Consultation closed

Principles and Practices for Software Bill of Materials for Medical Device Cybersecurity

Start date
Closing date
Working group
Medical Device Cybersecurity Guide

A Proposed Document by the International Medical Device Regulators Forum (IMDRF) Medical Device Cybersecurity Guide Working Group is provided below for public comment.

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

Consultation documents

Principles and Practices for Software Bill of Materials for Medical Device Cybersecurity.docs
Principles and Practices for Software Bill of Materials for Medical Device Cybersecurity.pdf

Please use the comments template to provide comments on the Proposed Document and send comments to Dr. Aftin Ross via email: aftin.ross [at] fda.hhs.gov (aftin[dot]ross[at]fda[dot]hhs[dot]gov) with the subject line 'Public Consultation on Proposed MDCG SBOM Working Draft'.

Comments - Principles and Practices for SBOM for Medical Device Cybersecurity.doc

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)