中国医疗器械分类技术委员会工作机制探究

On the Operation Mechanism of Chinese Medical Device Classification Technical Committee

目的:探究医疗器械分类技术委员会工作机制,为公众用械安全和推进医疗器械分类管理改革提供参考。方法:从系统工程角度,分析组织结构的层级和跨度、横向和纵向分工,确定医疗器械分类技术委员会架构设置与构建原则;根据医疗器械风险评价依据的要素、专业领域覆盖要求、监管工作稳定性连续性等多个方面要求而确定专家结构与遴选原则,并且分析了其运行机制和管理模式。结果与结论:通过组建专业结构合理、管理规范、稳定运行的专家支撑机构,完善医疗器械分类工作机制,为进一步提高医疗器械分类的科学性提供支持。

Objective： To explore the operating mechanism of the Medical Device Classification Technical Committee, and to provide references for reducing the risk of using medical devices and promoting reform on classification management of medical devices. Methods： By analyzing the level and span of organizational structure, principle of division, from the view of the system engineering, and the constructive principles of the Medical Device Classification Technical Committee were determined. Meanwhile, according to the elements of risk assessment on medical devices, the field of experts, continuity of supervision policies and so on, the principles of selecting experts were determined, and the operating mechanism and management mode were analyzed. Results and Conclusions： By establishing a stable expert team with reasonable structure and standardized management, the operating system of medical device classification can be improved, and the scientificity of medical-deviceclassification can be enhanced.