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Good Regulatory Review Practices

The charter of the Working Group (WG) is to develop guidance that establishes good regulatory review practices for Regulatory Authorities and/or their Conformity Assessment Bodies. The goal is to promote global harmonization in the premarket review processes.

Working Group Chair: Melissa Torres, USA contact Melissa Torres

Working Group Membership: Regulator membership

The goal of the Good Regulatory Review Practices Working Group is to improve the effectiveness and efficiency of premarket review. The GRRP working group has produced documents to support premarket review including:

  • IMDRF/GRRP WG/N40FINAL:2017: Competence, Training, and Conduct Requirements and
  • IMDRF/GRRP WG/N47FINAL:2018: Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices.

Current work items include revising GHTF/SG1/N70:2011 Label and Instructions for Use and the development of recognition requirements for medical device premarket review organizations.

Australia

  • Dr Elizabeth McGrath
    Therapeutic Goods Administration
  • Fiona McCormack
    Therapeutic Goods Administration

Brazil

  • Camila Gonçalves Moreira
    Brazilian Health Surveillance Agency (ANVISA)
  • Leidy Teixeira
    Brazilian Health Surveillance Agency (ANVISA)

Canada

  • Maria Carballo
    Health Canada
  • Catherine Milley
    Health Canada

China

  • Yuxi Yang
    Center for Medical Device Evaluation (CMDE)
  • Shiqing Zhang
    Center for Medical Device Evaluation (CMDE)

European Union

  • Rob Higgins
    MHRA - UK
  • Sharon Knight
    MHRA - UK

Japan

  • Aoyagi Yumiko
  • Ministry of Health, Labour and Welfare (MHLW)
  • Dr. Koichi Aizawa
    Pharmaceuticals and Medical Devices Agency (PMDA)
  • Takehiro Ichikawa
    Pharmaceuticals and Medical Devices Agency (PMDA)
  • Dr. Madoka Murakami
    Pharmaceuticals and Medical Devices Agency (PMDA)

Russia

  • Vladimir Antonov
    Roszdravnadzor

South Korea

  • Soonyeong Park
    Ministry of Food and Drug Safety

Singapore

  • Lakshmidevi Balakrishnan
    Health Sciences Authority

United States of America

  • Dr Kenneth Cavanaugh
    US Food and Drug Administration
  • Melissa Torres
    US Food and Drug Administration

World Health Organization

  • Deirdre Healy
    World Health Organization (WHO)
  • Irena Prat
    World Health Organization (WHO)
  • Mark Lanigan
    World Health Organization (WHO)