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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

Current Work Item

The purpose of the current Work Item is to develop a common set of competency, training, and conduct requirements for regulatory reviewers that perform premarket reviews/assessments of the technical documentation of a submission/design dossier and is intended to develop confidence in the consistency of regulatory reviews across jurisdictions.

Australia

  • Dr. Elizabeth McGrath
    Therapeutic Goods Administration

Brazil

  • Valter Pereira de Oliveira
    Brazilian Health Surveillance Agency (ANVISA)
  • Thiberio Mundim Ferreira Pires
    Brazilian Health Surveillance Agency (ANVISA)
  • Camila Gonçalves Moreira
    Brazilian Health Surveillance Agency (ANVISA)

Canada

  • Caroline Vanneste
    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

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

  • Amiran Preobrazhenskiy
    Roszdravnadzor
  • Vladimir Antonov
    Roszdravnadzor

United States of America

  • Erin Keith
    US Food and Drug Administration
  • Melissa Torres
    US Food and Drug Administration

World Health Organization

  • Helena Ardura-Garcia
    World Health Organization (WHO)
  • Robyn Meurant
    World Health Organization (WHO)