【CODEX】2014 No.650 医疗器械监督管理条例（3-4）-EN
第三章医疗器械生产
Chapter III Medical Device Manufacturing
第二十条 从事医疗器械生产活动，应当具备下列条件：
Article 20. The entities engaged in the manufacturing of medical devices shall meet the following requirements:
(一) 有与生产的医疗器械相适应的生产场地、环境条件、生产设备以及专业技术人员；
(1) Equipped with manufacturing site, environmental conditions, manufacturing equipment, and technical professionals suitable for the medical device manufacturing;
(二) 有对生产的医疗器械进行质量检验的机构或者专职检验人员以及检验设备；
(2) Equipped with quality inspection department or full-time inspectors and inspection equipment for the manufactured medical device;
(三) 有保证医疗器械质量的管理制度；
(3) Equipped with management system to guarantee the quality of manufactured medical devices;
(四) 有与生产的医疗器械相适应的售后服务能力；
(4) Equipped with after-sale capacities suitable for the manufactured medical device;
(五) 产品研制、生产工艺文件规定的要求。
(5) Other requirements defined in the documents for product research and development, and manufacturing technologies.
