| 摘要: |
| 目的
介绍国外大型医用设备管理的经验，为完善大型医用设备管理办法提供借鉴。方法 通过浏览各国卫生部或相关部门的官方网站，并通过Google Scholar搜索引擎检索国外大型医用设备管理的相关信息。结果 荷兰和日本等国的市场准入机制、欧盟的上市后监控和警戒系统、加拿大的缺陷设备召回机制、美国的需要许可证制度（CON）都是行之有效的大型医用设备管理经验。结论 国外大型医用设备管理的市场准入、上市后监管和缺陷设备召回、政府强制审核和规范配置程序等管理经验，可以为新一轮医改中进一步完善大型医用设备管理提供参考。 |
| 关键词: 大型医用设备 管理经验 政府许可机制 |
| DOI： |
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| 基金项目: |
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| Experience of Major Medical Equipment Management of Foreign Countries and its Significance for China |
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| Abstract: |
| Objective To introduce experience of major medical equipment management of foreign countries and provide reference for the perfection of major medical equipment management in China.Methods Information related to major medical equipment management were collected by browsing web sites of ministry of health or other in charge departments of several development countries and searching related information through Google Scholar search engine.Results The market access system of the Netherlands and Japan，etc，the monitoring and warning system for marketing equipments of EU，the recall mechanism for defective equipments of Canada，and the Certificate of Need System (CON) of the United States are all effective management experience for major medical equipment.Conclusion Management experience of market access system，marketing equipment monitoring and warning system，recall mechanism，as well as government’s mandatory review and regulation of equipment configuration procedures can be the reference for the improvement of major medical equipment management in the new round of health reform in China. |
| Key words: major medical equipment,management experience,government permission mechanism |
