WG5 Clinical Evidence for Performance and Safety | ||
|---|---|---|
| Chair: |
Email: aidahwaty@mda.gov.my | Regulatory Authority |
| Co-Chair: | Ms. Ong Yean Ting Email: yean_ting.ong@roche.com | Industry |
| Secretary: | Ms. Mie Ohama Compliance Manager, Audit Management GQC Quality and Enterprise Learning PPD Australia | Industry |
| Advisor: | Ms Shelley Tang Principal Stellar consulting Australia | Industry |
| Advisor: | Dr. A. Devitt Martin Managing Director Lifecycle Medical Australia | Industry |
| Member: | Mr. Abdullah Salem AL-DOBAIB Executive Director of Registration and Licensing Department Medical Device Sector Saudi Food & Drug Authority Kingdom of Saudi Arabia | Regulatory Authority |
| Member: | Dr. Mariammah KRISHNASAMY Senior Assistant Director of Premarket Division Medical Device Authority Ministry of Health Malaysia Malaysia | Regulatory Authority |
| Member: | Mr. SIU Hiu Fai Stanley Engineer Electrical and Mechanical Services Department Government of the Hong Kong Special Administrative Region Hong Kong SAR, China | Regulatory Authority |
| Member: | Dr. Chi Won SONG Deputy Director Ministry of Food and Drug Safety Republic of Korea | Regulatory Authority |
| Member: | Mr. Se Kyung KIM Assistant Director Ministry of Food and drug Safety Republic of Korea | Regulatory Authority |
| Member: | Hsiau-Wen HUANG Senior Researcher Ministry of Health and Welfare Chinese Taipei | Regulatory Authority |
| Member: | Dr. Rongzhi Liu Reviewer of Clinical Evaluation and Biostatistics Division II Center for Medical Device Evaluation (CMDE) of NMPA People's Republic of China | Regulatory Authority |
| Member: | Ms. Li FANG Reviewer of Clinical Evaluation and Biostatistics Division II Center for Medical Device Evaluation (CMDE) of NMPA People's Republic of China | Regulatory Authority |
| Member: | Ms. Shan JU Technical Reviewer Center for Medical Device Evaluation (CMDE) of NMPA People's Republic of China | Regulatory Authority |
| Member: | Mr. Christian Natalis Kapinga Medical Devices Officer Tanzania Medicines and Medical Devices Authority Tanzania | Regulatory Authority |
| Member: | Ms. Shiwani Zalpuri Regulatory Affairs GE Healthcare India | Industry |
| Member: | Dr. Qian Liang Head of Medical Devices, APAC BSI Hong Kong | Industry |
| Member: | Ms. Asma Zuberi Senior Regulatory Affairs Specialist Gulf & Pakistan Baxter A.G Scientific Office | Industry |
| Member: | Mr. Justin YOO Professor & Head Dongguk University & A bio Medical Venture Firm Republic of Korea | Industry |
| Member: | Ms. Sang Hag LEE R&D Center Director Mekics Co., Ltd Republic of Korea | Industry |
| Member: | Mr. Chi Keung Alexis KWAN Quality Manager VTech Communications Ltd. Hong Kong | Industry |
| Member: | Ms. Rena HAN Sr. Regulatory Affair Director Boston Scientific People's Republic of China | Industry |
| Member: | Ms. Wenny Budiyanti Sr. Regulatory Affair Director Regulatory Affairs Specialist PT. Mindray Medical Indonesia Indonesia | Industry |
| Member: | Ms. Jean Lei Regulatory Affairs Manager Shenzhen Mindray Biomedical Electronics Co., Ltd. People's Republic of China | Industry |
| Member: | Mr. Leonard Hovestadt EU Director Governmental Affairs Elekta Netherlands | Industry |
| Member: | Ms. Amber Wang VP, Regulatory Affairs and Quality Assurance, Genesis MedTech Group People's Republic of China | Industry |
| Member: | Ms. Yi Gu Associate Director, Regulatory Affairs, Johnson & Johnson Medical Shanghai People's Republic of China | Industry |
| Member: | Ms. Linmeng Dong Senior Regulatory Affairs Manager Medtronic People's Republic of China | Industry |
| Member: | Dr. Jai-Yen Chen Section Chief Center For Drug Evaluation Chinese Taipei | Industry |
| Member: | Mr. Wei Zhang Sr. Clinical Trial Manager Siemens Healthineers Diagnostics (Shanghai) Co., Ltd. People's Republic of China | Industry |
| Member: | Ms. Li Zhang Sr. Clinical Manager Siemens Healthineers People's Republic of China | Industry |
| Member: | Ms. Ning Tian Clinical Porfolio Lead Roche Diagnostics People's Republic of China | Industry |
| Member: | Ms. Qiuyun Zhao Senior Regulatory Affairs Specialist Elekta Beijing Medical Systems Co. Ltd. People's Republic of China | Industry |
| Member: | Mr. Masaki Sakakibara Associate Director, Regulatory Affairs Division, Regulatory Affairs & Quality Assurance, Sysmex Corporation Japan | Industry |
| Member: | Dr. Michael Lee Head of Cardiology Queen Elizabeth Hospital Hong Kong SAR, China | Others |