电解质分析仪产品安全有效性研究  

Safety and Effectiveness Research of Electrolyte Analyzer

作　　者：吴林蔚 陈虹蓁 赖锦坝 樊梓蕙 李风梅 王小良 WU Lin-wei;CHEN Hong-zhen;LAI Jin-ba;FAN Zi-hui;LI Feng-mei;WANG Xiao-liang(Center for Certification and Evaluation,Guangdong Drug Administration,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

出　　处：《中国医疗器械信息》2023年第21期12-15,39,共5页China Medical Device Information

摘　　要：根据《医疗器械注册与备案管理办法》《关于公布医疗器械注册申报资料要求和批准证明文件格式的公告》及相关指导原则、国家/行业标准的要求,结合注册申请人的注册申报资料,从注册审评的角度来对电解质分析仪产品的综述和非临床资料、说明书等安全有效性方面进行分析研究,希望对注册申请人注册申报该类产品有所帮助。According to Management Measures for Registration and Filing of Medical Devices,the Announcement on the Publication of Medical Device Registration Application Data Requirements and the Format of Approval Certification Documents and the relevant guiding principles and national/industry standards,combined with the registration application data of the registration applicant,From the perspective of registration review,this paper analyzes and studies the safety and effectiveness of electrolyte analyzer products,non-clinical data and instructions,hoping to help registration applicants register such products.

关 键 词：电解质分析仪 安全有效性 注册审评 

分 类 号：TH776[机械工程—仪器科学与技术]