Standard No.:	DB32/T 4553-2023
English Name:	Guidelines of adverse events monitoring for hospital medical device
Chinese Name:	医疗机构医疗器械不良事件监测工作指南
Chinese Classification:	C00    Standardization and quality management
Professional Classification:	DB    Provincial Standard
Issued by:	Jiangsu Adminstration of Market Regulation
Issued on:	2023-09-22
Implemented on:	2023-10-22
Status:	valid
Language:	English
File Format:	PDF
Word Count:	8500 words
Price(USD):	255.00
Delivery:	via email in 1~3 business day

本文件规定了医疗机构开展医疗器械不良事件监测工作的总则、机构设置、人员配备与职责、工作制度和程序等要求。
本文件适用于二级及以上医疗机构开展医疗器械不良事件监测工作，其他医疗机构开展医疗器械不良事件监测工作时可参照执行。