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 FDA
Saudi Arabia
Regulatory Authority
Member: Ms. Nancy PRESSLY
Policy Analyst
Office of Regulatory Programs
Center for Devices and Radiological Health, US Food and Drug Administration
United States of America
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: 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. Yoo Nah CHOI
Senior Manager of Bussiness Quality
Johnson & Johnson Medical Korea Limited
Republic of Korea

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. Lan Hoon SEOW
Director, Regulatory Affairs, Asia Pacific
Ansell Shah Alam Sdn Bhd
Malaysia

Industry

Member: Ms. Jackeline CHAN
Market Access Manager
MEDI-GLOBE GmBH
Hong Kong SAR, China
Industry
Member: Ms. Lois YEUNG
Senior Regulatory Affairs & Medical Affairs Officer
B. Braun Medical (HK) Ltd
Hong Kong SAR, China

Industry

Member: Mr. Ricky Ho
Manager
Professional Quality & Regulatory
Hong Kong SAR, China
Industry
Member: Ms. Ching Yee LAW
Regulatory Affairs and Quality Compliance Manager
Abbott Laboratories (M) Sds. Bhd.
Malaysia
Industry
Member: Ms. Judy CHEUNG
Regulatory Affairs Manager
Fujirebio Asia Pacific Pte Ltd
Singapore
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: Mr. Prashanth SRIRANGAM
Sr. Manager-QA
Healthium Medtech Ltd.
India
Industry
Member: Ms. Jin 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

 

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