Safety information

The following table provides links to device safety information as published by IMDRF Management Committee Members and Official Observers.

IMDRF MC Members

 
 AlertsRecallsOther Safety Related Information
AustraliaAlertsRecall actionsMedical device incident reporting & investigation scheme (IRIS)
Database of Adverse Event Notifications (DAEN)
Medical devices safety
Medical Devices Safety Update
BrazilAlerts - AnvisaRecall actionsTechnovigilance
CanadaAdvisories, Warnings and Recalls - MedEffect CanadaRecalls and safety alertsHealth Product InfoWatch
Medical Device Incident Database
European Union

Austria

Official announcementsOfficial announcements 

Belgium

Notices for the healtcare professionnals (FSN)Notices for the healtcare professionnals (FSN)VIG-NEWS

Cyprus

Field Safety NoticeField Safety NoticeField Safety Notice

Czech Republic

Aktuality a informaceBezpečnostní upozornění pro terénNárodní informační systém zdravotnických prostředků

Denmark

Medicinsk udstyr
Medical devices		Sikkerhedsmeddelelser fra fabrikanter af medicinsk udstyrMedicinsk udstyr
Medical devices

Finland

  Incident reporting

France

Autres mesures de sécuritéRetraits de lots et de produits 

Germany

BfArM RecommendationsField Corrective ActionsBfArM Recommendations

Ireland

Safety NoticesManufacturer's Field Safety Notices 

Italy

Avvisi di sicurezza sui dispositivi mediciAvvisi di sicurezza sui dispositivi mediciVigilanza

Poland

Komunikaty bezpieczeństwaKomunikaty bezpieczeństwaKomunikaty bezpieczeństwa

Portugal

AlertasAlertasVigilância de dispositivos médicos

Spain

AlertasAlertasNotas informativas de productos sanitarios

Sweden

Nyheter | Läkemedelsverket / Swedish Medical Products Agency (lakemedelsverket.se)Nyheter | Läkemedelsverket / Swedish Medical Products Agency (lakemedelsverket.se) 

The Netherlands

Safety NoticesManufacturer's Field Safety NoticesNews items on Medical Technology
JapanSafety Information regarding Medical Devices回収情報（医療機器
Safety Information regarding Medical Devices		PMDA Medical Safety Information
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
South Koreahttps://emedi.mfds.go.kr/recall/MNU20265http://emedi.mfds.go.kr/abcs/MNU20268
Switzerlandhttps://www.swissmedic.ch/swissmedic/en/home/medical-devices/overview-medical-devices/archive/warnungen.htmlhttps://fsca.swissmedic.ch/mep/#/

https://www.swissmedic.ch/swissmedic/en/home/medical-devices/overview-medical-devices/archive/faelschungen.html

https://www.swissmedic.ch/swissmedic/en/home/medical-devices/overview-medical-devices/information-on-specific-medical-devices.html

United KingdomNational Patient Safety AlertsAlerts 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
USASafety Communications
Medical Device Bans		List of Device RecallsMAUDE - Manufacturer and User Facility Device Experience

 

IMDRF Official Observers

 
 AlertsRecallsOther Safety Related Information
World Health Organization (WHO)  https://www.who.int/teams/regulation-prequalification/incidents-and-SF/safety-information-for-medical-devices-including-in-vitro-diagnostics

Member sites

Regional harmonization initiatives

APEC Regulatory Harmonization Steering Committee (RHSC)

Pan American Health Organization (PAHO)

African Medical Devices Forum (AMDF)

Official observers

Argentina, National Administration of Drugs, Food and Medical Devices

The World Health Organization (WHO)

Saudi Arabia, Saudi Food and Drug Authority

Affiliate members

Botswana - Botswana Medicines Regulatory Authority (BoMRA)

Chile - Public Health Institute of Chile (ISP)

Chinese Taipei - Taiwan Food and Drug Administration (TFDA)

Colombia - Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA)

Costa Rica - Ministry of Health (MoH)

Cuba - Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos (CECMED)

Dominican Republic - General Directorate of Medicines, Food and Health Products (DIGEMAPS)

Egypt - Egyptian Drug Authority  (EDA)

El Salvador - Sanitary Regulation Superintendency (SRS)

Ethiopia - Ethiopian Food and Drug Authority (EFDA)

Ghana - Foods and Drug Authority (Ghana)

India - Central Drugs Standard Control Organization (CDSCO)

Indonesia - Ministry of Health (MoH)

Israel - The Medical Technology, Health Information, Innovation and Research Directorate (MTIIR)

Affiliates

 

Jordan - Jordan Food and Drug Administration (JFDA)

Kenya - Pharmacy and Poisons Board (PPB)

Malaysia - Medical Device Authority (MDA)

Mexico - Federal Commission for Protection from Sanitary Risks (COFEPRIS)

Montenegro - Institute for Medicine and Medical Devices of Montenegro (CINMED)

Nigeria - National Agency for Food and Drug Administration Control (NAFDAC)

Oman - Drug Safety Center, Medical Device Control Department (DSC)

Paraguay - National Health Surveillance (DINAVISA)

Peru - General Directorate of Medicines, Supplies and Drugs (DIGEMID)

Philippines - Food and Drug Administration (FDA)

South Africa - South African Health Products Regulatory Authority (SAHPRA)

Tanzania - Tanzania Medicines and Medical Devices Authority (TMDA)

Uzbekistan - The Center for Pharmaceutical Products Safety

Zanzibar - Zanzibar Food and Drug Agency (ZFDA)

Zimbabwe - Medicines Control Authority (MCAZ)