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Software as a Medical Device (SaMD)

This work item is now complete. This page has been retained for historical reference.

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.

To date, the SaMD WG has published the following documents:

Current work item:

The group is currently developing guidance for the Clinical Evaluation and Evidence for Software as a Medical Device (SaMD). The group's objective is to provide detailed guidance and clarify on when and to what level clinical evaluation and evidence is necessary or acceptable for SaMD from a patient safety perspective with particular emphasis for those types of SaMD with diagnostic functionality.

Working Group Chair: Bakul Patel, US Food and Drug Administration - contact Bakul Patel

Working Group Membership: Regulator and stakeholder membership


  • Dr. David Hau
    Therapeutic Goods Administration


  • Alessandro Ferreira do Nascimento
    Brazilian Health Surveillance Agency (ANVISA)


  • Nancy Shadeed
    Health Canada


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

European Union

  • Mats Artursson
    Medical Products Agency; Sweden
  • Salvatore Scalzo
    European Commission
  • Thierry Sirdey
    Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM); France


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


  • Dr. Rama Sethuraman
    Health Sciences Authority (HSA)

United States of America

  • Bakul Patel
    US Food and Drug Administration
  • Dr. Doug Silverstein
    US Food and Drug Administration

Industry, Research and Academia

  • Christian Bohrt
    GMTA; Germany
  • Dr. Joe Cafazzo
    University of Toronto; Canada
  • Dr. Murali Doraiswamy
    Duke University; USA
  • Dr. Tibor Duliskovich
  • Regis Guillemaud
    Commissariat à l’énergie atomique et aux énergies alternatives (CEA); France
  • Keiichiro Ozawa
    DITTA; Japan
  • Dr. Leslie Saxon
    University of Southern California; USA
  • Tamara (Tami) Shipman