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| 美国和日本医疗器械数据库系统构建思路分析 |
| Analysis on the Construction of Medical Device Database System in America and Japan |
| 投稿时间：2019-07-29 修订日期：2019-10-12 |
| DOI： |
| 中文关键词: 医疗器械，监管，数据库，构建 |
| 英文关键词: Medical devices, Supervision, Database, Construction |
| 基金项目: |
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| 中文摘要: |
| 目的：探讨医疗器械监管先行国家的数据库系统建设思路，为我国医疗器械科学监管提供借鉴和参考。方法：分析美国和日本医疗器械数据库的功能、组织结构、数据信息相联情况，进而探讨其数据库系统的构建思路，对比分析不同数据库的优缺点。结果和结论：各国数据库的构建基于其监管实践，注重数据库系统各层级的分工与互联。基于现代网络技术，监管各方、数据库的各部分之间乃至各国数据库系统之间表现出高效的信息沟通与交换，是医疗器械贸易全球化形势下，数据库系统建设的发展趋势。 |
| 英文摘要: |
| Analyzed the functions, organizational structure, data information and their interconnection and function of the medical device database in the United States, Japan, and then explored the construction concept of these database system. Results and Conclusions: The construction of national databases was based on the regulatory requirement and the information needs of all aspects of services. They paid attention to the cooperation and interconnection of all levels of the database system, and built multi-level and multi-angled multi-dimensional database system structure, and displayed as a friendly search and analysis interface. Using modern network technology to facilitate efficient information communication and data exchange inside or outside the database is a common feature of these database systems. |
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