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)

Member sites

Regional harmonization initiatives

APEC LSIF Regulatory Harmonization Steering Committee

Global Harmonization Working Party (GHWP)

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

Switzerland, Swissmedic

Affiliate members

Botswana - Botswana Medicines Regulatory Authority (BoMRA)

Chile - Public Health Institute of Chile (ISP)

Chinese Taipei Taiwan Food and Drug Administration (TFDA)

Costa Rica - Ministry of Health

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)

India - Central Drugs Standard Control Organization (CDSCO)

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)

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)

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

Tanzania - Tanzania Medicines and Medical Devices Authority (TMDA)

Zimbabwe - Medicines Control Authority (MCAZ)