Software as a Medical Device (SaMD)

Working Group Chair(s)
Bakul Patel
Food and Drug Administration (FDA)
United States of America
Regulator and stakeholder membership
Work completed

The charter of the Working Group (WG) is to develop guidance that supports innovation and timely access to safe and effective Software as a Medical Device (SaMD) globally. The work is intended to identify commonalities, establish a common vocabulary and develop approaches for appropriate regulatory controls that promote prospective convergence in areas of advanced and innovative technologies in this topic area.

Note that this Working Group closed after the publication of N43 in 2017. In 2022, a new SaMD Working Group was established to provide further advice into this area. The new group's work items can be viewed here.

Technical/Informational document


Dr David Hau
Therapeutic Goods Administration (TGA)

Alessandro Ferreira do Nascimento
Brazilian Health Regulatory Agency (ANVISA)

Nancy Shadeed
Health Canada

Mr Peng Liang
Center for Medical Device Evaluation (CMDE), NMPA
Yuan Peng
China Food and Drug Administration (SFDA)

Mats Artursson
Medical Products Agency; Sweden
Salvatore Scalzo
European Commission
Thierry Sirdey
National Agency for the Safety of Medicines and Health Products (ANSM)

Keiichiro Ozawa
FUJIFILM Corporation

Christian Bohrt
GMTA; Germany
Joe Cafazzo
University of Toronto
Leslie Saxon
University of Southern California
Murali Doraiswamy
Duke University
Regis Guillemaud
Commissariat à l’énergie atomique et aux énergies alternatives (CEA)
Tamara (Tami) Shipman
Tibor Duliskovich
Global Diagnostic Imaging, Healthcare ICT, and Radiation Therapy Trade Association (DITTA)

Aya Komori
Pharmaceuticals and Medical Devices Agency (PMDA)
Dr Kentaro Kato
Pharmaceuticals and Medical Devices Agency (PMDA)
Yumiko Aoyagi
Ministry of Health, Labour and Welfare (MHLW)

Rama Sethuraman
Health Sciences Authority (HSA)

Bakul Patel
Food and Drug Administration (FDA)
Doug Silverstein
Food and Drug Administration (FDA)