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Principles of In Vitro Diagnostic (IVD) Medical Devices Classification

The objective of the Working Group is to review and update the GHTF / SG1 / N045:2008 Principles of In Vitro Diagnostic (IVD) Medical Devices Classification document, taking into account the current level of development and experience in applying the risk-based approach to the classification of IVD medical devices.

The goal is to promote global harmonization in the premarket review processes.

Working Group Chair: Tatyana Buryakina, Roszdravnadzor, Russia

Working Group Membership: Regulator and Regional Initiatives membership


  • Antje Janssen (Therapeutic Goods Administration (TGA))


  • Fabio Quintino (Brazilian Health Surveillance Agency (ANVISA))


  • Monica Magidin (Health Canada)


  • Ying Huang (National Institutes for Food and Drug Control)
  • Le Cui (National Institutes for Food and Drug Control)

European Union

  • Dr. Heiner Scheiblauer (Paul-Ehrlich-Institute, Federal Institute for Vaccines and Biomedicines, Germany)
  • Gaelle Lebrun (French Agency for the Safety of Health Products (ANSM), France)
  • Nada Alkhayat (European Commission, Belgium)


  • Hiromi Yamada (Pharmaceuticals and Medical Devices Agency (PMDA))
  • Eri Orihara (Pharmaceuticals and Medical Devices Agency (PMDA))
  • Mika Togashi (Pharmaceuticals and Medical Devices Agency (PMDA))
  • Yasuyuki Sakurai (Pharmaceuticals and Medical Devices Agency (PMDA))
  • Manabu Fukuzawa (Ministry of Health, Labour and Welfare (MHWL))
  • Fumihito Takanashi (Ministry of Health, Labour and Welfare (MHWL))


  • Vladimir Antonov (Roszdravnadzor)
  • Roman Bystrov (Roszdravnadzor)

Working Group Chair:

  • Tatyana Buryakina (Roszdravnadzor)

South Korea

  • Yong-kyoung LEE (Ministry of Food and Drug Safety (MFDS))
  • Young-wook AHN (Ministry of Food and Drug Safety (MFDS))


  • Rama Sethuraman (Health Sciences Authority (HSA))
  • Mr Danny Ong (Health Sciences Authority (HSA))

United States of America

  • Dina Jerebitski (US Food and Drug Administration (FDA))

World Health Organization

  • Irena Prat (World Health Organization (WHO))

Asian Harmonization Working Party (AHWP)

  • Wen-Wei Tsai (AHWP)
  • Yung-Chuan Lee (AHWP)
  • Mariamma Krishnasamy (AHWP)
  • Razan Asally (AHWP)

Pan American Health Organization (PAHO)

  • Mariela Aranda (ANMAT, Argentina)
  • Noaris Marquez (CECMED, Cuba)
  • Marcia Rodriguez (Ministry of Health, Uruguay)

Industry Representatives (GMTA)

  • Danelle Miller, J.D. (Global Regulatory Policy and Intelligence, Roche Diagnostics)
  • Masaki Sakakibara (Regulatory Affairs Division, SYSMEX Corporation)
  • Petra Kaars-Wiele (Independent Consultant, Germany)