摘要
目的:医疗器械具有复杂性、特殊性、专业性、涉及门类广等特点,面对医疗器械开放自检及检验市场竞争日益加剧的形势,如何提升检验能力,适应产业的迅速发展,确保检验结果的科学性、公正性、权威性,是各医疗器械检验机构面临的共同挑战。方法:从医疗器械检验面临的挑战、法律法规要求、质量管理体系关注要点等方面进行阐述。结果:通过对报告审核中发现的问题,提出质量改进措施及建议。结论:医疗器械检验机构应持续提升检验能力,发展特色优势领域,积极应对医疗器械快速发展的需要及检验新形势,提质增效,应在医疗器械的质量检验工作中,引入风险管理理念并加强过程控制,从人、机、料、法、环等方面构建起全方位的保障体系,提高检验质量和效率,助力医疗器械高质量发展。
Objective:Medical devices have the characteristics of complexity,particularity,professionalism,and wide range of involvement,faced with the growing competitive situation in the open self-test and inspection market of medical devices,it is a common challenge faced by all medical device inspection institutions,that to enhance inspection capabilities,adapt to the rapid development of the Medical devices industry,and ensure the scientificity,fairness,and authority of inspection results.Methods:In this article,the challenges faced by medical device inspection,legal and regulatory requirements,and the key points of quality management system were described.Results:Quality improvement measures and suggestions were proposed based on the issues identified during the test report review.Conclusion:Medical device inspection institutions should continuously improve their inspection capabilities,develop special advantages,actively respond to the needs of the rapid development of medical devices and the new situation of testing,improve quality and efficiency,should be in the quality inspection work of medical devices,the introduction of risk management concepts and strengthen process control,from the human,machine,material,law,environment and other aspects of the construction of a comprehensive security system to improve inspection quality and efficiency and assist in the high-quality development of medical devices.
作者
章娜
陈鸿波
项新华
李静莉
Zhang Na;Chen Hongbo;Xiang Xinhua;Li Jingli(National Institutes for Food and Drug Control,Beijing 102629,China)
出处
《中国药事》
CAS
2024年第10期1143-1148,共6页
Chinese Pharmaceutical Affairs
关键词
医疗器械
检验报告
质量管理
注册自检
风险管理
medical devices
test report
quality control
registration self-testing
risk control
