摘要
全球医疗器械协调工作组(Global Harmonization Task Force,GHTF)是一个非官方的国际组织,该协调组致力于交流各国医疗器械监督管理经验,制定各成员国都能接受的法律法规和技术标准,达成相关的基本协议,以推动全球医疗器械产业及医疗水平的发展和提高。本文就医疗器械工作组的成立背景、工作程序、协调成果等展开综述,以期为相关研究者提供借鉴。
Global Harmonization Task Force （GHTF） is a voluntary international group which is intends to construct some basic agreement that could be accepted by most of the members. In this article, the background, working procedure and harmonized progress were briefly described. We also hope this writing could do some favor for related investigators.
出处
《中国医疗器械信息》
2009年第4期55-58,62,共5页
China Medical Device Information
关键词
GHTF
医疗器械
管理体系
GHTF, Medical Device, Quality Management System
