全球医疗器械不良事件监测发布查询路径
来源:中国医疗器械行业协会
2020/8/19 20:20:40

中国-国家药品不良反应监测中心发布:

中国-《医疗器械不良事件信息通报》

http://www.cdr-adr.org.cn/ylqx_1/Medical_aqjs/Medical_aqjs_xxtb/

中国-《医疗器械警戒快讯》

http://www.cdr-

adr.org.cn/ylqx_1/Medical_aqjs/Medical_aqjs_jjkx/

美国-不良事件查询数据库MAUDE

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm

美国-召回查询数据库Recall

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm

美国-按年份查询警告信(warning letter)

https://www.fda.gov/drugs/enforcement-activities-fda/warning-letters-and-notice-violation-letters-pharmaceutical-companies

英国-医疗器械警报(MHRA)

https://www.gov.uk/drug-device-alerts?keywords=&alert_type[]=devices&issued_date[from]=&issued_date[to]=


加拿大-召回和警戒

https://healthycanadians.gc.ca/recall-alert-rappel-avis/index-eng.php

 

澳大利亚TGA-不良事件

https://apps.tga.gov.au/prod/DEVICES/daen-entry.aspx

澳大利亚TGA-召回

http://apps.tga.gov.au/PROD/SARA/arn-entry.aspx

澳大利亚TGA-警戒

https://www.tga.gov.au/all-alerts

日本PMDA

https://www.pmda.go.jp/english/safety/info-services/devices/0002.html


德国BfArM-发布FSCAs(Field Corrective Actions)

https://www.bfarm.de/SiteGlobals/Forms/Suche/EN/kundeninfo_Filtersuche_Formular_en.html?nn=4527724