论文部分内容阅读
1、根据“医疗器械管理暂行办法”(一九九一年四月十日国家医药管理局令第5号)第三章的规定,制定本《实施细则》。2、本《实施细则》适用于所有在中国境内生产(包括散件组装)医疗器械产品的企业、事业单位(以下简称单位)。
1. According to the provisions of Chapter 3 of the Interim Measures for the Administration of Medical Devices (Order No. 5 of the Order of the State Administration of Drugs of April 10, 1991), this “Implementation Rules” is formulated. 2. This “Implementation Rules” applies to all enterprises and institutions (hereinafter referred to as “units”) that manufacture (including parts and components) medical device products in China.