Biovigilance is a framework for the detection, collection and analysis of information on unexpected and untoward occurrences associated with the use of medical products of human origin (MPHO). Biovigilance and surveillance systems monitor adverse events, thereby promoting the implementation of preventive and corrective measures. The Council of Europe′s Guide to the Quality and Safety of Organs for Transplantation (8th Edition) provides a practical overview of this topic, discusses the establishment of effective biovigilance and surveillance systems, explores the practical steps of biovigilance, and analyzes the specific processes, methods, and importance of each link. It aims to provide theoretical support and practical guidance for medical workers, managers, and health management departments from various organ procurement organizations and transplant centers to optimize the surveillance system for organ transplantation, reduce risks, and ensure the safety and quality of transplantation.