安徽省医疗器械生产许可检查缺陷项目分析及对策建议

Analysis and Countermeasures on Inspected Defects in Medical Device Manufacturing License in Anhui Province

目的为改进安徽省医疗器械生产企业实施新版《医疗器械生产质量管理规范》提出对策和建议。方法分类汇总安徽省42家次医疗器械生产企业许可现场检查中发现的缺陷,并进行原因分析。结果与结论建立完备的医疗器械生产质量管理体系,强化关键人员培训考核,推进医疗器械产品全生命周期质量风险管理,加强医疗器械生产检查员专业技能培训,可有效防控医疗器械生产过程风险,确保医疗器械产品质量。

Objective To put forward the countermeasures and suggestions for improvement on medical device manufacturing enterprises implementing Good Manufacturing Practice for Medical Devices in Anhui Province.Methods The defects found in the on-site inspection of42medical device manufacturers were summarized,classified and analyzed.Results and Conclusion Through the establishment of a complete medical device manufacturing quality management system,strengthening the training and assessment of key personnel,promoting the risk management of the quality of medical device products in its whole life cycle,and strengthening the professional skills training of medical device production inspectors,which can effectively prevent and control the risk of medical device production process and ensure the quality of medical device products.