Chair: |
Dr. Ambrose Chi Hong Wong Email: chi_hong_wong@dh.gov.hk |
Regulatory Authority |
Co-Chair: |
Ms. Kitty MAO Email: kitty.mao@ge.com |
Industry |
Advisor: | Prof. Pei Gao Director, Centre of Real-world Evidence Evaluation (Creation), Peking University Clinical Research Institute Peking University People's Republic of China |
Others (Academy) |
Member: | Ms. Althea LAU Scientific Officer Medical Device Division Department of Health Hong Kong SAR, China |
Regulatory Authority |
Member: | Mr. Karl LEUNG Electronics Engineer Medical Device Division Department of Health Hong Kong SAR, China |
Regulatory Authority |
Member: | Mr. Ahmed Alqami Director of Surveillance Surveillance and Biometrics, Saudi Food and Drug Authority Kingdom of Saudi Arabia |
Regulatory Authority |
Member: | Ms. Aisha Al-Ghaithi Section Head of Medical Device Vigilance Ministry of Health Muscat, Sultanate of Oman |
Regulatory Authority |
Member: | Mr. Abdulmohsen Al-Hajlan Post-Market Clinical Evaluation Section Head Saudi Food and Drug Authority Kingdom of Saudi Arabia |
Regulatory Authority |
Member: | Ms. Sara Alharthi Senior Clinical Evaluation Specialist Saudi Food and Drug Authority Kingdom of Saudi Arabia |
Regulatory Authority |
Member: | Ms. Xiaoxue Wang Deputy Consultant National Medical Products Administration,Department of Medical Device Regulation People's Republic of China |
Regulatory Authority |
Member: | Ms. Rui Zhi Medical Device Evaluator Center for Drug Reevaluation, NMPA People's Republic of China |
Regulatory Authority |
Member: | Ms. Yana Song Medical Device Evaluator Center for Drug Reevaluation, NMPA People's Republic of China |
Regulatory Authority |
Member: | Mr. Alex CHOI Senior Electronics Engineer Medical Device Division Department of Health Hong Kong SAR, China |
Regulatory Authority |
Member: | Mr. Dong Li Staff Center for Drug Reevaluation, NMPA People's Republic of China |
Regulatory Authority |
Member: | Ms. Yan Zhao Deputy Director of Department of Medical Device Monitoring and Evaluation Center for Drug Reevaluation, NMPA People's Republic of China |
Regulatory Authority |
Member: | Dr. Adel Alhajji Senior Biomedical Engineer-Consultant in the Office of the Under Secretary of Medicines & Medical Equipments Ministry of Health State of Kuwait |
Regulatory Authority |
Member: | Mr. David Matle Medical Devices Officer-PMS & Vigilance Section Tanzania Medicines and Medical Devices Authority Tanzania |
Regulatory Authority |
Member: | Mr. Kazimil Kishosha Medical Devices Officer Tanzania Medicines and Medical Devices Authority Tanzania |
Regulatory Authority |
Member: |
Ms. Rose Zakaria Maingu Medical Devices Officer Tanzania Medicines and Medical Devices Authority Tanzania |
Regulatory Authority |
Member: | Mr. Mohd Zul Hirsham Junaidi Principal Assistant Director Medical Device Authority, Ministry of Health Malaysia Malaysia |
Regulatory Authority |
Member: | Ms. Norshafina Sahinin Senior Assistant Director Medical Device Authority, Ministry of Health Malaysia Malaysia |
Regulatory Authority |
Member: | Ms. Nur Hazreen Abdul Razak Senior Assistant Director Medical Device Authority, Ministry of Health Malaysia Malaysia |
Regulatory Authority |
Member: | Prof. Raul Yañez Vega Surveillance Section, Department of Medical Devices Center for State Control of Medicines (CECMED) Cuba |
Regulatory Authority |
Member: | Ms. Laleetha DEVI Asia Pacific RAQA Director O&M Halyard Malaysia |
Industry |
Member: | Ms. Terrenz LEUNG RA & QA Manager Abbott Vascular Hong Kong SAR, China |
Industry |
Member: | Ms. Carrie LI Regulatory Affairs Supervisor and Quality Assurance Manager Cook Asia Ltd Hong Kong SAR, China |
Industry |
Member: |
Mr. Tony YIP |
Industry |
Member: | Dr. Henry Hou Head of Regulatory Affairs, Asia Pacific Elekta Limited Hong Kong SAR, China |
Industry |
Member: | Ms. Chueh-pin CHEN Team Leader of Division of Drug Safety Taiwan Drug Relief Foundation/ Taiwan National ADR Reporting Center Chinese Taipei |
Industry |
Member: | Ms. Jacqin Cui Regulatory Affairs Director Abbott People's Republic of China |
Industry |
Member: | Mr. Wentao WANG Prin. MDR/Vigilance Specialist Medtronic People's Republic of China |
Industry |
Member: | Ms. Amy Li Senior Vice President of Quality and Regulatory Affairs Guangzhou Wondfo Biotech Co. LTD. People's Republic of China |
Industry |
Member: | Ms. Lu She Head of QM Siemens Shenzhen Magnetic Resonance People's Republic of China |
Industry |
Member: | Ms. Wella Wei China RAQA Director Align Technology Co. Ltd. People's Republic of China |
Industry |
Member: | Ms. Carol LIU Associate Director, IncuBio and Medical Devices, Institute for Translational Research (Biomed Tech) Hong Kong Science and Technology Parks Corporation Hong Kong SAR, China |
Industry |
Member: | Ms. Elva Shang Regulatory Director, APAC & MEA Region Allgergan Aesthetics People's Republic of China |
Industry |
Member: | Ms. Huijuan Li Deputy Director, Center for Real -World Evidence Evaluation Peking University Clinical Research Institute People's Republic of China |
Others (Academy) |
Member: | Prof. Xun Tang Associate Professor Peking University School of Public Health People's Republic of China |
Others (Academy) |
Post Market Resource Center (PMRC)- Tool developed by Work Group 4 of GHWP
Guidance Documents:
FINAL_Guidelines for adverse event reporting of PCI device_20161013
Work Plan and Target:
GHWP_TC_WG02_Work Plan 2012-2014