关键词: 技术审评, 信息系统, 任务管理, 数据交互

Abstract: The Medical Device Evaluation Information System refers to an application operating system which uses information technology to embed the legal procedures and process for the review of medical devices intoa computer network system, by which the review process is conducted. With the upcoming release of the new Medical Device Supervision and Administration Ordinance and its related regulations and regulatory documents, the national Medical Device Evaluation Information System will be upgraded in accordance with the new procedures and requirements. Based on such background, in this article we investigated the status of the current national Medical Device Evaluation Information System, and put forward opinions and suggestions for the next step in the construction of the information system, hoping that the amendments to the regulations bring an opportunity to further improve the evaluation information system construction and thus speed up the informationization process of the medical device evaluation in China.

Key words: medical device evaluation, information system, task management, data interaction