Chair: |
Dr. Ambrose Chi Hong Wong |
Regulatory Authority |
Co-Chair: |
Ms. Kitty MAO |
Industry |
Advisor: | Dr. Jorge GARCIA Principal Scientific Adviser Medical Devices Branch Therapeutic Goods Administration Australia |
Regulatory Authority |
Advisor: | Ms. Joanna KOH Principal Consultant MDnet Regulatory Consultants Singapore |
Industry |
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. 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 |
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. Lan Hoon SEOW |
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 |
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