Submitted by admin on Fri, 06/02/2017 - 16:44

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. Alex CHOI
Senior 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

 

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

Adverse Event Reporting Timelines Guidance for Medical Device Manufacturer and its Authorised Representative_ FINAL

Final_GHWP_WG2_F001_2013

GHWP-WG2-PMS-002_FINAL 

GHWP-WG2-PMS-003_FINAL

GHWP_WG02_PMS_Survey

GHWP_WG2_SADS_001

GHWP_WG2_SADS_002


Work Plan and Target: 

GHWP_TC_WG02_Work Plan 2012-2014