WG9 - UDI & Nomenclature

Chair: Ms. Jun LI
Division Director of Medical Device Registration
Medical Device Registration Department
China Food and Drug Administration
People's Republic of China
Regulatory Authority
Co-Chair:

Ms. Victoria QU
Director Regulatory Affairs
Global Strategic Regulatory Abbott 
People's Republic of China

Industry
Secretary: Nil  
Member: Mr. Azzam ALOTHMAN
Director of Quality & Risk
Saudi Food & Drug Authority
Kingdom of Saudi Arabia
Regulatory Authority
Member: Mr. Gao Tong ZHANG
Deputy Director
International Cooperation Department
China Food & Drug Authority
People's Republic of China
Regulatory Authority
Member: Ms. Yuwadee PATTANAWONG
Director
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: Mr. Li YI
Research Assistant
National Institute for Food and Drug Control
People's Republic of China
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 and Compliance
Smith & Nephew
People's Republic of China
Industry
Member: Mr. Ed Woo
RA Director
ASPAC
Varian
Hong Kong SAR, China
Industry
Member: Dr. Lindsay TAO
Corporate Director
Global Health Policy
Johnson & Johnson
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:

Ms. Sheryl HSIAO
Regulatory Affairs and Compliance Manager BD
Chinese TaiTaiwan & Hong Kong SAR

Industry
Member: Ms. Jennifer HAN
RA Director, 3M
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: Ms. Jocelyn YEN
Regional Regulatory Affairs Manager (APAC)
Biosensors Interventional Technologies Pte Ltd
Singapore
Industry
Member: Ms Sun Bin HWANG
Associate RA Director
RALI Johnson & Johnson
Vision Care
Republic of Korea
Industry
Member: Mr. Kyungyoon KANG
Regulatory Affairs Manager
Cardinal Health
United States of America
Industry
Member:

Ms. Liang YAN
Chair
Shanghai Pudong Medical Device Trade Association
People's Republic of China


Observer:

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

Industry
Observer: Mr. Kyungyoon KANG
Regulatory Affairs Manager
Cardinal Health
United States of America
Industry

 

 

STG Documents

 

1. AHWP/STG(LE)/001A

Title: Asian Harmonization Working Party (AHWP) & Asian Harmonization Working Party Technical Committee (AHWPTC) - Terms of Reference (Amendment 1)

Date: 30 Nov 2010

Download file:AHWP-STGLE-1A@30Nov2010(Final).pdf

 

2. AHWP/STG(LE)/002

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

Date: 7 June 2010

Download file:AHWP STGLE002-AHWP Adm Services Ltd _Final Document_.pdf

 

3. AHWP/STG(LE)/001

Title: Asian Harmonization Working Party (AHWP) & Asian Harmonization Working Party Technical Committee (AHWPTC) - Terms of Reference

Date: 6 Sep 2009

AHWP_STGLE_001.pdf