| Chair: |
Dr. Seil Park
Assistant Director
Division of High-Tech Medical Devices
Ministry of Food and Drug Safety
Republic of Korea |
Regulatory Authority |
| Co-Chair: |
Ms. 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 |
| WG 1 Secretary: |
Ms. Yon Ju Kang
Regulatory Affairs Manager, Korea
Johnson & Johnson Medical
Republic of Korea
|
Industry |
| 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. Samwel Hhayuma
Biomedical Engineer
Tanzania Food & Drugs Authority
Tanzania |
Regulatory Authority |
| Member: |
Mr. Gulnar Berkimbayeva
Head of Department of Primary Expertise
Medical Devices National Center
Kazakhstan |
|
Regulatory Authority |
| Member: |
Mr. Fikrisyah Bin Irman
Medical Device Evaluator, Directorate of Medical Device and Household Health Product Evaluation
Ministry of Health
Indonesia |
|
Regulatory Authority |
| Member: |
Ms. Sookyeong Shin
Department of Medical Device Evaluation
Ministry of Food & Drug Safety
Republic of Korea |
|
Regulatory Authority |
| Member: |
Ms. Ming Hao Tan
Manager
Regulatory Associates LLP
Singapore |
|
Industry |
| Member: |
Mr. Grant Bennet
Director & CEO
Brandwood Biomedical
People's Republic of China |
|
Industry |
| Member: |
Ms. Minghua Chen
BD & Sales Manager
Qserve Group China Ltd
People's Republic of China |
|
Industry |
| Member: |
Ms. Sheryl Hsiao
Regulatory Affairs and Compliance Asia Manager
3M
Singapore |
|
Industry |
| Observer: |
Dr. Peter W.J. Linders
Director, Standards & Regulations, Global Quality & Regulatory
Philips Healthcare
The Netherlands |
|
Industry |
| Member: |
Mr. Pavan Kumar Malwade
Manager, Regulatory Affairs CARIn Division
Carl Zeiss India (Bangalore) Pvt. Ltd.
India |
|
Industry |
| Member: |
Ms. Victoria Qu
Director, Regulatory Affairs
Abbott Laboratories
People's Republic of China |
|
Industry |
| Member: |
Mr. Sanoj Prabhakaran
Regulatory Affairs Manager, Middle East, North Africa & Turkey, where Oman, UAE and Saudi Arabia
Becton Dickinson
Kingdom of Saudi Arabia |
|
Industry |
| Member: |
Mr. NG Swee Choong
Sr. Engineer
Cook Asia Limited
Hong Kong SAR |
|
Industry |
| Member: |
Mr. Tony Yip
Associate Director, Regulatory Affairs, Asia Pacific
Grifols (HK) Limited
Hong Kong SAR |
|
Industry |
| Member: |
Ms. Chiew Teng Chuah
Manager, EHS & Regulatory
3M Malaysia Sdn Bhd
Malaysia |
|
Industry |
| Member: |
Mr. Edward Woo
Sr. Dir. RA, Asia Pacific
Varian Medical Systems Pacific, Inc.
Hong Kong SAR |
|
Industry |
| Member: |
Ms. Yusyanti Mat Tahir
Manager, Regulatory Affairs
Becton Dickinson
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: |
Mr. Kulveen Bali Singh
Manager - Regulatory Affairs
3M India Limited
India |
|
Industry |
| Observer: |
Mr. Keiichiro Ozawa
Regulatory Specialist, Medical Device
FUJIFILM Corporation
Japan |
|
Industry |
| Member: |
Dr. Felista Chepwogen
Head of medical devices and diagnostics department
National Medicines Regulation Officer
Kenya |
|
Regulatory Authority |
| Member: |
Ms. Faiza Said AL Zadjali Eng
Director of Medical Device Control DGPA & DC
Ministry of Health Sultanate of Oman
Sultanate of Oman |
|
Regulatory Authority |
| Member: |
Dr. Henry Hou
Regulatory Affairs Manager
Elekta Limited
Hong Kong SAR |
|
Industry |
| Member: |
Mr. Asok Kumar
Director Global Strategic Regulatory Affairs
Abbott Laboratories
India |
|
Industry |
| Member: |
Ms. Jyotsna Yadav
Sr. Manager
Smith & Nephew
Dubai, UAE |
|
Industry |
