Consultation closed

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

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Closing date
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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 [at] korea.kr (dbap1231[at]korea[dot]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 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

SAHPRA - South African Health Products Regulatory Authority

TFDA - Taiwan Food and Drug Administration

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

EDA - Egyptian Drug Authority 

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

ISP - Public Health Institute of Chile

CinMED - Institute for Medicine and Medical Devices of Montenegro