| Chair: |
Ms. Aidahwaty M. Olaybal Email: aidahwaty@mda.gov.my |
Regulatory Authority |
Co-Chair: |
Ms. Ong Yean Ting Email: yean_ting.ong@roche.com |
Industry |
Secretary: |
Ms. Mie Ohama |
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 |
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 |
Work Plan and Target:
GHWP_TC_WG05_Work Plan 2012-2014