| 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 |
| 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. 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 |
Industry |
| Member: |
Prof. Jack WONG |
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 |
WG9/ STG Documents
1. GHWP/STG(LE)/001A
Title: Global Harmonization Working Party (GHWP) & Global Harmonization Working Party Technical Committee (GHWPTC) - Terms of Reference (Amendment 1)
Date: 30 Nov 2010
GHWP-STGLE-1A@30Nov2010(Final).pdf
2. GHWP/STG(LE)/002
Title: GHWP STGLE002-GHWP Adm Services Ltd (Proposed Final Document)
Date: 7 June 2010
GHWP STGLE002-GHWP Adm Services Ltd _Final Document_.pdf
3. GHWP/STG(LE)/001
Title: Global Harmonization Working Party (GHWP) & Global Harmonization Working Party Technical Committee (GHWPTC) - Terms of Reference
Date: 6 Sep 2009
GHWP_STGLE_001.pdf
Work Plan and Target:
GHWP_TC_STG(N)_Work Plan 2012-2014