Abstract: Design and development process of molecular diagnostic reagents is critical to quality management system of in vitro diagnostic reagent. Based on the technical characteristics of molecular diagnostic reagents, the study analyzed the concerned key control points and common problems in the process of design and development from the view of registration quality management system. It aimed at offering technical guidance on design and development process of molecular reagents and registration quality management system to enterprises, thus improving the product development efficiency, optimizing the quality management system, and increasing the efficiency and quality of registration and declaration.