Working Group Chair: Dr Young-kyu Kang, MFDS, South Korea

Working Group Membership: Regulators and stakeholder membership

China
Mr. Zhang Song
Center for Medical Device Evaluation (CMDE), NMPA

Mr. Liu Xiaoyin
Center for Medical Device Evaluation (CMDE), NMPA

Mr. Wang Zehua
Center for Medical Device Evaluation (CMDE), NMPA

Mr. Wang Hao
National Institute for Food and Drug Control (NIFDC), NMPA

Mr. Wang Chenxi
National Institute for Food and Drug Control (NIFDC), NMPA

Australia
Dr David Hau
Therapeutic Goods Administration (TGA)

Mr David Wotton
Therapeutic Goods Administration (TGA)

Mrs Olivia Reeves
Therapeutic Goods Administration (TGA)

Brazil
Mr Helio Bomfim de Macedo Filho
Brazilian Health Surveillance Agency (ANVISA)

Mr Francisco Iran Cartaxo Barbosa
Brazilian Health Surveillance Agency (ANVISA)

Mr Jangley Bahia Costa
Brazilian Health Surveillance Agency (ANVISA)

Canada
Daniel Yoon
Health Canada

Janet Hendry
Health Canada

European Union
Steffen Buchholz
BMG-Federal Ministry of Health

Mariana Madureira
INFARMED - National Authority of Medicines and Health Products, I.P.

Alexander Norup Nielsen
Danish Medicines Agency

Nada Alkhayat
European Commission

Japan
Mr Yuhei Fukuta
Ministry of Health, Labour and Welfare (MHLW)

Ms Yoko Tateno
Ministry of Health, Labour and Welfare (MHLW)

Ms Kanako Sasaki
Ministry of Health, Labour and Welfare (MHLW)

Mr Watanabe Yoshitomo
Pharmaceuticals and Medical Devices Agency (PMDA)

Mr Sato Yuchi
Pharmaceuticals and Medical Devices Agency (PMDA)

Mr Kuniki Imagawa
Pharmaceuticals and Medical Devices Agency (PMDA)

Russia
Vladimir Kutichev
Roszdravnadzor

Singapore
Dr Yow Soh Zeom
Health Sciences Authority (HSA)

Mr Lin Anle
Health Sciences Authority (HSA)

South Korea
Dr Young-Kyu Kang
Ministry of Food & Drug Safety (MFDS)

Mr Seung-Ho Son
Ministry of Food & Drug Safety (MFDS)

Mr Hyun-Soo Kim
Ministry of Food & Drug Safety (MFDS)

Mr Byeong-Nam Kim
Ministry of Food & Drug Safety (MFDS)

Mr Dong-Jun Kim
Ministry of Food & Drug Safety (MFDS)

Ms Ki-Na Kim
Ministry of Food & Drug Safety (MFDS)

Dr Se-il Park
Ministry of Food & Drug Safety (MFDS)

United States of America
Bakul Patel
U.S. Food and Drug Administration (FDA)

Matthew Diamond
U.S. Food and Drug Administration (FDA)

World Health Organization
Dr Philippe Boeuf
Inspection Services, Prequalification Unit (PQT), WHO

Anita Sands
Incidents and Substandard/Falsified Medical Products (ISF) team, WHO

Industry Representative (GMTA)
Pat Baird
Philips Healthcare

Mr Toshiaki Nakazato
Canon Medical Systems cooperation

Patricia A. Krantz-Zuppan
Medtronic

Mr Hyun-Bae Park
VUNO Inc.

Industry Representatives (DITTA)
Koen Cobbaert
Philips Healthcare, Europe

Naoki Morooka
Shimadzu Corporation, Japan

Camille Vidal
GE Healthcare, USA

Annika Eberstein
COCIR, Europe

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