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目的阐述北京市医疗器械技术审评信息化建设的一些难点,为今后医疗器械技术审评信息化建设的开展提供一些借鉴和几点思路。方法梳理现阶段北京市医疗器械技术审评信息化建设情况。结果与结论医疗器械技术审评信息化建设需要一个循序渐进的过程,利用现有资源,处理好开发与收效的关系,解决目前最关注的问题,是找准定位的关键,是加快信息化建设切实有效的途径。整合已有信息化资源,建立综合化、规范化、人性化、智能化和可持续发展的医疗器械技术审评信息化支撑体系将是今后发展的趋势。
Objective To explain some difficulties in the informatization construction of medical device technology review in Beijing and to provide some references and ideas for the future development of medical device technology review and information construction. Methods combing the current stage of Beijing Medical Device Technical Review of information technology. Results and Conclusion The construction of information technology for medical device review requires a step by step process. The use of available resources to properly handle the relationship between development and yield and to solve the problems of greatest concern at present is the key to pinpoint the positioning and speed up the construction of informatization Effective way. Integration of existing information resources, the establishment of integrated, standardized, humane, intelligent and sustainable development of medical equipment technical review of information technology support system will be the future trend of development.