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Artificial Intelligence Medical Devices (AIMD)

The purpose of this Work Item is to achieve a harmonized approach to the management of artificial intelligence (AI) medical devices. This work item will cover machine learning-based medical devices representing AI technology applied to medical devices and further standardize terminology for machine learning-based medical devices among member jurisdictions.

Working Group Chair: Dr Young-kyu Kang, MFDS, South Korea

Working Group Membership: Regulators and stakeholder membership

Australia

  • Dr David Hau
    Therapeutic Goods Administration (TGA)
  • Mr David Wotton
    Therapeutic Goods Administration (TGA)
  • Mrs Olivia Reeves
    Therapeutic Goods Administration (TGA)

Brazil

  • Mr Helio Bomfim de Macedo Filho
    Brazilian Health Surveillance Agency (ANVISA)
  • Mr Francisco Iran Cartaxo Barbosa
    Brazilian Health Surveillance Agency (ANVISA)
  • Mr Jangley Bahia Costa
    Brazilian Health Surveillance Agency (ANVISA)

Canada

  • Daniel Yoon
    Health Canada
  • Janet Hendry
    Health Canada

China

  • Mr. Zhang Song
    Center for Medical Device Evaluation (CMDE), NMPA
  • Mr. Liu Xiaoyin
    Center for Medical Device Evaluation (CMDE), NMPA
  • Mr. Wang Zehua
    Center for Medical Device Evaluation (CMDE), NMPA
  • Mr. Wang Hao
    National Institute for Food and Drug Control (NIFDC), NMPA
  • Mr. Wang Chenxi
    National Institute for Food and Drug Control (NIFDC), NMPA

European Union

  • Steffen Buchholz
    BMG-Federal Ministry of Health
  • Mariana Madureira
    INFARMED - National Authority of Medicines and Health Products, I.P.
  • Alexander Norup Nielsen
    Danish Medicines Agency
  • Nada Alkhayat
    European Commission

Japan

  • Mr Yuhei Fukuta
    Ministry of Health, Labour and Welfare (MHLW)
  • Ms Yoko Tateno
    Ministry of Health, Labour and Welfare (MHLW)
  • Ms Kanako Sasaki
    Ministry of Health, Labour and Welfare (MHLW)
  • Mr Watanabe Yoshitomo
    Pharmaceuticals and Medical Devices Agency (PMDA)
  • Mr Sato Yuchi
    Pharmaceuticals and Medical Devices Agency (PMDA)
  • Mr Kuniki Imagawa
    Pharmaceuticals and Medical Devices Agency (PMDA)

Russia

  • Vladimir Kutichev
    Roszdravnadzor

Singapore

  • Dr Yow Soh Zeom
    Health Sciences Authority (HSA)
  • Mr Lin Anle
    Health Sciences Authority (HSA)

South Korea

  • Dr Young-Kyu Kang
    Ministry of Food & Drug Safety (MFDS)
  • Mr Seung-Ho Son
    Ministry of Food & Drug Safety (MFDS)
  • Mr Hyun-Soo Kim
    Ministry of Food & Drug Safety (MFDS)
  • Mr Byeong-Nam Kim
    Ministry of Food & Drug Safety (MFDS)
  • Mr Dong-Jun Kim
    Ministry of Food & Drug Safety (MFDS)
  • Ms Ki-Na Kim
    Ministry of Food & Drug Safety (MFDS)
  • Dr Se-il Park
    Ministry of Food & Drug Safety (MFDS)

United States of America

  • Bakul Patel
    U.S. Food and Drug Administration (FDA)
  • Matthew Diamond
    U.S. Food and Drug Administration (FDA)

World Health Organization

  • Dr Philippe Boeuf
    Inspection Services, Prequalification Unit (PQT), WHO
  • Anita Sands
    Incidents and Substandard/Falsified Medical Products (ISF) team, WHO

Industry Representative (GMTA)

  • Pat Baird
    Philips Healthcare
  • Mr Toshiaki Nakazato
    Canon Medical Systems cooperation
  • Patricia A. Krantz-Zuppan
    Medtronic
  • Mr Hyun-Bae Park
    VUNO Inc.

Industry Representatives (DITTA)

  • Koen Cobbaert
    Philips Healthcare, Europe
  • Naoki Morooka
    Shimadzu Corporation, Japan
  • Camille Vidal
    GE Healthcare, USA
  • Annika Eberstein
    COCIR, Europe