Standard No.:	DB32/T 5325-2025
English Name:	Technical guidelines for electronic records in medical device production and inspection
Chinese Name:	医疗器械生产检验电子记录技术指南
Chinese Classification:	C30    Medical apparatus and devices in general
Professional Classification:	DB    Provincial Standard
ICS Classification:	11.040.01 11.040.01    Medical equipment in general 11.040.01
Source Content Issued by:	Jiangsu Adminstration of Market Regulation
Issued on:	2025-12-30
Implemented on:	2026-1-30
Status:	valid
Target Language:	English
File Format:	PDF

本文件给出了医疗器械生产过程中有关生产、检验过程电子化记录的技术指南。
本文件适用于医疗器械注册人、备案人和受托生产企业。
对于本文件未列举的相关业务数据，医疗器械注册人、备案人和受托生产企业可参照本文件的相关内容，基于风险并按照同等原则执行电子记录。