducted in accordance with the applicable laws and regulations. Article 15 the results of clinical trial verification should be recorded and reported in a timely manner, and any deviations or violations should be addressed and corrected in a timely manner. Chapter IV inspection and data acquisition of the first section inspection and data acquisition Article 16 the inspection and data acquisition of clinical trials should be conducted in accordance with the approved clinical trial plan and the inspection and data acquisition plan, and should be conducted by qualified personnel with appropriate qualifications and experience. Article 17 the inspection and data acquisition of clinical trials should focus on the safety and effectiveness of the medical device, the quality of the trial data, and the compliance of the trial with the applicable laws and regulations. Article 18 the results of inspection and data acquisition should be recorded and reported in a timely manner, and any deviations or violations should be addressed and corrected in a timely manner. Chapter V data recording, analysis and summary report of the first section data recording and analysis Article 19 the data recorded during clinical trials should be complete, accurate, and reliable, and should be recorded in a timely manner according to the requirements of the clinical trial plan. Article 20 the data analysis of clinical trials should be conducted in accordance with the approved statistical analysis plan, and should be conducted by qualified personnel with appropriate qualifications and experience. Article 21 the results of data analysis should be recorded and reported in a timely manner, and any deviations or violations should be addressed and corrected in a timely manner. The second section of the summary report of clinical trials Article 22 the summary report of clinical trials should be based on the clinical trial plan, and should be scientific, comprehensive, and objective. Article 23 the summary report of clinical trials should include the design of the trial, the implementation of the trial, the monitoring and verification of the trial, the inspection and data acquisition of the trial, and the data recording, analysis and summary report of the trial. Article 24 the summary report of clinical trials should be submitted to the relevant regulatory authorities for review and approval, and should be made public in accordance with the applicable laws and regulations. Chapter VI supplementary provisions Article 25 this specification shall be implemented as of June 1, 2016