Management Committee Members

IMDRF Management Committee

Chair - United States of America (2024)

• US Food and Drug Administration
  Contact the IMDRF Secretariat via email: IMDRF2024 [at] fda.hhs.gov (IMDRF2024[at]fda[dot]hhs[dot]gov)

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

• Karen de Aquino Noffs
  General Manager, Office of Medical Devices
  Brazilian Health Regulatory Agency (ANVISA)
  Email: karen.noffs [at] anvisa.gov.br (karen[dot]noffs[at]anvisa[dot]gov[dot]br)
• Thiago Rezende Pereira Cunha
  Manager, Medical Devices Inspection Office
  Brazilian Health Regulatory Agency (ANVISA)
  Email:Thiago.cunha [at] anvisa.gov.br (Thiago[dot]cunha[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)

European Union

• 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)

Japan

• Eriko Fukuda
  Pharmaceuticals and Medical Devices Agency (PMDA)
  Email: fukuda-eriko [at] pmda.go.jp;
• Yukina Ueno
  Pharmaceutical Safety and Environmental Health Bureau
  Ministry of Health, Labour and Welfare (MHLW)
  Email: ueno-yukina [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 (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)
• Lai Peng Low
  Deputy Director
  Therapeutic Devices Branch
  Medical Devices Cluster
  Health Products Regulation Group
  Health Sciences Authority (HSA)
  Email: low_lai_peng [at] hsa.gov.sg (low_lai_peng[at]hsa[dot]gov[dot]sg)

South Korea

• NamHee Lee 
  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)
• Hye-Won Roh
  Director General
  Medical Device Evaluation Department
  National Institute of Food and Drug Safety Evaluation (NIFDS)
  Ministry of Food and Drug Safety (MFDS)
  Email: beaustar [at] korea.kr (beaustar[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

• Melissa Torres
  Associate Director, International Affairs
  Center for Devices and Radiological Health (CDRH)
  US Food and Drug Administration
  Email: melissa.torres [at] fda.hhs.gov (melissa[dot]torres[at]fda[dot]hhs[dot]gov)
• Michelle Tarver
  Center Director
  Center for Devices and Radiological Health (CDRH)
  US Food and Drug Administration
  Email: michelle.tarver [at] fda.hhs.gov (michelle[dot]tarver[at]fda[dot]hhs[dot]gov)