国家医疗器械监督抽检产品质量安全风险点分析

Risk Point Analysis of Product Quality and Safety in Sample Inspection of National Medical Device Supervision

该文梳理了近年国家医疗器械监督抽检中发现的医疗器械质量安全风险点,将这些风险点归纳到质量管理体系、产品技术要求、国家标准行业标准等方面,并进一步归纳出若干种具体风险情形,基于以上努力构建了一个较为全面的风险点体系,再以典型实例进行说明,且针对存在的问题向生产企业和监管部门分别提出了相应建议。

This paper reviews the quality and safety risk points of medical devices found in the sampling inspection of national medical device supervision in recent years.These risk points are summarized into quality management system,product technical requirements,national standards and industry standards,etc.Several specific risk scenarios are further summarized.Based on the above efforts,a more comprehensive risk point system is constructed.Then it is illustrated with typical examples.In view of the existing problems,the corresponding suggestions are put forward to the production enterprises and supervision departments respectively.