广州市2020年第三类医疗器械企业经营许可认证现场检查问题分析  

Analysis of the Defective Items of the On-site Inspection for the Certification of the Third Category of Medical Device Business License in Guangzhou in 2020

作　　者：何羡霞 姜志辉 李健 李康 He Xianxia;Jiang Zhihui;Li Jian;Li Kang(Center for Certification and Evaluation,Guangzhou Food and Drug Administration,Guangzhou 510140,China;Department of Pharmacy,General Hospital of Southern Theatre Command of PLA,Guangzhou 510010,China;Department of Medical Service,General Hospital of Southern Theatre Command of PLA,Guangzhou 510010,China)

机构地区：[1]广州市食品药品监督管理局审评认证中心,广州510140 [2]中国人民解放军南部战区总医院药学部,广州510010 [3]中国人民解放军南部战区总医院卫勤部,广州510010

出　　处：《中国药事》2021年第10期1123-1131,共9页Chinese Pharmaceutical Affairs

基　　金：广州市科技计划项目——老年慢病患者合理用药重点实验室(编号201509010012);军队医学科技青年培育计划孵化项目(编号19QNP041)。

摘　　要：目的:通过对广州市2020年第三类医疗器械企业经营许可认证现场检查结果的分析,指出企业常出现的问题并提出相关建议,促使企业加强医疗器械流通环节的质量管理,进一步促进医疗器械行业的健康发展。方法:以《医疗器械经营质量管理规范现场检查指导原则》为依据,对612份第三类医疗器械企业经营许可认证现场检查结果,采用计量学方法进行分类统计分析。结果:职责与制度方面出现缺陷项目454次;人员与培训方面出现缺陷项目798次;设施与设备方面出现缺陷项目366次;采购、收货与验收方面出现缺陷项目244次;入库、贮存与检查方面出现缺陷项目18次;销售、出库与运输方面出现缺陷项目122次;售后服务方面出现缺陷项目247次。结论:建议企业合理制定质量管理制度,加强全体人员医疗器械相关法律法规的学习、培训和考核,准确理解缺陷内涵,加强企业质量管理内审。除此之外,监管部门也需要严格检查员的准入条件,加强检查员的业务培训和思想建设,重视各种监管手段的创新,共同维护医疗器械的质量可控和安全有效。Objective: Through the analysis of the results of the on-site inspection of the business license certification of the third category medical device enterprises in Guangzhou in 2020, the problems frequently occurred in the enterprises were pointed out and relevant suggestions were put forward to promote enterprises to strengthen the quality management of the circulation of medical device and further promote healthy development of the medical device industry. Methods: Based on the Guidelines for On-site Inspection of Medical Device Operation Quality Management Standards, 612 on-site inspection results of business license certification of the third category medical device enterprises were categorized and statistically analyzed by the metrological method. Results:There were 454 defects in duties and systems;798 defects in personnel and training;366 defects in facilities and equipment;244 defects in procurement, receiving and inspection;18 defects in warehousing, storage and inspection;122 defects in sales, shipping and transportation;and 247 defects in after-sales service. Conclusion: It is recommended that the enterprises should develop quality management systems reasonably, strengthen the study,training and assessment of the staff in medical device related laws and regulations, have a thorough understanding of defects accurately, and strengthen the internal audit of enterprise quality management. In addition, the regulatory authorities also need to strictly enforce the access standards of inspectors, strengthen professional training and ideological construction of inspectors, pay attention to the innovation of various regulatory tools. Enterprises and regulatory authorities should jointly maintain the quality control, safety and effectiveness of medical devices.

关 键 词：医疗器械企业 经营许可认证 现场检查 缺陷项目 

分 类 号：R95[医药卫生—药学]