粤港澳医疗器械技术标准孵化机制研究  

Research on the Medical Device Technical Standards Incubation Mechanism in Guangdong-Hong Kong-Macao Greater Bay Area

作　　者：张颖 涂荣[2] 杨晓峰 闫征 ZHANG Ying;TU Rong;YANG Xiao-feng;YAN Zheng(Guangzhou Institute of Standardization;Guangdong Medical Devices Quality Surveillance and Test Institute)

机构地区：[1]广州市标准化研究院 [2]广东省医疗器械质量监督检验所

出　　处：《中国标准化》2023年第18期72-76,共5页China Standardization

摘　　要：本文讨论了粤港澳大湾区医疗器械技术标准孵化机制的建立和实施,并分析了其重要性和作用。该机制由主管部门、标准制定单位、技术支持单位、市场监管单位和行业协会等组成,旨在提高医疗器械的质量和安全性,增强市场的透明度和公正性,推动医疗器械技术标准的更新和升级。该机制涉及技术评估和标准制定、实验室认证和质量管理、市场推广和宣传以及国际合作和交流等环节。该机制的实施和运作模式可促进医疗器械行业的标准化建设和技术创新,提高医疗器械产品和服务的质量和安全性,促进医疗器械行业的健康发展。This paper discusses the establishment and implementation of the Medical Device Technical Standards Incubation Mechanism in Guangdong-Hong Kong-Macao Greater Bay Area,and analyzes its importance and role.The mechanism consists of competent authorities,standard-setting units,technical support units,market supervision units,and industry associations,aiming to improve the quality and safety of medical devices,enhance market transparency and fairness,and promote the update and upgrade of medical device technical standards.The mechanism involves technical evaluation and standards development,laboratory certification and quality management,market promotion and publicity,as well as international cooperation and communication.The implementation and operation of the mechanism can promote the standardization and technological innovation of the medical device industry,improve the quality and safety of medical device products and services,and promote the healthy development of the medical device industry.

关 键 词：医疗器械 技术标准 孵化机制 

分 类 号：F203[经济管理—国民经济] X321[环境科学与工程—环境工程]