A review of the NCAR system

Working Group Chair(s)
Jean-Francois Roche
European Commission
European Union
Membership
Regulator only
Status
Work completed

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.

Revision of the NCAR Exchange Program - PDF (66kb)

Participants

Pam Carter
Therapeutic Goods Administration (TGA)

Guillerme Buss
Brazilian Health Regulatory Agency (ANVISA)
Maria Gloria Vicente
Brazilian Health Regulatory Agency (ANVISA)
Stela Candioto Melchior
Brazilian Health Regulatory Agency (ANVISA)

Barbara Harrison
Health Canada

Andrea Hanson
Health Products Regulatory Authority (HPRA), Ireland
Carmen Ruiz-Villar
Spanish Agency for Medicines and Medical Devices (AEMPS-Spain)
Ekkehart Stöesslein
Federal Institute for Drugs and Medical Devices (BfArM-Germany)
Jean-Francois Roche
European Commission

Essam Al Mohandis
Asian Harmonization Working Party (AHWP) Representative

Fumitaka Takahashi
Pharmaceuticals and Medical Devices Agency (PMDA)
Masahiro Takahata
Ministry of Health, Labour and Welfare (MHLW)

Courtney Millin
Food and Drug Administration (US FDA)
Nancy Pressly
Food and Drug Administration (US FDA)