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Management Committee members and alternates

IMDRF Management Committee

Chair (2018)

  • Yuan Lin PhD, MBA
    Director General
    Department of International Cooperation
    China Food and Drug Administration
    Email: yuanlin@cfda.gov.cn

Australia

  • Adriana Platona
    First Assistant Secretary
    Medical Devices and Product Quality Division
    Therapeutic Goods Administration
    Email: adriana.platona@tga.gov.au
  • Tracey Duffy
    Assistant Secretary
    Medical Devices Branch
    Medical Devices and Product Quality Division
    Therapeutic Goods Administration
    Email: tracey.duffy@health.gov.au

Brazil

  • Maria Angela da Paz
    Manager, Operation Permit Office
    Brazilian Health Regulatory Agency (ANVISA)
    Email: angela.paz@anvisa.gov.br
  • Leandro Rodrigues Pereira
    General Manager, Office of Medical Devices
    Brazilian Health Regulatory Agency (ANVISA)
    Email: Leandro.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 Lanming
    Director
    Department of Medical Device Registration Management
    Chinese Food and Drug Administration
    Email: wanglm@sfda.gov.cn
  • Qin Xiaoling
    Deputy Director
    Department of the International Cooperation
    Chinese Food and Drug Administration
    Email: qinxl@sfda.gov.cn

European Union

  • Erik Hansson
    Deputy Head of Unit
    Health Technology and Cosmetic Unit
    DG for Internal Market, Entrepreneurship and SMEs (GROW)
    European Commission
    Email: Erik.Hansson@ec.europa.eu
  • Jean-Claude Ghislain
    Director
    Direction de lꞋévaluation des dispositifs médicaux
    Départment des Vigilances
    AFSSAPS
    Email: Jean-claude.ghislain@afssaps.sante.fr
  • Niall MacAleenan
    Clinical Assessment and Policy Manager/Medical Device Lead
    Health Products Regulatory Authority
    Email: niall.macaleenan@hpra.ie
  • Matthias Neumann
    Senior Executive
    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 (Ms.)
    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

  • Mikhail Murashko
    Head of Roszdravnadzor
    Roszdravnadzor
    Email: prim@roszdravnadzor.ru
  • Vladimir Antonov
    Deputy General Director of Federal State Institution
    Center for Monitoring and Clinical and Economic Expertise
    Roszdravnadzor
    Email: belanov@roszdravnadzor.ru

South Korea

  • Chun-su Shin
    Director
    Medical Device Policy Division
    Medical Device Safety Bureau
    Ministry of Food and Drug Safety
    policymfds@korea.kr
  • Hyeon-joo Oh
    Director
    In Vitro Diagnostic Division, Medical Device Evaluation & Research Department
    National Institute of Food and Drug Safety Evaluation
    Ministry of Food and Drug Safety
    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)

Regional Harmonization Initiative Representatives

APEC LSIF Regulatory Harmonization Steering Committee

Asian Harmonization Working Party (AHWP)

Pan American Health Organization (PAHO)

  • Alexandre Lemgruber
    PAHO Regional Advisor
    Health Technologies
    Email: lemgruba@paho.org
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