Standard No.:	T/HZFDS 001-2025
Chinese Name:	体外诊断试剂出口质量管理能力评价规范
Professional Classification:	T/    Social Organization Standard
ICS Classification:	03.120.10 03.120.10    Quality management and quality assurance 03.120.10
Source Content Issued by:	Hangzhou Food and Drug Safety Association
Issued on:	2025-03-19
Implemented on:	2025-3-19
Status:	valid
Target Language:	English
File Format:	PDF

本文件规定了体外诊断试剂出口质量管理能力的评价原则、评价内容、评价方法、评价程序和档案管理。
本文件适用于体外诊断试剂出口质量管理能力的评价。