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Management Committee members and alternates

IMDRF Management Committee

Chair (2019)

Australia

  • Tracey Duffy
    First Assistant Secretary
    Medical Devices and Product Quality Division
    Therapeutic Goods Administration
    Email: Tracey.Duffy@health.gov.au
  • Dr Elizabeth McGrath
    Director, Devices Conformity Assessment
    Medical Devices Branch
    Medical Devices and Product Quality Division
    Therapeutic Goods Administration
    Email: Elizabeth.McGrath@health.gov.au

Brazil

  • Leandro Rodrigues Pereira
    General Manager, Office of Medical Devices
    Brazilian Health Regulatory Agency (ANVISA)
    Email: Leandro.Pereira@anvisa.gov.br
  • Ms Patricia Pereira Tagliari
    Advisor, General Office of Inspection - GGFIS
    Brazilian Health Regulatory Agency (ANVISA)
    Email: patricia.pereira@anvisa.gov.br

Canada

  • David Boudreau
    Director
    Medical Devices Bureau
    Therapeutic Products Directorate
    Health Products and Food Branch
    Health Canada
    Email: david.boudreau@canada.ca
  • Nancy Shadeed
    Manager, International Programs Division
    Bureau of Policy, Science and International Programs
    Therapeutic Products Directorate
    Health Products and Food Branch
    Health Canada
    Email: nancy.shadeed@canada.ca

China

  • Wang Shucai
    Deputy director general
    China National Medical Products Administration (NMPA)
    Email: wangsc@nmpa.gov.cn
  • Li Yijie
    Principal Staff Member
    China National Medical Products Administration (NMPA)
    Email: liyj@nmpa.gov.cn

European Union

  • Erik Hansson
    Deputy Head of Unit
    European Commission
    Directorate General for Internal Market, Industry, Entrepreneurship and SMEs
    Health Technology and Cosmetics
    Email: Erik.Hansson@ec.europa.eu
  • Jean-Claude Ghislain
    Scientific adviser
    Directorate-general
    Agence nationale de sécurité du médicament et des produits de santé (ANSM)
    AFSSAPS
    Email: Jean-claude.ghislain@ansm.sante.fr
  • Niall MacAleenan
    Head of Medical Device Department
    Health Products Regulatory Authority (HPRA)
    Email: niall.macaleenan@hpra.ie
  • Matthias Neumann
    Deputy Head
    Medical Devices Safety Unit
    German Federal Ministry of Health
    Email: matthias.neumann@bmg.bund.de

Japan

  • Mari Shirotani
    Division Director
    Division of Regulatory Cooperation
    Office of International Programs
    Pharmaceuticals and Medical Devices Agency (PMDA)
    Email: shirotani-mari@pmda.go.jp
  • Yumiko Aoyagi
    Deputy Director
    Office of International Regulatory Affairs/
    Medical Device Evaluation Division
    Pharmaceutical Safety and Environmental Health Bureau
    Ministry of Health, Labour and Welfare (MHLW)
    Email: aoyagi-yumiko@mhlw.go.jp

Russia

South Korea

  • Jinyoung Yang
    Director General
    Medical Device Safety Bureau
    Ministry of Food and Drug Safety (MFDS)
    policymfds@korea.kr
  • Hyeon-joo Oh
    Director General
    Medical Device Evaluation Department
    National Institute of Food and Drug Safety Evaluation (NIFDS)
    Ministry of Food and Drug Safety (MFDS)
    hyeonjoo@korea.kr

Singapore

United States of America

  • Jeffrey Shuren
    Director
    Center for Devices and Radiological Health
    US FDA
    Email: jeff.shuren@fda.hhs.gov
  • Melissa Torres
    Associate Director
    International Affairs
    Office of the Center Director
    Center for Devices and Radiological Health
    US FDA
    Email: melissa.torres@fda.hhs.gov

IMDRF Official Observers

World Health Organization (WHO)

  • Irena Prat
    Group lead
    Diagnostics Assessment
    World Health Organization (WHO)
    Email: prati@who.int

Regional Harmonization Initiative Representatives

APEC LSIF Regulatory Harmonization Steering Committee

  • Shu-Fen Wang
    Deputy Director
    Division of Medical Devices and Cosmetics
    Taiwan Food and Drug Administration
    Email: aa6056@fda.gov.tw
  • Cheng-Ning Wu
    Section Chief
    Division of Medical Devices and Cosmetics
    Taiwan Food and Drug Administration
    Email: emilywu@fda.gov.tw

Asian Harmonization Working Party (AHWP)

  • Ali M. AL-DALAAN
    AHWP TC-Chair
    Vice Executive President
    Medical Devices Sector
    Saudi Food and Drug Authority
    Email: AMDalaan@sfda.gov.sa

Pan American Health Organization (PAHO)

  • Analía Porrás
    Chief
    Health Technologies Unit
    Medicines and Health Technologies Department
    Health Systems and Services
    Email: porrasan@paho.org
  • Alexandre Lemgruber
    Regional Advisor
    Health Technologies Unit
    Medicines and Health Technologies Department
    Health Systems and Services
    Email: lemgruba@paho.org
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