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Machine Learning-enabled Medical Devices - A subset of Artificial Intelligence-enabled Medical Devices: Key Terms and Definitions

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Artificial Intelligence Medical Devices

A Proposed Document by the International Medical Device Regulators Forum (IMDRF) Artificial Intelligence Medical Devices (AIMD) Working Group is provided below for public comment.

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

Consultation documents

Machine Learning-enabled Medical Devices - A subset of Artificial Intelligence-enabled Medical Devices: Key Terms and Definitions

Please use the comments template to provide comments on the Proposed Documents and send comments to Dr. Young-kyu Kang via e-mail: dbap1231@korea.kr with the subject line 'Public Consultation on Proposed AIMD Working Draft'

Comments - Machine Learning-enabled Medical Devices - A subset of Artificial Intelligence-enabled Medical Devices: Key Terms and Definitions

Member sites

Regional harmonization initiatives

APEC Regulatory Harmonization Steering Committee (RHSC)

Pan American Health Organization (PAHO)

African Medical Devices Forum (AMDF)

South-East Asia Regulatory Network (SEARN)

Official observers

Argentina, National Administration of Drugs, Food and Medical Devices

The World Health Organization (WHO)

Saudi Arabia, Saudi Food and Drug Authority

Affiliate members

Botswana - Botswana Medicines Regulatory Authority (BoMRA)

Chile - Public Health Institute of Chile (ISP)

Chinese Taipei - Taiwan Food and Drug Administration (TFDA)

Colombia - Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA)

Costa Rica - Ministry of Health (MoH)

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)

Ghana - Foods and Drug Authority (Ghana)

India - Central Drugs Standard Control Organization (CDSCO)

Indonesia - Ministry of Health (MoH)

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)

Malaysia - Medical Device Authority (MDA)

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)

Philippines - Food and Drug Administration (FDA)

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

Tanzania - Tanzania Medicines and Medical Devices Authority (TMDA)

Uzbekistan - The Center for Pharmaceutical Products Safety

Zanzibar - Zanzibar Food and Drug Agency (ZFDA)

Zimbabwe - Medicines Control Authority (MCAZ)