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IMDRF Terminologies for Categorized Adverse Event Reporting (AER): terms, terminology structure and codes

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Adverse Event Terminology

A Proposed Document has been released by the International Medical Device Regulators Forum (IMDRF) Adverse Events Terminology Working Group. This includes the proposed third edition of Document N43 and its Annex E & F

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

Consultation documents

N43 Edition 3 - IMDRF terminologies for categorised Adverse Event Reporting (AER): terms, terminology, structure and codes
N43 Edition 3 - Annex E Health Effect - Clinical Signs, Symptoms and Conditions Terms and Codes
N43 Edition 3 - Annex F Health Effect - Health Impact Terms and Codes

Please use the Working Group's comments template in Excel Format for public consultation, with reference to the Instruction for commenting, to provide comments on the Proposed Document and email comments to imdrf-aewg-chair [at] pmda.go.jp (imdrf-aewg-chair[at]pmda[dot]go[dot]jp).

Comments template - N43 Edition 3 - IMDRF terminologies for Categorized Adverse Event Reporting (AER): terms, terminology, Structure and Codes, and Annex E and F
Instructions for commenting

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)