Work Group 4 (WG4) - Post-Market

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

Chair:

Mr. Yorkie CHOW
Senior Electronics Engineer
Medical Device Division
Department of Health
Hong Kong SAR, China

Regulatory Authority
Co-Chair:

Ms. Kitty MAO
RA Director
GE Healthcare
Singapore

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. Wesley Lam
Electronic 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. 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: Dr. Christopher CHAN
Office of Medical Device Evaluation
Center for Measurement Standards
Industrial Technology Research Institute
Chinese Taipei
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
 


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_AHWP_WG2_F001_2013

AHWP-WG2-PMS-002_FINAL 

AHWP-WG2-PMS-003_FINAL

AHWP_WG02_PMS_Survey

AHWP_WG2_SADS_001

AHWP_WG2_SADS_002


Work Plan and Target: 

AHWP_TC_WG02_Work Plan 2012-2014