Roadmap for implementation of UDI system

Working Group Chair(s)
Laurent Selles
European Union (EU) Regulatory Authorities
European Union
Membership
Regulator and stakeholder membership
Status
Work completed

This item sought to define the path to implementing a globally harmonized approach to a uniform device identification system, and builds on the earlier work of GHTF.

Roadmap for Implementation of UDI System - Update Report 25 September 2012 - PDF (220kb)

Participants

Jackie Elkin
AdvaMed
Jeff Secunda
AdvaMed
Tom Werthwine
AdvaMed

Thomas Hazle
Health Canada

JingLi Li
China Food and Drug Administration (SFDA)
Jun Li
China Food and Drug Administration (SFDA)
Liang Yan
China Food and Drug Administration (SFDA)

Jesus Rueda
European Diagnostic Manufacturers Association (EDMA)

Volker Zeinar
European Confederation of Medical Suppliers Associations (EUCOMED)

Laurent Selles
European Union (EU) Regulatory Authorities
Matthias Neumann
European Union (EU) Regulatory Authorities
Robin Seidel
Federal Institute for Drugs and Medical Devices (BfArM-Germany)

Nicole Denjoy
Global Diagnostic Imaging, Healthcare IT & Radiation Therapy Trade Association (DITTA)
Tracey Holevas
Global Diagnostic Imaging, Healthcare IT & Radiation Therapy Trade Association (DITTA)

Susumu Takahashi
PDMA
Yuko Kitayama
PDMA

Naoki Morooka
Japan Medical Imaging and Radiological Systems Industries Association (JIRA)
Shigetaka Miura
Japan Medical Imaging and Radiological Systems Industries Association (JIRA)
Tatsuo Heki
Japan Medical Imaging and Radiological Systems Industries Association (JIRA)

Joanna Koh
Asian Harmonization Working Party (AHWP) Regulator
Lindsay Tao
Asian Harmonization Working Party (AHWP) Stakeholder
Xuefang Liu
Asian Harmonization Working Party (AHWP) Regulator

Hye-Won Roh
KFDA
Kim
KFDA

Jay Crowley
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)