摘要
医疗器械团体标准不同于医疗器械标准。本文梳理了医疗器械团体标准的数量及规模,对其发展的现状进行分析,探索了影响其良好发展的3个因素:定位不明确、制度不完善,实施效果不明显。本文认为医疗器械团体标准的发展离不开制度的引导和规范,市场的开放与支持。
Social organization standard for medical device is different from medical device standard.This paper sorts out the number and scale of social organization standard for medical device,analyzes the current situation of its development,and explores three factors affecting its sound development:unclear positioning,imperfect system,and insignificant implementation effect.This paper argues that the development of social organization standard for medical device cannot be separated from the guidance and regulation of the NMPA,and the opening and support of the market.
作者
陆离原
叶莎莎
LU Li-yuan;YE Sha-sha(Shanghai Testing and Inspection Institute for Medical Devices)
出处
《中国标准化》
2020年第S01期90-93,共4页
China Standardization
关键词
医疗器械
团体标准
发展现状
制约因素
medical device
social organization standard
development status
restrictive factors
