Abstract: As an important part of the Big Health Industry, in vitro diagnostic(IVD) reagents play a vital role in the prevention, diagnosis and treatment of diseases. In recent years, especially after the novel coronavirus infection, IVD industry has developed rapidly in China, but it still cannot meet the needs of clinical use. By conducting desk research, expert interview, manufacturer survey and hospital survey, this study analyzed the development status of IVD industry in Shanghai, summarized the problems encountered in the high-quality development from the aspects of raw materials, innovation ability, and clinical trials, etc., and proposed recommendations for promoting the high-quality innovation and development of IVD industry in Shanghai.