Management Committee members & alternates

IMDRF Management Committee

Chair - Australia (2022)

• Tracey Duffy
  First Assistant Secretary
  Medical Devices and Product Quality Division
  Therapeutic Goods Administration

       Contact the IMDRF Secretariat via email: imdrf2022 [at] tga.gov.au

Australia

• John Jamieson
  Assistant Secretary
  Medical Devices Authorisation Branch
  Medical Devices and Product Quality Division
  Therapeutic Goods Administration
  Email: John.Jamieson [at] health.gov.au
• Meryl Clarke
  Director - Medical Devices Strategic Policy
  Medical Devices and Product Quality Division
  Therapeutic Goods Administration
  Email: meryl.clarke [at] health.gov.au

Brazil

• Leandro Rodrigues Pereira
  General Manager, Office of Medical Devices
  Brazilian Health Regulatory Agency (ANVISA)
  Email: Leandro.Pereira [at] anvisa.gov.br
• Ana Carolina Marino
  Head, Inspection Office
  Brazilian Health Regulatory Agency (ANVISA)
  Email: Ana.Marino [at] anvisa.gov.br

Canada

• David Boudreau
  Director General
  Medical Devices Directorate
  Health Products and Food Branch
  Health Canada
  Email: david.boudreau [at] hc-sc.gc.ca

China

• Mr. Li Gang
  Department of Science, Technology and International Cooperation
  China National Medical Products Administration (NMPA)
  Email: ligang [at] nmpa.gov.cn

European Union

• Erik Hansson
  Former Deputy Head of Unit
  European Commission
  Email: Hanssonerik [at] yahoo.com
• Nada Alkhayat
  Policy Officer
  Medical Devices and Health Technology
  Directorate-General for Health and Food Safety 
  European Commission
  Email: nada.alkhayat [at] ec.europa.eu
• Chloe Spathari
  Policy Officer
  Medical Devices and Health Technology
  Directorate-General for Health and Food Safety 
  European Commission
  Email: chloe.spathari [at] ec.europa.eu
• Niall MacAleenan
  Head of Medical Device Department
  Health Products Regulatory Authority (HPRA), Ireland
  Email: niall.macaleenan [at] hpra.ie
• Matthias Neumann
  Deputy Head
  Medical Devices Safety Unit
  German Federal Ministry of Health
  Email: matthias.neumann [at] bmg.bund.de

Japan

• Tetsuya Kusakabe
  International Coordination Officer
  Pharmaceuticals and Medical Devices Agency (PMDA)
  Email: kusakabe-tetsuya [at] pmda.go.jp
• Hirooki Tanabe
  Deputy Director
  Medical Device Evaluation Division
  Ministry of Health, Labour and Welfare (MHLW)
  Email: tanabe-hirooki [at] mhlw.go.jp

Russia

• Elena Astapenko
  Director
  Department of Drug Supply and Regulation of the Circulation of Medical Devices
  Ministry of Health
  Email: AstapenkoEM [at] minzdrav.gov.ru
• Vladimir Antonov
  CEO Adviser
  NQI RUSSIA
  Roszdravnadzor
  Email: vs-antonov [at] mail.ru

Singapore

• Woei Jiuang Wong
  Assistant Group Director
  Medical Devices Cluster
  Health Products Regulation Group
  Health Sciences Authority (HSA)
  Email: wong_woei_jiuang [at] hsa.gov.sg
• Rama Sethuraman
  Director
  Medical Devices Branch
  Health Products Regulation Group
  Health Sciences Authority (HSA)
  Email: Sethuraman_rama [at] hsa.gov.sg

South Korea

• Nam-Hee Lee
  Director General
  Medical Device Safety Bureau
  Ministry of Food and Drug Safety (MFDS)
  Email: policymfds [at] korea.kr
• Jeong-Rim Lee
  Director General
  Medical Device Evaluation Department
  National Institute of Food and Drug Safety Evaluation (NIFDS)
  Ministry of Food and Drug Safety (MFDS)
  Email: leejr84 [at] korea.kr

UK, Medicines and Healthcare products Regulatory Agency

• Dr Laura Squire
  Chief Healthcare Quality & Access Officer
  Medicines and Healthcare products Regulatory Agency (MHRA)
  Email: laura.squire [at] mhra.gov.uk
• Penny Wilson
  Medicines and Healthcare products Regulatory Agency (MHRA)
  Email: penny.wilson [at] mhra.gov.uk

United States of America

• Jeffrey Shuren
  Director
  Center for Devices and Radiological Health
  US FDA
  Email: Jeff.Shuren [at] 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 [at] fda.hhs.gov

IMDRF Official Observers

Argentina, National Administration of Drugs, Food and Medical Devices

• Dr. Marcela Rizzo
  Director of the National Institute of Medical Devices (INPM)
  National Administration of Drugs, Food and Medical Devices (ANMAT)
  Email: marcela.rizzo [at] anmat.gob.ar
• Mg. Sebastian Duarte
  Director of the Office of the Institutional Relations
  National Administration of Drugs, Food and Medical Devices (ANMAT)
  Email: sebastian.duarte [at] anmat.gob.ar

World Health Organization (WHO)

• Ms Susie Braniff
  Acting Team Lead
  World Health Organisation (WHO)
  Email: braniffs [at] 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 [at] fda.gov.tw
• Cheng-Ning Wu
  Section Chief
  Division of Medical Devices and Cosmetics
  Taiwan Food and Drug Administration
  Email: emilywu [at] fda.gov.tw

Global Harmonization Working Party (GHWP)

• Ali M. AL-DALAAN
  AHWP Chair
  Vice Executive President
  Medical Devices Sector
  Saudi Food and Drug Authority
  Email: AMDalaan [at] 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 [at] paho.org
• Alexandre Lemgruber
  Regional Advisor
  Health Technologies Unit
  Medicines and Health Technologies Department
  Health Systems and Services
  Email: lemgruba [at] paho.org