技術要求撰寫
Technical requirement preparation 　　

服務內容：

根據產品分類及功能原理，提供技術要求編寫依據標準、法規咨詢與輔導； 　　

資深專家一對一產品技術要求編制輔導；

千套技術要求模板提供，為企業節約產品上市時間。

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. 　　

注冊人準備資料：

產品說明書（至少包括：產品照片、型號規格、結構原理特性、性能參數、材料特性、滅菌方式（無菌適用）、國內外已上市產品的比較等）。 　　

主要原材料資料（主要原材料的來源、制備、質控指標，或者供應商提供的質量標準、出廠檢定報告以及原材料到貨后的質量檢驗資料）； 　　

產品的性能指標及檢驗方法； 　　

生產工藝（工藝流程圖（須注明主要控制點，即關鍵工序和特殊工序）主要組分的具體生產過程）。

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).