Consultation open

Medical Device Software: Considerations for Device and Risk Characterization

Start date
Closing date
Working group
Software as a Medical Device (SaMD)

A Proposed Document by the International Medical Device Regulators Forum (IMDRF), Software as a Medical Device Working Group, is provided below for public comment. 

Thank you for your contribution in reviewing and providing feedback for this document. 

Consultation documents

Medical Device Software: Considerations for Device and Risk Characterization

Please use the comments template to provide comments on the Proposed Document and send comments to email: IMDRFSaMDWG [at] fda.hhs.gov (IMDRFSaMDWG[at]fda[dot]hhs[dot]gov) with the subject line ''Public Consultation on Medical Device Software: Considerations for Device and Risk Characterization" 

Comments - Medical Device Software: Considerations for Device and Risk Characterization

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)