Unique Device Identification (UDI) Application Guide

Working Group Chair(s)
Salvatore Scalzo
European Commission
European Union
Membership
Regulator and stakeholder membership (membership to be advised)
Status
Work completed

The purpose of this Work Item is to promote a globally harmonized approach to the application of a UDI system, supporting the principles laid down in the general IMDRF UDI Guidance Document (IMDRF/WG/N7Final:2013). The Work Item is, therefore, intended to contribute to the achievement of the perceived benefits of UDI for regulators and stakeholders implementing UDI around the globe

The working group will develop an IMDRF Technical Document that will provide an Application Guide for UDI providing guidance (definition, instruction, context, etc.) needed for a globally harmonized approach to the application of a UDI system.

  • Harmonized Unique Device Identification (UDI) Application Guide

Unique Device Identification system (UDI System)
UDI System for Medical Devices

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

World Health Organization (WHO)

Swissmedic

 

Affiliate members

 

Chile - Public Health Institute of Chile (ISP)

Chinese Taipei Taiwan Food and Drug Administration (TFDA)

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

Egypt - Egyptian Drug Authority  (EDA)

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

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

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

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