Abstract: This paper provides a systematic review of the policies, regulations, and management requirements in the development and use of in vitro diagnostic reagents by healthcare institutions, along with their current implementation status both domestic and international, with a case analysis of the pilot program at Peking Union Medical College Hospital. The Medical Affairs Department of Peking Union Medical College Hospital, serving as the leading and operational management unit, established a multi-department collaborative governance structure and developed a full-lifecycle management model encompassing project selection, manufacturing approach determination, regulatory submission and approval, batch production, and clinical implementation. Under this management model, the hospital successfully completed five projects just within one year, achieving the highest number of project filings nationwide. Economic benefit evaluation of the first approved reagent, which is urgently required by clinical and named as allergen-specific immunoglobulin E detection assay for Fraxinus pennsylvanica pollen, demonstrates that the project realized controllable risk and predictable commercial value, proved that proactive implementation of systematic management model and project systematic construction is the key to successfully advancing laboratory-developed test programs. The experiences provide both theoretical insights and practical guidance for peer medical institutions who will seek to develop and implement selfdeveloped in vitro diagnostic reagents.