Submitted by admin on Fri, 06/02/2017 - 16:44
Acting Chair:

Dr. Mohammed Majrashi
Executive Director of surveillance and biometric
Saudi Food & Drug Authority
Kingdom of Saudi Arabia

Email: mymajrashi@sfda.gov.sa 

Regulatory Authority

Co-Chair:

Ms. Ong Yean Ting
Head
Quality and Regulatory
Roche Diagnostics Malaysia Sdn Bhd

Email: yean_ting.ong@roche.com

Industry

Secretary:

Ms. Mie Ohama
Compliance Manager, Audit Management GQC
Quality and Enterprise Learning
PPD
Australia

Industry
Advisor: Ms Shelley Tang
Principal
Stellar consulting
Australia
Industry
Advisor: Dr. A. Devitt Martin
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: Dr. Mariammah KRISHNASAMY
Senior Assistant Director of Premarket Division
Medical Device Authority
Ministry of Health Malaysia
Malaysia
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: Hsiau-Wen HUANG
Senior Researcher
Ministry of Health and Welfare
Chinese Taipei
Regulatory Authority
Member: Ms. Stephanie Shedd
International Affairs Policy Analyst
Food and Drug Administration
Center for Devices and Radiological Health
USA
Regulatory Authority
Member: Dr. Rongzhi Liu
Reviewer of Clinical Evaluation and Biostatistics Division II
Center for Medical Device Evaluation (CMDE) of NMPA
People's Republic of China
Regulatory Authority
Member: Ms. Li FANG
Reviewer of Clinical Evaluation and Biostatistics Division II
Center for Medical Device Evaluation (CMDE) of NMPA
People's Republic of China
Regulatory Authority
Member: Ms. Shan JU
Technical Reviewer
Center for Medical Device Evaluation (CMDE) of NMPA
People's Republic of China
Regulatory Authority
Member: Mr. Christian Natalis Kapinga
Medical Devices Officer
Tanzania Medicines and Medical Devices Authority
Tanzania
Regulatory Authority
Member: Ms. Shiwani Zalpuri
Regulatory Affairs
GE Healthcare
India
Industry
Member: Dr. Qian Liang
Head of Medical Devices, APAC
BSI
Hong Kong
Industry
Member: Ms. Asma Zuberi
Senior Regulatory Affairs
Specialist 
Gulf & Pakistan
Baxter A.G Scientific Office
Industry
Member:

Mr. Justin YOO
Professor & Head
Dongguk University & A bio Medical Venture Firm 
Republic of Korea

Industry
Member: Ms. Sang Hag LEE
R&D Center Director
Mekics Co., Ltd
Republic of Korea
Industry
Member: Mr. Chi Keung Alexis KWAN
Quality Manager
VTech Communications Ltd.
Hong Kong
Industry
Member: Ms. Rena HAN
Sr. Regulatory Affair Director
Boston Scientific 
People's Republic of China
Industry
Member: Ms. Wenny Budiyanti
Sr. Regulatory Affair Director
Regulatory Affairs Specialist
PT. Mindray Medical Indonesia
Indonesia
Industry
Member: Ms. Jean Lei
Regulatory Affairs Manager
Shenzhen Mindray Biomedical Electronics Co., Ltd.
People's Republic of China
Industry
Member: Mr. Leonard Hovestadt
EU Director Governmental Affairs Elekta
Netherlands
Industry
Member: Ms. Amber Wang
VP, Regulatory Affairs and Quality Assurance, Genesis MedTech Group
People's Republic of China
Industry
Member: Ms. Yi Gu
Associate Director, Regulatory Affairs, Johnson & Johnson Medical Shanghai
People's Republic of China
Industry
Member: Ms. Linmeng Dong
Senior Regulatory Affairs Manager
Medtronic
People's Republic of China
Industry
Member: Dr. Jai-Yen Chen
Section Chief
Center For Drug Evaluation
Chinese Taipei
Industry
Member: Mr. Wei Zhang
Sr. Clinical Trial Manager
Siemens Healthineers Diagnostics (Shanghai) Co., Ltd.
People's Republic of China
Industry
Member: Ms. Li Zhang
Sr. Clinical Manager 
Siemens Healthineers
People's Republic of China
Industry
Member: Ms. Ning Tian
Clinical Porfolio Lead
Roche Diagnostics
People's Republic of China
Industry
Member: Ms. Qiuyun Zhao
Senior Regulatory Affairs Specialist
Elekta Beijing Medical Systems Co. Ltd.
People's Republic of China
Industry
Member: Mr. Masaki Sakakibara
Associate Director, Regulatory Affairs Division, Regulatory Affairs & Quality Assurance, Sysmex Corporation
Japan
Industry

 

Work Plan and Target: 

GHWP_TC_WG05_Work Plan 2012-2014