Submitted by admin on Fri, 06/02/2017 - 16:53
Chair:

Ms. Zhou Wenwen
Deputy Director
Medical Device Registration Department
National Medical Products Administration (NMPA)
People's Republic of China

Email: zhouww@nmpa.gov.cn

Regulatory Authority

Co-Chair:

Ms. Lilo (Meng) Li
Associate Regulatory Affairs Director
Becton Dickinson and Company

Email: lilo_li@bd.com

Industry
Secretary: Mr. Li YI
Research Assistant
National Institute for Food and Drug Control
People's Republic of China
Regulatory Authority
Member: Mr. Azzam ALOTHMAN
Director of Quality & Risk
Saudi Food & Drug Authority
Kingdom of Saudi Arabia
Regulatory Authority

Member:
Mrs. Korrapat TRISARNSRI
Director of Medical Device Control Division
Medical Devices Control Division
Food and Drug Administration
Thailand
Regulatory Authority
Member: Dr. Rama SETHURAMAN
Senior Regulatory Specialist
Medical Device Branch
Pre-Marketing Division
Health Products Regulation Group
Health Sciences Authority
Singapore
Regulatory Authority
Member: Mr. Mesha'l Alamri
Executive Director
Premarket Approval & Scientific Evaluation Management
Medical Device Sector
Saudi Food & Drug Authority
Kingdom of Saudi Arabia
Regulatory Authority
Member: Ms. Cheng-Ning WU
Section Chief
Food and Drug Administration
Ministry of Health and Welfare
Chinese Taipei
Regulatory Authority
Member: Mr. Li YI
Research Assistant
National Institute for Food and Drug Control
People's Republic of China
Regulatory Authority
Member: Ms. Indira KONDURI
Deputy Director, Division of Surveillance Support, Office of Regulatory Programs, Office of Product Evaluation & Quality, Center for Devices & Radiological Health
US Food & Drug Administration
USA
Regulatory Authority
Member: Ms. Yuxi Yang
Reviewer
Center for Medical Evaluation, NMPA
People's Republic of China
Regulatory Authority
Member: Ms. Aidahwaty M.Olaybal
Director of Division (Pre-Market Control)
Medical Device Authority
Malaysia
Regulatory Authority
Member: Ms. Buthaina Mohammed Albalushi
Biomedical engineer
Ministry of Health
Sultanate of Oman
Regulatory Authority
Member: Dr. Shani Maboko
Medical Devices Officer
Tanzania Medicines and Medical Devices Authority (TMDA)
Tanzania
Regulatory Authority
Member: Dr. Xianqiang MI
Professor
Shanghai Advanced Research Institute
Chinese Academy of Science
People's Republic of China
Industry
Member: Ms. Amber WANG
Vice President, Regulatory Affairs & Quality Assurance
Genesis MedTech Group
People's Republic of China
Industry
Member:

Ms. LI Meng
Associate Director of Regulatory Affairs
Becton Dickinson and Company
Beijing, People's Republic of China

Industry
Member:

Prof. Jack WONG
Head of Regulatory Affairs - Life Sciences, APAC
Baxter Healthcare (Asia) Pte. Ltd.
Hong Kong SAR, China

Industry
Member: Mr. Hemangini(HEMA) PATEL (SHROFF)
Senior Manager
International Regulatory Affairs
Church & Dwight Co. Inc,
Princeton, United States of America
Industry
Member: Ms. Mary WANG
Johnson & Johnson Vision Care (Shanghai) Ltd.
People's Republic of China
Industry
Member: Ms. Jing SU
RA Director
Sysmex
People's Republic of China
Industry
Member: Mr. Sean GAO
Associate RA Director
Metronic
People's Republic of China
Industry
Member: Mr. Johnny Wu
Office of Medical Devices Evaluation
Center for Measurement Standards
Industrial Technology Research Institute
Chinese Taipei
Industry
Member: Mr. Kyungyoon KANG
Regulatory Affairs Manager
Cardinal Health
United States of America
Industry
Member: Mr. Kevin ORR
Group Vice President
Winner Medical Group
Hong Kong SAR, China
Industry
Member: Mr. Dennis BLACK
UDI Program Director
BD
USA
Industry
Member: Mr. CUI Jun
RI and RA Operation Director
GE Healthcare
People's Republic of China
Industry
Member: Mr. GAO Xin
Regulatory Affairs Manager
Shanghai United Imaging Healthcare Co., Ltd.n
People's Republic of China
Industry
Member: Mr. WANG Xinbing
Regulatory Director
Shenzhen Mindray Bio-Medical Electronic Co., Ltd
People's Republic of China
Industry
Member: Mr. ZHAO Jie Jason
Associate Director, Regulatory Affairs
Johnson & Johnson Medical Shanghai
People's Republic of China
Industry
Member: Ms. WANG Xuejing
Co-founder & Deputy general manager
Beijing Jawa-Huicheng Technology Co.,Ltd.
People's Republic of China
Industry
Member: Mr. Alex Jiang
QA/RA VP
Fosun Diagnostics (Shanghai) Ltd
People's Republic of China
Industry
Member: Mr. Parth Dave
Assciate Director of Regulatory Affairs, Abbott
USA
Industry
Member: Ms. Victoria Qu
Director, Quality and Regulatory Affairs
Asia Pacific, Cordis
People's Republic of China
Industry
Member:

Ms. Tania Pearson
Regulatory System Director/ UDI Program Manager
Medtronic
United States of America

Industry
Member: Mr. Junyou Chu
QRA Director
Medtronic (Shanghai) Co. LTD.
People's Republic of China
Industry
Member: Mr. Yihua Cao
Regulatory Affiars
Asahi Kasei Medical Co., Ltd
Japan
Industry
Member: Ms. Minghua Chen
Business Development Manager Asia Pacific | Senior Consultant
Qserve Group China, Ltd.
People's Republic of China
Industry
Member: Mr. Hengkun Zhao
Associate Director
Shandong Weigao Group Medical Polymer Co. Ltd
People's Republic of China
Industry
Member: Ms. Lotus Cai
Sr. Quality Lead
Roche Diagnostics (Shanghai) Limited
People's Republic of China
Industry
Member: Ms. Ran Li
Senior Engineer, Quality Assurance
Shanghai MicroPort Medical (Group) Co., Ltd.
People's Republic of China
Industry
Member: Ms. Yang Liu
Regulatory Affairs Compliance Manager
Abbott Vascular
People's Republic of China
Industry
Observer:

Mr. Hemangini (HEMA) PATEL (SHROFF)
Senior Manager
International Regulatory Affairs Church & Dwight Co. Inc, Princeton
United States of America 

Industry

 

 

 

WG9/ STG Documents

 

1. GHWP/STG(LE)/001A

Title: Global Harmonization Working Party (GHWP) & Global Harmonization Working Party Technical Committee (GHWPTC) - Terms of Reference (Amendment 1)

Date: 30 Nov 2010

GHWP-STGLE-1A@30Nov2010(Final).pdf

 

2. GHWP/STG(LE)/002

Title: GHWP STGLE002-GHWP Adm Services Ltd (Proposed Final Document)

Date: 7 June 2010

GHWP STGLE002-GHWP Adm Services Ltd _Final Document_.pdf

 

3. GHWP/STG(LE)/001

Title: Global Harmonization Working Party (GHWP) & Global Harmonization Working Party Technical Committee (GHWPTC) - Terms of Reference

Date: 6 Sep 2009

GHWP_STGLE_001.pdf


Work Plan and Target: 

GHWP_TC_STG(N)_Work Plan 2012-2014