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IMDRF terminologies for categorized Adverse Event Reporting (AER): terms, terminology structure and codes (Edition 4) - Annex А (Edition 3), G

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Adverse Event Terminology

A Proposed Document by the International Medical Device Regulators Forum (IMDRF) Medical Device Adverse Event Terminology Working Group is provided below for public comment.

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

Consultation documents

IMDRF terminologies for categorized Adverse Event Reporting (AER): terms, terminology structure and codes (Edition 4) - Draft for Public Consultation
IMDRF terminologies for categorized Adverse Event Reporting (AER): terms, terminology structure and codes (Edition 4) - Annex А (Edition 3) - Draft for Public Consultation
IMDRF terminologies for categorized Adverse Event Reporting (AER): terms, terminology structure and codes (Edition 4) - Annex G - Draft for Public Consultation

Please use the comments template to provide comments on the Proposed Documents and send comments to Mr. Ishikawa via e-mail: imdrf-aewg-chair [at] pmda.go.jp (imdrf-aewg-chair[at]pmda[dot]go[dot]jp) with the subject line 'IMDRF Consultation'

Comments - IMDRF terminologies for categorized Adverse Event Reporting (AER): terms, terminology structure and codes (Edition 4)

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)