Consultation closed

Unique Device Identification system (UDI System)

Start date
Closing date
Working group
Unique Device Identification (UDI) Application Guide

A Proposed guidance Document has been released by the International Medical Device Regulators Forum (IMDRF) UDI Working Group, as well as two Information documents on UDI.

Thank you for your contribution aiming at the validation of the IMDRF documents.

Consultation documents

N48 - Unique Device Identification system (UDI system) Application Guide
N53 - Use of UDI Data Elements across different IMDRF Jurisdictions
N53 - Annex - Use of UDI Data Elements across different IMDRF Jurisdictions
N54 - Recording Unique Device Identifiers in Electronic Health Sources

Please use the comments templates to provide comments on the Proposed Documents and email comments to salvatore.scalzo [at] ec.europa.eu (Salvatore Scalzo).

Comments - N48 - IMDRF UDI Application Guide
Comments - N53 - Use of UDI Data Elements across different IMDRF Jurisdictions
Comments - N54 - Recording Unique Device Identifiers in Electronic Health Sources

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)