The National Medical Products Administration issued a new version of the"Good Clinical Practice for Medical Devices(GCP)"in March 2022,which deleted specific requirements for the constitution and operation of the ethics committee and simplified the processes of submitting initial review documents and reporting serious adverse events in clinical trials.Firstly,the new requirements for ethics committees were sorted out and analyzed,including responsibilities,compositions,qualifications and training of members and secretaries,as well as the management of archives.Secondly,it elaborated on the new requirements for ethical initial reviews,including submission of materials,contents,methods,and conclusions of the review,as well as the learning curve risk management of drug-device combination medical devices and medical devices during use.It emphasized the compliance and validity of informed consent,strictly limited the conditions for exemption from informed consent,and redefined the organizations and individuals allowed to access trial data.Finally,it elaborated on the new requirements for follow-up review of serious adverse events,device defects,and new requirements for the correction clinical trial data after project the completion.The new version of the GCP is more operational and puts forward higher requirements for the review quality and efficiency of the ethics committee.The ethics committee should improve the review efficiency on the premise of ensuring the quality of the review,to effectively protect the safety,rights and interests of the subjects.

By sorting out the research of new generation of artificial intelligence (AI) independent software reviewed by medical ethic committee of a grade A tertiary hospital in Beijing from January 2017 to November 2021, this paper analyzed and summarized the common problems involved in multiple dimensions, such as the integrity of the protocol design, protection of the rights and interests of the subjects, the data using and storing, and proposed that ethic committee should pay special attention to the protocol integrity, data security, risk assessment, track review, and other aspects different from conventional clinical research, thus providing a idea for ethical review of new generation AI independent software research.

Due to the rapid development of new medical devices and the national policy adjustment of medical device review and approval, the difficulty of clinical trial institution and ethics committee in the risk assessment of medical device clinical trials has greatly increased. By sorting out the legal norms, standards and safety evaluation materials of medical devices, this paper systematically summarized and suggested the existing risks in clinical trials of medical devices from seven aspects, including the collection and utilization of biological sample, site environment safety, information security, product production and inspection, use of device, clinical trial design, and technical capabilities, with a view to providing a reference basis for the sponsors, clinical trial institutions, and ethics committees to scientifically establish a risk assessment system for medical devices before clinical trials, thereby reducing potential risks of compliance and safety during the clinical trial process.