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
来源:医疗器械创新网