Work Group 1 (WG1) - Pre-market: General MD

 

  

Chair: Mr. Essam Mohammed Al Mohandis
Executive Director
Surveillance and Biometrics
Saudi Food and Drug Authority
Kingdom of Saudi Arabia
Regulatory Authority
Co-Chair:

Ms. Kate HyeongJoo KIM 
Director
Regulatory Strategy & Innovation,ASPAC

Director
Regulatory Affairs, North Asia
Johnson & Johnson Medical
Republic of Korea

Industry
Secretary: Mandy Myoung Shim KIM
Senior Regulatory Affairs Manager,Korea
Johnson & Johnson Medical
Republic of Korea
Industry
Advisor:

Dr. Arthur BRANDWOOD
Principal Consultant
Brandwood Biomedical
Australia

Industry
Member: Ms. Yuwadee PATANAWONG
Senior Expert in Medical Device Safety
Medical Device Control Divison
Food and Drug Administration
Thailand
Regulatory Authority
Member: Mr. ALAMRI Mesha'l
Executive Director
Premarket & Scientific Evaluation Management
Medical Devices Sector 
Saudi Food & Drug Authority
Kingdom of Saudi Arabia
Regulatory Authority
Member: Mr. Faiza ALZADJALI
Director of Medical Device Control
Ministry of Health
Oman
Regulatory Authority
Member: Mr. Samwel Hhayuma
Biomedical Engineer
Ministry of Health and Social Welfare
Republic of Tanzania
Regulatory Authority
Member: Mr. Sung In BAEK
Assistant Director
Dental & Gastroenterology Device Division
Ministry of Food & Drug Safety
Republic of Korea
Regulatory Authority
Member: Ms. Ming Hao TAN
Manager 
Regulatory Associates LLP
Singapore
Industry
Member:

Mr. Jason Guo
APAC Director
Regulatory Affairs, Qaulity & Compliance
Abbott Vascular
Asia Pacific Region
People's Republic of China

Industry
Member: Dr. Arthur BRANDWOOD
Managing Director
Brandwood Biomedical Pty Ltd
Australia
Industry
Member:
Mr. Grant BENNETT
Manager
Regulatory Affairs, Asia Pacific
Welch Allyn Inc
Australia
Industry
Member:
Ms. Cherry CHEN
BD & Sales Manager
Qserve Group China Co., Ltd
People's Republic of China
Industry
Member:
Ms. Pei-Ting Sarah CHOU
SGS

Chinese Taipei

Industry
Member:
Ms. Sheryl HSIAO
Regulatory Affairs and Compliance Manager
BD
Chinese Taipei
Industry
Member:
Dr. Peter W.J. LINDERS
Director, Standards & Regulations
Philips Healthcare - Global Quality & Regulatory
The Netherlands
Industry
Member:
Ms. Yean Ting ONG
Johnson & Johnson Sdn Bhd
Malaysia
Industry
Member:
Ms. Victoria QU
Director, Regulatory Affairs
Global Strategic Regulatory
Abbott
People's Republic of China
Industry
Member: Mr. Sanoj PRABHAKARAN 
Regulatory Affairs Manger
Becton Dickinson, Middle East
Saudi Arabia
Industry
Member: Mr. NG Swee Choong
R&D Engineer
Cook Asia Limited
Hong Kong SAR, China
Industry
Member:

Mr. Tony YIP
Associate Director
Regulatory Affairs
APAC Grifols (HK) Limited
Hong Kong SAR, China

Industry
Member: Ms. CHUAH Chiew Teng
Product EHS & Regulatory Manager
3M Malaysia Sdn Bhd
Malaysia
Industry
Member: Dr. SEOW Lan Hoon
Regulatory Affairs Director, Asia Pacific
Ansell Shah Alam Sdn Bhd
Malaysia
Industry
Member: Ms. NG Yoke Yin
Senior Regulatory Affairs Director, Asia Pacific
Ansell Shah Alam Sdn Bhd
Malaysia
Industry
Member: Mr. Edward WOO
AP RA Director
Varian Medical Systems Pacific, Inc.
Hong Kong SAR
Industry
Member: Ms. Musliha Abdullah
QA Manager
CIBA VISION Johor Sdn Bhd
Johor, Malaysia
Industry
Member: Mr. Nishith DESAI
Director of Regulator Affairs, Asia
Covidien Private Limited
Singapore
Industry
Member: Ms Yusyanti Mat Tahir
Manager, Regulatory Affairs
Biosensors Interventional Technologies Pte Ltd
Singapore
Industry
Member:

Ms Youngsoon Jeon
Sr. RA/QA/Reimbursement Manager
RA/QA/RIP Department
Bard Korea Ltd.
Republic of Korea

Industry
Member: Mr Youngsoo SEOL
QMR
ILOODA CO., LTD.
Republic of Korea
Industry
Member: Ms Christine YU
Manager 
Regulatory Associates LLP
Singapore
Industry
Member: Mr Kulveen Bali SINGH
Manager - Regulatory Affairs
3M India Limited 
India
Industry
Member: Ms Mary WANG
Johnson & Johnson Vision Care 
Industry
Member: Ms Mandy KIM
RA Manager
Johnson & Johnson Medical 
Republic of Korea
Industry
Member: Mr. Keiichiro Ozawa
Regulatory Specialist
Medical Device
FUJIFILM Corporation
Japan
Industry

 

WG1  Documents

 

 

 1.

AHWP/WG1/F001:2014

White Paper on Medical Device -Software Qualification and Classification White Paper

Date: 21 Nov 2014

  Download file:Final_AHWP_WG1_F001_2014.pdf