Technical document

Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations

IMDRF Code
IMDRF/SaMD WG/N12
Published date
Status
Final
IMDRF code: IMDRF/SaMD WG/N12FINAL:2014
Published date:
Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations

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