论文部分内容阅读
由于医疗器械种类繁多、学科跨度大、技术含量高、使用范围广、产品风险差异大,其生产比一般产品更加复杂,近年来随着开放性经济的飞速发展,出现了更多医疗器械的跨境使用和国际性的医疗行为,监管任务也更加艰巨。如何科学化、系统化地进行医疗器械的全球性管理,实现产品可追溯、患者可知情、政府可监督,是该领域面临的重要课题。医疗器械领域迫切需要全球化的唯一标识体系,提升物流供应链效率,降低流通成本,使医疗不良事件更快通过追溯处理追责,从而保障患者的生命健康和切身利益。
As a wide range of medical devices, subjects span large, high-tech, wide range of use, product risk differences, its production more complex than the average product in recent years with the rapid development of open economy, there have been more cross-medical devices Habitat use and international medical behavior, regulatory tasks are more difficult. How to scientifically and systematically conduct the global management of medical devices and make the products traceable, the patients can be informed and the government can supervise are the important topics in this field. The medical device field urgently needs the unique identification system of globalization to enhance the efficiency of the logistics supply chain and reduce the circulation cost so that medical adverse events can be dealt with retrospectively and quickly to ensure the health and vital interests of patients.