欧洲、美国、日本医疗器械标准管理及对我国的启示

Enlightenment for Medical Device Standards Administration in China from Experiences of the EU,the USA and Japan

本文从标准化战略、标准管理体制、标准运行机制、标准实施监督机制及其保障机制等几个方面对欧洲、美国、日本的标准管理工作进行了综述,并分析其对我国医疗器械标准管理的启示。

This paper investigated the different models of medical device standards administration in the EU, the USA and Japan and drew some useful experiences to our country from several aspects, including national standardization strategy, the management system, the operation mechanism of operation, implementation and monitoring, financial security and personel security.