三种通过互联网销售的医疗器械质量监测情况分析

Analysis on Quality Monitoring of Three Kinds of Medical Devices Sold on the Internet

目的:分析互联网销售医疗器械的质量特点,总结监测发现的问题和现象,探索互联网平台开展所售医疗器械质量监测的管理模式。方法:对三种通过互联网销售的医疗器械进行抽样检验,对检验情况开展数量统计,对统计结果使用描述性研究法和经验总结法进行分析。结果:建立了互联网平台履行质量安全监测义务和网络销售违法行为制止及报告义务的一种模式,提出加强互联网销售医疗器械监管的若干建议。结论:应高度重视互联网销售医疗器械的监管,引导企业履行主体责任,加强对包装标签说明书和进口医疗器械的监管。

Objective: To analyze the quality characteristics of medical devices sold on the Internet, to summarize the problems and phenomena found in monitoring, and to explore the management mode of quality monitoring of medical devices sold on Internet platform. Methods: Three kinds of medical devices sold on the Internet were sampled and tested. The results were counted and analyzed by descriptive research method and experience summary method. Results: A pattern of Internet platform to fulfill the quality and safety monitoring obligations and the obligation to stop and report illegal acts of network sales were established. Some suggestions for strengthening the supervision of Internet sale of medical devices were put forward. Conclusion: The supervision of the Internet sale of medical devices should be highly emphasized. Enterprises should be guided to fulfill their main responsibilities. The supervision of packaging, labeling specifications and imported medical devices should be strengthened.