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A review of the NCAR system

The NCAR Exchange Program facilitates the exchange of relevant post market safety information on medical devices with global distribution. The aim is to trigger rapid adoption of field safety corrective actions in all concerned geographies to avoid death or serious deterioration of health, when relevant.

This work will review the current arrangements and advise on opportunities for improvement and possible expansion of the system

Working Group Chair: Jean-Francois Roche (European Union) contact Jean-Francois.Roche@ec.europa.eu

Working Group Membership: Regulator only

Australia

  • Pam Carter
    Director
    Device Vigilance and Monitoring Section
    Office of Product Review
    Therapeutic Goods Administration (TGA)

Brazil

  • Stela Candioto Melchior
    Health Surveillance Specialist
    National Health Surveillance Agency (ANVISA)
  • Maria Gloria Vicente
    Health Surveillance Specialist National Health Surveillance Agency (ANVISA)
  • Guillerme Buss
    Health Surveillance Specialist
    National Health Surveillance Agency (ANVISA)

Canada

  • Barbara Harrison
    Senior Corporate Regulatory and Enforcement Adviser
    Regulatory Operations and Regions Branch
    Health Canada

European union

  • Jean-Francois Roche (Chair)
    Policy Officer
    Cosmetics and Medical Devices
    European Commission
    Email: Jean-Francois.Roche@ec.europa.eu
  • Ekkehart Stöesslein
    Deputy Head of the Division Medical Devices
    Federal Institute for Drugs and Medical Devices (BfArM-Germany)
  • Carmen Ruiz-Villar
    Head of Service of the Vigilance of Medical Devices Unit
    Spanish Agency for Medicines and Medical Devices (AEMPS-Spain)
  • Andrea Hanson
    Product Manager (Medical Devices)
    Health Products Regulatory Authority (HPRA-Ireland)

Japan

  • Takahata, Masahiro
    Senior Deputy Director
    Office of Safety Promotion
    Safety Division
    Pharmaceutical and Food Safety Bureau
    Ministry of Health Labour and Welfare (MHLW)
  • Dr. Fumitaka Takahashi
    Office of Safety
    Pharmaceuticals and Medical Devices Agency (PMDA)

United States of America

  • Courtney Millin PhD
    Division of Postmarket Surveillance
    Office of Surveillance and Biometrics
    Center for Devices and Radiological Health
    US FDA
  • Nancy Pressley
    Associate Division Director
    Division of Postmarket Surveillance
    Office of Surveillance and Biometrics
    Center for Devices and Radiological Health
    US FDA

IMDRF Official Observers and Affiliate Organization Representatives

  • Mr Essam Al Mohandis
    AHWP Representative