Work Group 4 (WG4) - Post-Market

Chair:

Ms. Jennifer MAK
Senior Electronics Engineer
Medical Device Control Office
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 Control Office
Department of Health
Hong Kong SAR, China
Regulatory Authority
Member: Mr. Essam Mohammed Al Mohandis
Executive Director of surveillance and biometrics
Saudi Food and Drug Authority
Kingdom of Saudi Arabia
Regulatory Authority
Member: Mr. Wesley Lam
Electronic Engineer
Medical Device Control Office
Department of Health
Hong Kong SAR, China
Regulatory Authority
Member: Mr. Ahmed Alqarni
Director of Reporting and Crisis Management
Surveillance and Biometrics,
Saudi FDA
Saudi Arabia
Regulatory Authority
Member: Ms. Laleetha DEVI
Asia Pacific RAQA Director
Kimberly Clark
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
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. Jocelyn YEN
RA/QA Manager, South East Asia
Bard Singapore Pte Ltd
Singapore

Industry

Member: Ms. Jackeline CHAN
Regulatory Affairs Manager
Elanco Animal Health
Hong Kong SAR, China
Industry
Member: Ms. Lois YEUNG
Senior Regulatory Affairs & Compliance Specialist
Becton Dinkinson Asia 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 and Quality Manager
Draeger Medical Sourth East Asia Pte Ltd
Singapore
Industry
Member: Dr. Sompob Paibulsirijit
Regional Safety officer, Asia Pacific
Johnson & Johnson Thailand Ltd
Thailand
Industry
Member: Ms. Chueh-pin CHEN
Team Leader of Division of Drug Safety
Taiwan Drug Relief Foundation/ Taiwan National ADR Reporting Center
Chinese Taipei


 

WG4 Documents

 

1. AHWP/WG4/F001:2014

Title: Adverse Event Reporting Timelines Guidance for Medical Device Manufacturer and its Authorised Representative

Date: 21 Nov 2014

Download file:Final_AHWP_WG4_F001_2014.pdf

 

2. AHWP/WG2/F001:2013 (now restructured to WG4)

Title: Adverse Event Reporting Guidance for the Medical Device Manufacturer or its Authorized Representative

Date: 6 Dec 2013

Download file:Final_AHWP_WG2_F001_2013.pdf

 

3. AHWP/WG2/F002:2012 (now restructured to WG4)

Title: Medical Device Adverse Event (AE) Report Form

Date: 20 Nov 2012

Download file:AHWP-WG2-PMS-002_FINAL.pdf

 

4. AHWP/WG2/F002:2012 (now restructured to WG4)

Title: Definition and Classification of Field Corrective Actions, including Field Safety Corrective Actions, Recalls and Non Safety related Field Corrective Actions

Date: 20 Nov 2012

Download file:AHWP-WG2-PMS-003_FINAL.pdf