技术要求撰写
Technical requirement preparation 　　

服务内容：

根据产品分类及功能原理，提供技术要求编写依据标准、法规咨询与辅导； 　　

资深专家一对一产品技术要求编制辅导；

千套技术要求模板提供，为企业节约产品上市时间。

Service content ：

According to product classification and functional principles, provide technical requirements according to standards, regulatory consultation and guidance;

Senior experts one-to-one product technical requirements preparation counseling;

thousands of sets of technical requirements templates are provided to save product market time for enterprises. 　　

注册人准备资料：

产品说明书（至少包括：产品照片、型号规格、结构原理特性、性能参数、材料特性、灭菌方式（无菌适用）、国内外已上市产品的比较等）。 　　

主要原材料资料（主要原材料的来源、制备、质控指标，或者供应商提供的质量标准、出厂检定报告以及原材料到货后的质量检验资料）； 　　

产品的性能指标及检验方法； 　　

生产工艺（工艺流程图（须注明主要控制点，即关键工序和特殊工序）主要组分的具体生产过程）。

The registrant prepares the information：

Product description (including at least: product photos, model specifications, structural principle characteristics, performance parameters, material characteristics, sterilization method (sterile application), domestic and foreign listed products comparison, etc.).

The main raw material information (the source, preparation, quality control indicators of the main raw materials, or the quality standard provided by the supplier, the factory verification report and the quality inspection data after the arrival of raw materials);

Product performance indicators and inspection methods;

Production process (process flow chart (must indicate the main control points, that is, key processes and special processes) of the main components of the specific production process).