我国医疗器械装备管理发展较晚,相关的管理体制仍然不够健全,质量风险管理仍需要进一步完善。本文阐述了医疗器械装备管理中出现的漏洞和缺点,明确了医疗器械装备管理体系构建的原则,提出了医疗器械装备管理体系的策略,以期为新时期加强医疗器械的装备管理提供参考。 China’s medical equipment and equipment management development is late, the relevant management system is still not sound enough, the quality of risk management still needs further improvement. This article expounds the loopholes and shortcomings in the management of medical equipment and equipment, defines the principles of the construction of medical equipment and equipment management system and puts forward the strategy of medical equipment and equipment management system in order to provide reference for strengthening the management of medical equipment in the new era.