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Work Group 5 (WG5) - Clinical Evidence for Performance and Safety

Chair: Ms. Yuwadee PATANAWONG
Director
Medical Devices Control Division
Food and Drug Administration, Ministry of Public Health
Thailand
Regulatory Authority
Co-Chair: Ms. Sumati Randeo
Director Global Strategy
Regulatory Affairs & Advocacy
Abbott Quality and Regulatory
Abbott Laboratories
India
Industry

Secretary:

Mr. Gaurav Verma
Principal Consultant
Asia Actual India (OPC) Private Limited
India

Industry
Advisor: Ms Shelley Tang
Principal
Stellar consulting
Australia
Industry
Advisor: Dr. Martin A. Devitt
Managing Director
Lifecycle Medical
Australia
Industry
Member: Mr. Abdullah Salem AL-DOBAIB
Executive Director of Registration and Licensing Department
Medical Device Sector
Saudi Food & Drug Authority
Kingdom of Saudi Arabia
Regulatory Authority
Member: Ms. Thangavelu SASIKALA
MD Bureau
Ministry of Health
Malaysia
Regulatory Authority
Member: Dr. KRISHNASAMY Mariammah
Senior Assistant Director
Medical Device Control Division
Ministry of Health Malaysia
Malaysia
Regulatory Authority
Member:

Mr Ji Hun CHA
Assistant Director
Ministry of Food and Drug Safety
Department of Medical Device Evaluation
Cardiovascular Devices Division
Republic of Korea

Regulatory Authority
Member:  Mr Kwon Ho Beom
Associate Professor
Seoul National University
Republic of Korea
Regulatory Authority
Member: Mr. SIU Hiu Fai Stanley
Engineer
Electrical and Mechanical Services Department
Government of the Hong Kong Special Administrative Region
Hong Kong SAR, China
Regulatory Authority
Member: Dr. Chi Won SONG
Deputy Director
Ministry of Food and Drug Safety
Republic of Korea
Regulatory Authority
Member: Mr. Se Kyung KIM
Assistant Director
Ministry of Food and drug Safety
Republic of Korea
Regulatory Authority
Member: Mr. Peter Kyong-Ho LEE
Manager
International Regulatory Affairs
Institut Straumann AG
Basel
Industry
Member: Ms. Linda LIN
Boston Scientific
Industry
Member: Dr. Xianqiang MI
Associate Professor
University of Shanghai for Science and Technology
Shanghai
People's Republic of China
Industry
Member: Honglei SUN
Clinical Affairs Manager
Medtronic
People's Republic of China
Industry
Member: Loi VU THI
Johnson & Johnson
Vietnam
Industry
Member: Ms. Yuhong, Amber WANG
RA Director
Medtronic
People's Republic of China
Industry
Member: Ms. Woei Jiuang WONG
Director
Medical Device Branch 
Pre-Marketing Division
Health Products Regulation Group
Health Sciences Authority
Industry
Member: Ms. Jirui, Carol YAN
RA Director
Johnson & Johnson Medical
People's Republic of China
Industry
Member: Mr. SINGH Kanwarjit
VP, Medical & Clinical Affairs and Development
Johnson & Johnson Medical Asia Pacific
Singapore
Industry
Member: Ms. Shiwani Zalpuri
Associate Regulatory Affairs India & South Asia
Abbott Healthcare Pvt. Ltd.
India
Industry
Member:

Ms. Ahong Freda JIANG
Director, Regulatory Affairs
BD
People's Republic of China

Industry
Member:

Dr. WILKINSON Anthony
General Manager
Cook Asia Limited
Hong Kong SAR, China

Industry
Member: Dr. WANG Dong Yan, Tony 
Clinical Affairs Manager
Cook Medical (China)
People's Republic of China
Industry
Member: Dr. SANDJAJA Cristina
General Manager
PT Prodia Diagnostic Line
Indonesia
Industry
Member: Dr. Qian Liang
Head of Medical Devices, APAC
BSI
Hong Kong
Industry
Member:

Mr. Gaurav Verma
Principal Consultant
Asia Actual India (OPC) Private Limited
India

Industry
Member: Mr. Asma Zuberi
Regulatory Manager
Medical Device & Diagnostics
Johnson & Johnson
Pakistan
Industry
Member: Ms. Ye GUO
Regulatory Affairs
Johnson & Johnson Medical (Shanghai) Ltd
People's Republic of China
Industry
Member: Ms. Yan FENG
Sr Manager
Government & Regulatory Affairs
Philips Healthcare
People's Republic of China
Industry
Member:

Mr. Justin YOO
RA,QA, and Reimbursement & Health Economics
St.Jude Medical
Republic of Korea

Industry
Member: Ms. Mie Ohama
Clinical Quality Manager APAC Medtronics
Coporate Clinical Quality & Compliance
Australia
Industry
Member: Ms. Sang Hag LEE
R&D Center Director
MEKICS Co., Ltd
Republic of Korea
Industry
Member: Ms. Jung Hyun SUNG
Manager
Corentec Co., Ltd
Industry