国家医疗器械技术审评信息系统建设之思考

医疗器械技术审评信息系统是指运用信息化手段,将医疗器械审评法定程序与流程固化在计算机网络系统中,并以此为载体进行技术审评的一种应用操作系统。随着新版《医疗器械监督管理条例》及其相关规章与规范性文件即将发布实施,国家医疗器械技术审评信息系统也将根据新的程序和要求进行升级改造。本文在上述背景下对现行国家医疗器械技术审评信息系统的现状以及存在的主要问题进行了分析,并对下一步信息系统的建设提出了意见和建议,旨在以此次法规修订为契机进一步完善审评信息系统建设,进而加快我国医疗器械审评信息化的进程。

Thoughts on National Medical Device Evaluation Information System Construction

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 into a 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.