核酸分子杂交仪安全有效性评价  

Safety and Effectiveness Evaluation of Nucleic Acid Molecular Hybridization Instrument

作　　者：李小江 梁春滢 LI Xiao-jiang;LIANG Chun-ying(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》2021年第11期13-14,33,共3页China Medical Device Information

摘　　要：核酸分子杂交仪利用碱基互补原则对核酸分子进行杂交,在分子诊断领域应用广泛。目前,该类产品尚无相关标准、指南性文件可参考。文章从医疗器械注册技术审评角度对该产品的安全性、有效性进行探讨,旨在从产品概述、研究资料、风险管理、产品技术要求、临床评价、说明书方面为注册申请人申请产品注册提供指导,同时也为相关技术审评人员提供参考。The hybridization of nucleic acid molecules by using the principle of base complementary is widely used in molecular diagnosis.At present,there are no relevant standards and guidance documents for reference.This paper discusses the safety and effectiveness of the product from the perspective of technical review of medical device registration,aiming to provide guidance for the registration applicant to apply for product registration from the aspects of product overview,research data,risk management,product technical requirements,clinical evaluation and instructions,and also provide reference for relevant technical review personnel.

关 键 词：核酸分子杂交 技术审评 

分 类 号：TH776[机械工程—仪器科学与技术]