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Medical Device Clinical Evaluation

Working Group Chair: Dr Yinghui Liu, China contact Dr Yinghui Liu

Working Group Membership: Regulatory and stakeholder membership

Current Work Item

The purpose of the current Work Item is to improve the effectiveness and efficiency of premarket review by promoting increased global harmonization in approach and requirements on leveraging and evaluating the available clinical evidence, reduce the number of redundant clinical trials, integrate the principles of post-market clinical follow up and real world evidence, as applicable, and accelerate the introduction of new safe and effective medical devices/ technologies to the patients in variable jurisdictions.

The working group is developing IMDRF Technical Documents by updating the current GHTF documents on clinical evaluation which include GHTF SG5 N1, N2 and N3 documents.

Australia

  • Dr Simon Singer
    Therapeutic Goods Administration (TGA)

Brazil

  • Alessandro Ferreira do Nascimento
    Brazilian Health Surveillance Agency (ANVISA)
  • Leticia Barel Filier
    Brazilian Health Surveillance Agency (ANVISA)

Canada

  • Amanda Jones
    Medical Devices Bureau, Health Canada

China

  • Dr Yinghui Liu
    Center for Medical Device Evaluation (CMDE)
  • Shan Ju
    Center for Medical Device Evaluation (CMDE)
  • Dr Yawen Wang
    Center for Medical Device Evaluation (CMDE)

European Union

  • Camilla Fleetcroft
    MHRA - UK
  • • Gwennaelle Even
    ANSM - France

Japan

  • Aoyagi Yumiko
  • Ministry of Health, Labour and Welfare (MHLW)
  • Dr Daisuke Tanaka
    Ministry of Health, Labour and Welfare (MHLW)
  • Dr Mami Ho
    Pharmaceuticals and Medical Devices Agency (PMDA)
  • Dr Daisuke Fujisawa
    Pharmaceuticals and Medical Devices Agency (PMDA)

Russia

  • Valeeva Aisylu
    Roszdravnadzor
  • Kurtukov Yaroslav
    Roszdravnadzor

Singapore

  • Low Lai Peng
    Health Sciences Authority (HSA)

South Korea

  • Youngsook Choi
    Ministry of Food and Drug Safety(MFDS)
  • Youngmin Han
    Ministry of Food and Drug Safety(MFDS)

United States of America

  • Dr Soma Kalb
    US Food and Drug Administration
  • Dr Minerva Hughes
    US Food and Drug Administration

Pan American Health Organization

  • Dr. Micaela Dominguez
    Pan American Health Organization (PAHO)

Global Diagnostic Imaging, Healthcare IT & Radiation Therapy Trade Association (DITTA)

  • Keiichiro Ozawa
    FUJIFILM Corporation
  • Leo Hovestadt
    Elekta
  • Bradley Matsubara
    Philips

Global Medical Technology Alliance (GMTA)

  • Michael Pfleger
    Alcon
  • Robin Newman
    Johnson & Johnson Medical
  • Dr Theodore Lystig
    Medtronic