Software as a Medical Device

Working Group Chair(s)
Marc Lamoureux
Health Canada
Canada
Sonja Fulmer
Food and Drug Administration (US FDA)
United States of America
Membership
Regulator and Stakeholder Membership
Status
Current

Software for medical purposes continues to be increasingly important and influential in advancing public health. The Software as a Medical Device (SaMD) Working Group (WG) published the last of 4 technical documents it authored in 2017. Since 2017, regulations related to medical purpose software have evolved and the pace and number of technological advancements continue to increase. 

The goal of the SaMD WG is to review and refine, as needed, the previously published documents to ensure ongoing consistency, predictability, transparency, and quality of premarket regulatory programs and criteria for assessing premarket technical documentation for SaMD. The review will also pay attention to post-market activities, recognizing the speed with which digital health technology develops and the value of taking a total product life cycle approach aligned with the principles of IMDRF.

Participants

Bioing. José Médico Orellano
National Administration of Drugs, Food and Medical Devices (ANMAT)
Carolina Magnatti
National Administration of Drugs, Food and Medical Devices (ANMAT)
Sebastián Ocampo
National Administration of Drugs, Food and Medical Devices (ANMAT)

Dr David Hau
Therapeutic Goods Administration (TGA)
Lesley-Anne Farmer
Therapeutic Goods Administration (TGA)

Mr Francisco Iran Cartaxo Barbosa
Brazilian Health Regulatory Agency (ANVISA)
Mr Jangley Bahia Costa
Brazilian Health Regulatory Agency (ANVISA)

Janet Hendry
Health Canada
Martina Buljan
Health Canada

Matthias Neumann
German Federal Ministry of Health
Nada Alkhayat
European Commission
Rolf Oberlin Hansen
Danish Medicines Agency
Valerie Soumet
National Agency for the Safety of Medicines and Health Products (ANSM)

Camille Vidal
GE Healthcare
Hyun-Bae Park
Kakao Healthcare
Koen Cobbaert
Philips Healthcare
Tomohisa Fukunaga
Canon Medical Systems

Cassie Scherer
Industry Representatives (GMTA)
Diane Johnson
Johnson & Johnson Medical
Kees Maquelin
Industry Representatives (GMTA)
Mr Toshiaki Nakazato
Canon Medical Systems

Dr Kentaro Kato
Pharmaceuticals and Medical Devices Agency (PMDA)
Dr Madoka Murakami
Ministry of Health, Labour and Welfare (MHLW)
Mr Kuniki Imagawa
Pharmaceuticals and Medical Devices Agency (PMDA)
Yuhei Fukuta
Ministry of Health, Labour and Welfare (MHLW)

Mr Ong Ming Hao
Health Sciences Authority (HSA)
Ms Siew Jie Yee
Health Sciences Authority (HSA)

Byung-Gwan Kim
Ministry of Food and Drug Safety (MFDS)
Rosa Da-yeong Ryoo (Ms)
Ministry of Food and Drug Safety (MFDS)

Guido Strack
Swissmedic
Rudolf Waelti
Swissmedic

David Grainger
Medicines and Healthcare products Regulatory Agency (MHRA)
Russell Pearson
Medicines and Healthcare products Regulatory Agency (MHRA)

Catherine Bahr
Food and Drug Administration (US FDA)
Wil Vargas
Food and Drug Administration (US FDA)

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

The World Health Organization (WHO)

Saudi Arabia, Saudi Food and Drug Authority

Switzerland, Swissmedic

Affiliate members

Botswana - Botswana Medicines Regulatory Authority (BoMRA)

Chile - Public Health Institute of Chile (ISP)

Chinese Taipei Taiwan Food and Drug Administration (TFDA)

Costa Rica - Ministry of Health

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)

India - Central Drugs Standard Control Organization (CDSCO)

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)

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)

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

Tanzania - Tanzania Medicines and Medical Devices Authority (TMDA)

Zimbabwe - Medicines Control Authority (MCAZ)