2017~2020年上海市对医疗器械生产企业组织开展质量管理体系第三方评估情况分析

Analysis of Third-Party Evaluation of Quality Management System for Medical Device Manufacturers in Shanghai from 2017 to 2020

作为探索社会共治的实现方式之一,上海市药品监管部门学习欧美先进经验,引入国际知名第三方认证机构对医疗器械生产企业开展质量管理体系评估。该项创新性工作已进入第5年。为全面评估第三方认证机构评估效果,本文从多个维度对2017~2020年连续4年开展的第三方评估进行数据分析。分析结果显示,第三方评估在提高企业质量管理水平、发现隐患和防控风险等方面发挥了重要作用,为后续医疗器械上市后监管风险防控决策提供了参考。

As a means of social co-governance and by learning from the US and European experience,Shanghai Medical Products Administration authorized internationally renowned third-party certification bodies to carry out quality management system evaluation for medical device manufacturers.This innovative work has entered its fifth year.In order to comprehensively evaluate the effect of third-party audit,this article analyzes the evaluation data from 2017 to 2020 from different angles.The results show that third-party evaluation played an important role in helping manufacturers improve quality management system and identify risks,as well as in informing risk control decision-making in medical device post-market surveillance.