本文对全球医疗器械命名系统(GMDN)的发展和历史情况作了清晰的概括,对全球医疗器械命名取得的成果,以及全球医疗器械命名的一般规则进行了介绍。伴随着全球医疗器械命名的国际化进程,作者回顾了中国医疗器械命名的探索过程,以及推进中国医疗器械命名工作存在的问题、困难、争议和所取得的成果。本文对于国际化医疗器械命名数据库(UMDN)的选择提出自己的看法,对医疗器械命名工作将推动中国医疗器械分类、注册和采购管理提出了建议。
<<The author has summarized the progress of the Global Medical Device Nomenclature (GMDN) with its fruitful outcome,and has described the general rules of GMDN. The author has reviewed the exploring of Chinese medical device nomenclature (CMDN) with the problems,difficulties and the hot points from public during the project moving under the GMDN harmonization. The author has raised his own opinion in terms of UMDN’s alternative. Meanwhile,he has given the advice on improving Chinese medical device classification,registration and hospital purchase management system by CMDN.
<<Keywords: | Medical DeviceGlobalNomenclature |