美国医疗器械认可共识标准管理体系研究

Research on the Management System of Medical Device Recognized Consensus Standards in USA

该文简要介绍了美国医疗器械认可共识标准的发展历程、认可工作程序以及认可共识标准清单的基本情况,初步分析了美国医疗器械认可共识标准管理体系的经验,为完善我国医疗器械标准管理体系提供借鉴和参考。

This paper gives a brief introduction on the development of recognized consensus standards,the recognition working procedure and the overview of medical devices recognized consensus standards in USA,and analyzes the experience of the recognition management system in USA,aiming at providing a reference for the improvement of the medical device standard management system in China.