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Safety information

The following table provides links to device safety information as published by IMDRF National Competent Authority Report (NCAR) Exchange Members.

IMDRF NCAR Exchange Member Alerts Recalls Other Safety Related Information
1 Australia Alerts Recall actions Medical device incident reporting & investigation scheme (IRIS)
Database of Adverse Event Notifications (DAEN)
Medical devices safety
Medical Devices Safety Update
2 Brazil Alertas    
3 Canada Advisories, Warnings and Recalls - MedEffect Canada Recalls and safety alerts Health Product InfoWatch
Canada Vigilance adverse reaction online database
4 European Union
Austria Official announcements Official announcements  
Belgium Notices for the healtcare professionnals (FSN) Notices for the healtcare professionnals (FSN) VIG-NEWS
Cyprus Field Safety Notice Field Safety Notice Field Safety Notice
Czech Republic Aktuality a informace Bezpečnostní upozornění pro terén Národní informační systém zdravotnických prostředků
Denmark Medicinsk udstyr
Medical devices
Sikkerhedsmeddelelser fra fabrikanter af medicinsk udstyr Medicinsk udstyr
Medical devices
Finland     Incident reporting
France Autres mesures de sécurité Retraits de lots et de produits  
Germany BfArM Recommendations Field Corrective Actions BfArM Recommendations
Ireland Safety Notices Manufacturer's Field Safety Notices  
Italy Avvisi di sicurezza sui dispositivi medici Avvisi di sicurezza sui dispositivi medici Vigilanza
Poland Komunikaty bezpieczeństwa Komunikaty bezpieczeństwa Komunikaty bezpieczeństwa
Portugal Alertas Alertas Vigilância de dispositivos médicos
Spain Alertas de productos Sanitarios Alertas de productos Sanitarios Notas informativas de productos sanitarios
Sweden Nyheter | Läkemedelsverket / Swedish Medical Products Agency (lakemedelsverket.se) Nyheter | Läkemedelsverket / Swedish Medical Products Agency (lakemedelsverket.se)  
The Netherlands Safety Notices Recalls
Manufacturer's Field Safety Notices
Other Safety Related Information
News items on Medical Technology
United Kingdom National Patient Safety Alerts Alerts and recalls for drugs and medical devices
Alerts and recalls for drugs and medical devices - 153 alerts for Field safety notice
Medical devices regulation and safety - Latest documents
5 Japan Safety Information regarding Medical Devices 回収情報(医療機器
Safety Information regarding Medical Devices
PMDA Medical Safety Information
6 Singapore Field Safety Corrective Action reporting
Field Safety Notices:
  • Before 6 January 2020, please click here.
  • On 6 January 2020 or after, please click here.

Medical Device Alerts:
Filter for "Safety Alert" and "Medical Devices" here
  Adverse events reporting of medical devices
Medical devices regulation and safety - Announcements
Filter for "Medical Devices" here
7 USA Safety Communications
Medical Device Bans
List of Device Recalls MAUDE - Manufacturer and User Facility Device Experience