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WG4 Post-Market

WG4 Post-Market

Chair:


Dr. Ambrose Chi Hong Wong
Senior Medical & Health Officer 
(Medical Device)
Medical Device Division
Department of Health
Hong Kong SAR, China

Email: chi_hong_wong@dh.gov.hk

Regulatory Authority
Co-Chair:

Ms. Kitty MAO
RA Director
GE Healthcare
Singapore

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. 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:Mr. Eric Yau
Electronics Engineer
Medical Device Division
Department of Health
Hong Kong SAR, China
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
Associate Director
Regulatory Affairs APAC
Grifols (HK) Limited
Hong Kong SAR
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
Industry
Member:Prof. Xun Tang
Associate Professor
Peking University School of Public Health
People's Republic of China
Industry