Abstract: As an important part of clinical diagnosis and treatment, the safety and effectiveness of medical devices are directly related to the life, health, and safety of patients. With the continuous development of science and technology, more and more investigator-initiated trial using unlisted medical devices, which brings great risks and challenges. According to the existing laws and regulations in China, medical devices that are not approved for marketing in principle cannot be used in investigator-initiated trial. Through the policy guidance and technical support of the regulatory authorities, risk assessment carefully and hierarchical management, continuous capacity-building among healthcare institutions, ethics committees, and investigators, establish and improve the protection system for the rights and interests of research participants, investigator-initiated trial using unlisted medical devices will be promoted to a more scientific and standardized direction.