| Chair: | Mr. Park Seil 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 |
Industry |
| Advisor: |
Dr. Arthur BRANDWOOD |
Industry |
| Secretary: |
Ms. Yon Ju, KANG |
Industry |
| Member: | Mr. Essam Mohammed AI Mohandis Executive Director |
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: | Ms. Faiza ALZADJALI Director of Medical Device Control Ministry of Health Oman |
Regulatory Authority |
| Member: | Mr. Samwel Hhayuma Biomedical Engineer Tanzania Food & Drugs Authority 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: | Mr. Gulnar Berkimbayeva Head of Department of Primary Expertise Medical Devies 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 Republic of Indonesia |
Regulatory Authority |
| Member: | Ms. Sookyeong Shin Departmen 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. Jason Guo |
Industry |
| Member: |
Mr. Grant BENNETT
Director & CEO Brandwood Biomedical People's Republic of China |
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: | Mr. Pavan Kumar Malwade Manager, Regulatory Affairs CARIn Division Carl Zeiss India (Bangalore) Pvt. |
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 |
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 Becton Dickinson Singapore |
Industry |
| Member: |
Ms Youngsoon Jeon |
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 |
Guidance Documents:
FINAL_GHTF SG1 Definition of the Terms
FINAL_AHWP_WG_Proposed_Final_Comb_ Prod_Guidance-241116
Work Plan and Target:
AHWP_TC_WG01_Work Plan 2012-2014