IVD Reagents are under the main class of product management and belong to the small class of medical devices’ main class. They are used to determine the diagnosis of disease control after taking samples from human body，and the main components of most of its products are biological biocide. Therefore，it is a subject of continuous practice and exploration of enterprise quality leaders to ensure the quality control and ensure the accuracy of diseases diagnosis. Our country has basically completed the level of clear，complementary four-level regulatory system which consists of regulations，departmental rules，normative documents and guidelines in the field of medical devices currently. With the promulgation and implementation of the supervision and management of medical device operation，it is necessary for enterprises to explore the operation of compliance with the requirements in practice. All medical device enterprises，including diagnostic reagents，must constantly improve their awareness and level of quality management in order to respond to the unannounced inspection of the National Bureau. In the future，with the establishment of the General Bureau of Market Supervision，the inspection will be further strengthened. The enterprises must further improve the enterprise compliance system，improve the quality management level，and enhance their comprehensive competitiveness.