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Regulated Product Submission

The charter of this Work Item is to take advantage of a project underway internationally that will result in a messaging standard that supports the electronic transmission of regulatory submissions. This work will define a common ‘Table of Contents’ for medical device regulatory submissions as a first step in defining a common data set.

Working Group Chair: Nancy Shadeed contact Nancy Shadeed

Working Group Membership: Regulator only and regulator and stakeholder membership

Australia

  • Elizabeth McGrath
    Therapeutic Goods Administration
  • John Bell
    Group Support Unit
    Market Authorisation Group
    Therapeutic Goods Administration

Brazil

  • Vivian Cardoso de Morais
    General Office of Medical Devices Technology
    Agência Nacional de Vigilância Sanitária (ANVISA)
  • Augusto Bencke Geyer
    Office of In-vitro Diagnostics
    Agência Nacional de Vigilância Sanitária (ANVISA)

Canada

  • Nancy Shadeed (Chair)
    Manager
    Health Canada
    nancy.shadeed@hc-sc.gc.ca
  • Brian Dowling (ToC Lead)
    Senior Scientific Evaluator
    Musculoskeletal Devices
    Medical Devices Bureau
    Health Canada
  • Vikesh Srivastava
    Associate Director
    Business Informatics Division
    Resource Management and Operations Directorate
    Health Canada
  • Daniel Yoon
    Regulatory Advisor
    International Programs Division
    Bureau of Policy, Science and International Programs
    Health Canada

China

  • Shiqing Zhang
    Centre for Medical Device Evaluation
    China Food and Drug Administration (CFDA)
  • Yue Min
    Centre for Medical Device Evaluation
    China Food and Drug Administration (CFDA)

European Union

  • Salvatore Scalzo (European Commission)
  • Maria Carleton
    Health Products Regulatory Authority (HPRA-Ireland)

Japan

  • Yuzuru Okazaki
    Deputy Review Director
    Office of Medical Device I
    Pharmaceuticals and Medical Devices Agency (PMDA)
  • Yoshimasa Yokoyama
    Office of Medical Device I
    Pharmaceuticals and Medical Devices Agency (PMDA)
  • Tomoaki Hasegawa
    Office of Medical Device I
    Pharmaceuticals and Medical Devices Agency (PMDA)

United States

  • Patrick Axtell
    USFDA
  • Jodi Anderson (ToC Rep)
    USFDA

ABIMO

  • Leo Albornoz
    ABIMO

Global Diagnostic Imaging, Healthcare IT & Radiation Therapy Trade Association (DITTA)

  • Naoki Morooka
    Manager
    Regulatory and Quality Control Group
    Quality Assurance Department Medical Systems of Shimadzu Corporation
  • Stefan Feix
    GE Canada

Global Medical Technology Alliance (GMTA)

  • Linda Tremblay
    Johnson & Johnson Medical Co.
  • Jackie Elkin
    Medtronic Inc.
  • Michelle Klein
    Stryker

Notified Bodies

  • Jurgen Kunte
    TUV - SUD

WHO

  • Helena Ardura-Garcia
    Prequalification of Diagnostics Dossier Assessment Team
    World Health Organisation
  • Robyn Meurant
    Essential Medicines and Health Products
    World Health Organization