（档案管理）无源医疗器械技术文档和设计档案材料指南.pdfVIP

（档案管理）无源医疗器械 技术文档和设计档案材料 指南 无源医疗器械技术文件和设计文档指南 Whereas the term “Technical File “ is used for Medical Devices of class I, class IIa and class IIb, the term “Design Dossier “ is used for the class III products. 标题中的“技术文件”适用于I类，IIa类,IIb类医疗器械，“设计文档”适用于III类 医疗器械 Technical Files are retained in the premises of the manufacturer or the Authorized Representative for potential review of Competent Authorities and Notified Body. Part B of the Technical File may be available at the manufacturer only. 技术文件是保留在制造商或授权代表单位的主管部门和认证机构。部分技术文件