论文部分内容阅读
医药企业产品标准备案登记规程一、依据医疗器械、制药机械、医药包装材料、制药用原料 (中间体 )按ＧＢ1系列标准的规定编写企业产品标准草案及标准编制说明。企业产品标准的编写应按照ＧＢ/Ｔ1.1- 2 0 0 0《标准化工作导则 第 1部分 :标准的结构和编写规定》执行。产品技术
Registration Rules for Medical Products Registration Criteria 1. Prepare the draft standard for enterprise products according to the provisions of GB1 series of standards for medical devices, pharmaceutical machinery, pharmaceutical packaging materials and pharmaceutical raw materials (intermediates). Enterprise product standards should be prepared in accordance with GB / T1.1-2000 “Standardization Guide Part 1: Standard Structure and Writing Regulations”. product technologies