Management Committee members & alternates

IMDRF Management Committee

Chair - European Union (2023)

• Andrzej Rys
  Principal Scientific Adviser
  Directorate-General for Health and Food Safety (DG SANTE)
  European Commission

       Contact the IMDRF Secretariat via email: IMDRF2023 [at] ec.europa.eu (IMDRF2023[at]ec[dot]europa[dot]eu)

European Union

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

Australia

• Tracey Duffy
  First Assistant Secretary
  Medical Devices and Product Quality Division
  Therapeutic Goods Administration
  Email: tracey.duffy [at] health.gov.au (tracey[dot]duffy[at]health[dot]gov[dot]au)
• John Jamieson
  Assistant Secretary
  Medical Devices Authorisation Branch
  Medical Devices and Product Quality Division
  Therapeutic Goods Administration
  Email: John.Jamieson [at] health.gov.au (John[dot]Jamieson[at]health[dot]gov[dot]au)

Brazil

• Augusto Bencke Geyer
  General Manager, Office of Medical Devices
  Brazilian Health Regulatory Agency (ANVISA)
  Email: augusto.geyer [at] anvisa.gov.br (augusto[dot]geyer[at]anvisa[dot]gov[dot]br)
• Ana Carolina Marino
  Head, Inspection Office
  Brazilian Health Regulatory Agency (ANVISA)
  Email:Ana.Marino [at] anvisa.gov.br (Ana[dot]Marino[at]anvisa[dot]gov[dot]br)

Canada

• Bruce Randall
  Acting Director General
  Medical Devices Directorate
  Health Products and Food Branch
  Health Canada
  Email: bruce.randall [at] hc-sc.gc.ca (bruce[dot]randall[at]hc-sc[dot]gc[dot]ca)
• Sally Prawdzik

  Acting Director
  Bureau of Policy and International Programs
  Medical Devices Directorate
  Health Products and Food Branch
  Health Canada
  Email: sally.prawdzik [at] hc-sc.gc.ca (sally[dot]prawdzik[at]hc-sc[dot]gc[dot]ca)

China

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

Japan

• Tetsuya Kusakabe
  International Coordination Officer
  Pharmaceuticals and Medical Devices Agency (PMDA)
  Email: kusakabe-tetsuya [at] pmda.go.jp (kusakabe-tetsuya[at]pmda[dot]go[dot]jp)
• Tomoyuki Miyasaka 
  Deputy Director (International)
  Medical Devices Evaluation Division
  Pharmaceutical Safety and Environmental Health Bureau
  Ministry of Health, Labour and Welfare (MHLW)
  Email: miyasaka-tomoyuki [at] mhlw.go.jp (miyasaka-tomoyuki[at]mhlw[dot]go[dot]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 (AstapenkoEM[at]minzdrav[dot]gov[dot]ru)
• Vladimir Antonov
  CEO Adviser
  NQI RUSSIA
  Roszdravnadzor
  Email: vs-antonov [at] mail.ru (vs-antonov[at]mail[dot]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 (wong_woei_jiuang[at]hsa[dot]gov[dot]sg)
• Rama Sethuraman
  Director
  Medical Devices Branch
  Health Products Regulation Group
  Health Sciences Authority (HSA)
  Email: Sethuraman_rama [at] hsa.gov.sg (Sethuraman_rama[at]hsa[dot]gov[dot]sg)

South Korea

• Gyuhan Chae 
  Director General
  Medical Device Safety Bureau
  Ministry of Food and Drug Safety (MFDS)
  Email: maria12 [at] korea.kr (p)policymfds [at] korea.kr (olicymfds[at]korea[dot]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 (leejr84[at]korea[dot]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 (laura[dot]squire[at]mhra[dot]gov[dot]uk)
• Dr Harriet Teare
  Deputy Director of Partnerships
  Medicines and Healthcare products Regulatory Agency (MHRA)
  Email: harriet.teare [at] mhra.gov.uk (harriet[dot]teare[at]mhra[dot]gov[dot]uk)

United States of America

• Jeffrey Shuren
  Director
  Center for Devices and Radiological Health
  US FDA
  Email: Jeff.Shuren [at] fda.hhs.gov (jeff[dot]shuren[at]fda[dot]hhs[dot]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 (melissa[dot]torres[at]fda[dot]hhs[dot]gov)