WG9 UDI & Nomenclature
WG9 UDI & Nomenclature | ||
|---|---|---|
| Chair: | Ms. Zhou Wenwen Email: zhouww@nmpa.gov.cn | Regulatory Authority |
| Co-Chair: | Ms. Lilo (Meng) Li Email: lilo_li@bd.com | Industry |
| Secretary: | Mr. Li YI Research Assistant National Institute for Food and Drug Control People's Republic of China | Regulatory Authority |
| Advisor: | Dr. Barry Daniels Clinical Lead GMDN Agency United Kingdom | Others |
| Member: | Mr. Azzam ALOTHMAN Director of Quality & Risk Saudi Food & Drug Authority Kingdom of Saudi Arabia | Regulatory Authority |
| Member: | Mrs. Korrapat TRISARNSRI Director of Medical Device Control Division Medical Devices Control Division Food and Drug Administration Thailand | Regulatory Authority |
| Member: | Dr. Rama SETHURAMAN Senior Regulatory Specialist Medical Device Branch Pre-Marketing Division Health Products Regulation Group Health Sciences Authority Singapore | Regulatory Authority |
| Member: | Mr. Mesha'l Alamri Executive Director Premarket Approval & Scientific Evaluation Management Medical Device Sector Saudi Food & Drug Authority Kingdom of Saudi Arabia | Regulatory Authority |
| Member: | Ms. Cheng-Ning WU Section Chief Food and Drug Administration Ministry of Health and Welfare Chinese Taipei | Regulatory Authority |
| Member: | Mr. Li YI Research Assistant National Institute for Food and Drug Control People's Republic of China | Regulatory Authority |
| Member: | Ms. Yuxi Yang Reviewer Center for Medical Evaluation, NMPA People's Republic of China | Regulatory Authority |
| Member: | Ms. Aidahwaty M.Olaybal Director of Division (Pre-Market Control) Medical Device Authority Malaysia | Regulatory Authority |
| Member: | Ms. Buthaina Mohammed Albalushi Biomedical engineer Ministry of Health Sultanate of Oman | Regulatory Authority |
| Member: | Dr. Shani Maboko Medical Devices Officer Tanzania Medicines and Medical Devices Authority (TMDA) Tanzania | Regulatory Authority |
| Member: | Dr. Shang-Ching Lin Associate Researcher Taiwan Food and Drug Administration Chinese Taipei | Regulatory Authority |
| Member: | Dr. Xianqiang MI Professor Shanghai Advanced Research Institute Chinese Academy of Science People's Republic of China | Industry |
| Member: | Ms. Amber WANG Vice President, Regulatory Affairs & Quality Assurance Genesis MedTech Group People's Republic of China | Industry |
| Member: | Ms. LI Meng Associate Director of Regulatory Affairs Becton Dickinson and Company Beijing, People's Republic of China | Industry |
| Member: | Ms. LI Meng Associate Director of Regulatory Affairs Becton Dickinson and Company Beijing, People's Republic of China | Industry |
| Member: | Ms. Mary WANG Johnson & Johnson Vision Care (Shanghai) Ltd. People's Republic of China | Industry |
| Member: | Ms. Jing SU RA Director Sysmex People's Republic of China | Industry |
| Member: | Mr. Sean GAO Associate RA Director Metronic People's Republic of China | Industry |
| Member: | Mr. Johnny Wu Office of Medical Devices Evaluation Center for Measurement Standards Industrial Technology Research Institute Chinese Taipei | Industry |
| Member: | Mr. Kevin ORR Group Vice President Winner Medical Group Hong Kong SAR, China | Industry |
| Member: | Mr. CUI Jun RI and RA Operation Director GE Healthcare People's Republic of China | Industry |
| Member: | Mr. GAO Xin Regulatory Affairs Manager Shanghai United Imaging Healthcare Co., Ltd.n People's Republic of China | Industry |
| Member: | Mr. WANG Xinbing Regulatory Director Shenzhen Mindray Bio-Medical Electronic Co., Ltd People's Republic of China | Industry |
| Member: | Mr. ZHAO Jie Jason Associate Director, Regulatory Affairs Johnson & Johnson Medical Shanghai People's Republic of China | Industry |
| Member: | Ms. WANG Xuejing Co-founder & Deputy general manager Beijing Jawa-Huicheng Technology Co.,Ltd. People's Republic of China | Industry |
| Member: | Mr. Alex Jiang QA/RA VP Fosun Diagnostics (Shanghai) Ltd People's Republic of China | Industry |
| Member: | Ms. Victoria Qu Director, Quality and Regulatory Affairs Asia Pacific, Cordis People's Republic of China | Industry |
| Member: | Mr. Junyou Chu QRA Director Medtronic (Shanghai) Co. LTD. People's Republic of China | Industry |
| Member: | Mr. Yihua Cao Regulatory Affiars Asahi Kasei Medical Co., Ltd Japan | Industry |
| Member: | Ms. Minghua Chen Business Development Manager Asia Pacific | Senior Consultant Qserve Group China, Ltd. People's Republic of China | Industry |
| Member: | Mr. Hengkun Zhao Associate Director Shandong Weigao Group Medical Polymer Co. Ltd People's Republic of China | Industry |
| Member: | Ms. Lotus Cai Sr. Quality Lead Roche Diagnostics (Shanghai) Limited People's Republic of China | Industry |
| Member: | Ms. Ran Li Senior Engineer, Quality Assurance Shanghai MicroPort Medical (Group) Co., Ltd. People's Republic of China | Industry |
| Member: | Ms. Yang Liu Regulatory Affairs Compliance Manager Abbott Vascular People's Republic of China | Industry |