Abstract:Objective This article aims to embrace the new formats and challenges in China’s medical device inspection and testing industry, and explore the future development direction of the industry. Methods Based on summarzing the current status of the inspection and testing industry of medical devices, through expert interviews and an online questionnaires, we surveyed 40 medical device inspection and testing institutions and related enterprises and institutions, focusing on important issues such as technological innovation capabilities and forms, and industry development bottlenecks. Results Through analysis and organization of the survey data, we have predicted five major industry development trends: improving overall organizational layout and planning and establishing regionally distinctive centers; enhancing access and regulatory mechanisms for third-party cooperative research organizations and third-party review institutions; promoting technological innovation and optimizing talent teams, enabling high quality development for inspection and testing technology; building a shared platform for medical device safety regulation information; and strengthening detection and safety monitoring of in-use medical equipment. Innovation The innovation of this article lies in the utilization of expert interviews and evidence-based research methods, obtaining objective and reliable data, and providing substantial evidence for the study and exploration of industry development trends.