Objective: Focus on “precise medical” and explore the development needs of in vitro diagnostic reagents industry in “precise medical” work, in order to promoting the development of high-end diagnostic medical products involved in “precise medical” in China. Method: From the aspects of industrial strategy, industrial policy, innovative technology and quality safety, the key elements of innovative system for diagnostic products are analyzed, to provide reference for the development of high-end diagnostic reagent industry involved in “precise medical”. Conclusion: With the development of "precise medical" work in China, it brings opportunities for the development of high-end diagnostic products, but also faces many challenges, such as serious shortage of investment in research and development, lack of supporting policies for innovation systems, lags in the revision of national and industry standards, and problems in the quality system. We should speed up the establishment of supporting policies, and strengthen the construction of in vitro diagnostic reagent standards and quality management systems, to build the core competitiveness of "precision medical" , promote the construction of innovation system of diagnostic products and the development of in vitro diagnostic reagent industry of China. |