医用诊断X射线机现场体系考核的思考及建议  

Thinking and Suggestion on the Field System Examination of Medical Diagnostic X-Ray Machine

作　　者：陈卓 黎雁翩 张龚敏 郑海岚 CHEN Zhuo;LI Yan-pian;ZHANG Gong-min;ZHENG Hai-lan(Evaluation and Certification Center of Guangdong Drug Administration,Guangdong Guangzhou 510080;Guangdong Food and Drug Evaluation and Certification Technical Association,Guangdong Guangzhou 510080)

机构地区：[1]广东省药品监督管理局审评认证中心,广东广州510080 [2]广东省食品药品审评认证技术协会,广东广州510080

出　　处：《中国医疗器械信息》2020年第15期3-4,97,共3页China Medical Device Information

摘　　要：新版《医疗器械生产质量管理规范》发布并于2018年1月1日起所有医疗器械生产企业应当符合医疗器械生产质量管理规范的要求。近年来,广东省医疗器械企业申请注册核查数量逐年增加。文章就广东省近几年医用诊断X射线(以下简称DR)注册核查情况进行统计并分析,针对广东省施行新版《医疗器械生产质量管理规范》中存在的主要问题和缺陷提出相应的建议,以便医疗器械监管部门的检查人员、DR生产企业相关人员参考。With the release of the new version of“medical device production quality management standard”,and from January 1,2018,all medical device manufacturers should meet the requirements of the medical device production quality management specification.In recent years,the number of medical device enterprises applying for registration and verification in Guangdong Province has increased year by year.This study makes statistics and Analysis on the registration and verification of medical diagnostic X-ray(hereinafter referred to as DR)in our province in recent years,and puts forward corresponding suggestions for the main problems and defects existing in the implementation of the new version of“medical device production quality management standard”in Guangdong Province,so as to provide reference for inspectors of medical device supervision department and relevant personnel of DR production enterprises.

关 键 词：医用诊断X射线机 现场核查 

分 类 号：R197.39[医药卫生—卫生事业管理]