2020年~2023年广东省医疗器械抽检的不合格情况分析及相关建议  

Analysis of Failure of Medical Device Sampling and Related Suggestions in Guangdong Province from 2020 to 2023

作　　者：张裕坤 邓力 张玲 韩芝斌 ZHANG Yu-kun;DENG Li;ZHANG Ling;HAN Zhi-bin(Guangzhou Center for Food and Drug Evaluation,Guangdong Guangzhou 510140;The Affiliated Guangdong Second Provincial General Hospital of Jinan University,Guangdong Guangzhou 510315;Guangdong Medical Devices Quality Surveillance and Test Institute,Guangdong Guangzhou 510140)

机构地区：[1]广州市食品药品审评中心,广东广州510140 [2]暨南大学附属广东省第二人民医院,广东广州510315 [3]广东省医疗器械质量监督检验所,广东广州510140

出　　处：《中国医疗器械信息》2024年第21期31-34,共4页China Medical Device Information

摘　　要：目的:聚焦影响医疗器械质量的关键风险点,同时对生产企业和药品监管部门提出了相应的措施和意见建议。方法:采集并整理广东省药品监督管理局官网2020年~2023年通告的医疗器械抽检信息,分析2020年~2023年广东省医疗器械抽检不合格情况。结果:2020年~2023年广东省药品监督管理局共通告了21期医疗器械抽检结果,共抽检7116批医疗器械,其中有11期326批不合格。对抽验结果进行了统计梳理,从产品不合格项目情况和不合格项目类别情况两个维度进行了分析,对医疗器械生产企业和药品监管部门提出了相应的措施和意见建议。结论:医疗器械的抽样检查是监管体系中的关键环节,它成功地串联起医疗器械从注册到生产、经营直至使用的整个法规监管链。药品监管部门应进一步做好审评指导与标准宣贯,加强对问题产品、问题企业的处理。Objective:Focusing on the key risk points affecting the quality of medical devices,and at the same time putting forward corresponding measures and opinions and suggestions to manufacturers and drug regulatory authorities.Methods:Collect and collate medical device sampling and testing information notified on the official website of Guangdong Provincial Drug Administration from 2020 to 2023,and analyse the failure of sampled medical devices in Guangdong Province from 2020 to 2023.Results:From 2020 to 2023,Guangdong Provincial Drug Administration has notified the results of 21 issues of medical device sampling and testing,with a total of 7116 batches of medical devices,of which 326 batches were unqualified in 11 issues.The sampling test results were statistically sorted out and analysed in two dimensions,namely,the situation of unqualified items of products and the situation of unqualified item categories,and corresponding measures and suggestions were proposed to medical device manufacturers and drug regulatory authorities.Conclusion:Sampling inspection of medical devices is a key link in the regulatory system,successfully linking the entire regulatory chain of medical devices from registration to production,operation,and use.The drug regulatory authorities should further provide guidance on evaluation and promote standards,and strengthen the handling of problematic products and enterprises.

关 键 词：医疗器械 抽样检查 不合格分析 质量状况 

分 类 号：R194[医药卫生—卫生事业管理] R197.39[医药卫生—公共卫生与预防医学]