我国医疗器械专业标准化技术委员会建设现状及建议

Discussion on the Current Status and Suggestions toward the Establishment of Medical Device Standardization Technical Committees

目的完善医疗器械专业标准化技术委员会建设,推动医疗器械的标准创新和发展。方法通过对目前有源类医疗器械专业标准化技术委员会组成人员的人数、来源构成及其技术职称等进行统计,分析其组织结构现状。结果与结论现有的医疗器械专业标准化技术委员会的组成基本符合《全国专业标准化委员会管理规定》,但尚需进一步完善。

Objective To improve the establishment of Medical Device Standardization Technical Committees,and to propel innovation and development of medical device standards. Methods To analyze the Current Status towards the establishment of Medical Device Standardization Technical Committees,the quantity,the composition,and the technical title of commission members were counted by a statistical method. Results and Conclusion Basically,the current organization of Medical Device Standardization Technical Committees complies with the Regulations on Management of National Standardization Technical Committees; however,it should be further improved.