中国标准化Issue(4)：117-122,6.DOI:10.3969/j.issn.1002-5944.2025.04.019
基于高质量发展的广东省医疗器械标准体系构建与应用
Construction and Application of the Medical Device Standards System in Guangdong Province Based on High-quality Development
摘要
Abstract
With the rapid development of the global medical device market and technological advances,Guangdong province,as an important base for the production and research of medical devices in China,faces significant market opportunities and challenges in technological updates.To adapt to international market demands and promote high-quality regional economic development,Guangdong province has actively constructed a comprehensive medical device standards system that covers the entire product life cycle,aligns with international standards,and responds to local characteristics.This system includes foundational general sub-standards,regulatory sub-standards,and new quality productive forces sub-standard systems,aimed at enhancing product quality and safety,promoting technological innovation,and improving industry competitiveness.This paper systematically analyzes the construction process of this standards system and its role in promoting the development of the medical device industry,discusses the challenges and countermeasures in the implementation of standards,and proposes optimization suggestions to support the continuous healthy development of the medical device industry in Guangdong province.With the implementation of this standards system,Guangdong province not only enhances its international competitiveness in medical devices but also contributes to technological innovation and industrial upgrading in the global market.关键词
医疗器械标准体系/高质量发展/国际对接与创新Key words
medical device standards system/high-quality development/international integration and innovation引用本文复制引用
涂荣,闫征,彭晓龙,张颖,李瑶..基于高质量发展的广东省医疗器械标准体系构建与应用[J].中国标准化,2025,(4):117-122,6.基金项目
本文受广东省市场监督管理局科技项目"粤港澳医疗器械科技创新标准化研究与应用"(项目编号:2023CZ03)资助. （项目编号:2023CZ03）
