Principles of In Vitro Diagnostic (IVD) Medical Devices Classification

Working Group Chair(s)
Tatyana Buryakina
Federal Service for Surveillance in Healthcare (Roszdravnadzor)
Russia
Membership
Regulator and Regional Initiatives membership
Status
Work completed

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.

Participants

Mariamma Krishnasamy
Asian Harmonization Working Party (AHWP)
Razan Asally
Asian Harmonization Working Party (AHWP)
Wen-Wei Tsai
Asian Harmonization Working Party (AHWP)
Yung-Chuan Lee
Asian Harmonization Working Party (AHWP)

Antje Janssen
Therapeutic Goods Administration (TGA)

Fabio Pereira Quintino
Brazilian Health Regulatory Agency (ANVISA)

Monica Magidin
Health Canada

Le Cui
National Institute for Food and Drug Control (NIFDC), NMPA
Ying Huang
National Institute for Food and Drug Control (NIFDC), NMPA

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

Danelle Miller
Global Regulatory Policy and Intelligence, Roche Diagnostics
Masaki Sakakibara
Sysmex Corporation
Petra Kaars-Wiele
Independent Consultant, Germany

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

Marcia Rodriguez
Ministry of Health, Uruguay
Mariela Aranda
National Administration of Drugs, Food and Medical Devices (ANMAT)
Noaris Marquez
Regulatory Authority of Medicines, Equipment and Medical Devices of the Republic of Cuba (CECMED)

Roman Bystrov
Federal Service for Surveillance in Healthcare (Roszdravnadzor)
Tatyana Buryakina
Federal Service for Surveillance in Healthcare (Roszdravnadzor)
Vladimir Antonov
Federal Service for Surveillance in Healthcare (Roszdravnadzor)

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

Yong-kyoung Lee
Ministry of Food and Drug Safety (MFDS)
Young-wook Ahn
Ministry of Food and Drug Safety (MFDS)

Dina Jerebitski
Food and Drug Administration (FDA)

Irena Prat
World Health Organization (WHO)