Work Group 2 (WG2) - Pre-market: IVDD

Chair:

Mr. Wen-wei TSAI
Technical Specialist
Division of Medical Devices and Cosmetics
Food and Drug Administration
Department of Health
Chinese Taipei

Regulatory Authority
Co-Chair:

Ir Prof. Albert KF POON
Professor of Practice (Biomedical Engineering)
Interdisciplinary Division of BME
Hong Kong Polytechnic University
Hung Hom, Hong Kong

 Industry
Advisor: Ms. Shelley TANG
Stellar Consulting
Australia
 Industry
Advisor: Ms. Nancy SHADEED
Manager,(GHTF SG1, Chair)
Health Canada, Device Licensing Division
Medical Devices Bureau
Canada
Industry
Member: Ms. Maria Cecilia MATIENZO
Division Chief
Center for Device Regulation, Radiation Health
and Research - Food and Drug Administration
Department of Health
Philippines
Regulatory Authority
Member: Ms. Marriamah Krishnasamy
Senior Asst Director
Medical Device Bureau
Ministry of Health
Malaysia
Regulatory Authority
Member: Ms. Fan-Yin LIU
Associate Reviewer
Division of Medical Devices and Cosmetics
Food and Drug Administration
Department of Health
Chinese Taipei
Regulatory Authority
Member: Ms. CHEN Yu-Hua
Division of Medical Devices & Cosmetics
Food & Drug Administration
Ministry of Health & Welfare, Taiwan (R.O.C.)
Chinese Taipei
Regulatory Authority
Member: Mrs. Akua Owusua AMARTEY
Ag. Deputy Chief Executive
Medical Devices
Cosmetics & Household Chemicals, FDA Ghana
Regulatory Authority
Member: Miss Engerasia Thomas MTUI
Medical Devices & Diagnostics Registration Officer
Tanzania Food and Drugs Authority
Tanzania 
Regulatory Authority
Member: Ms Rehema Forgen MARIKI
Senior Medical Devices & Diagnostics Registration Officer
Tanzania Food and Drugs Authority
Tanzania
Regulatory Authority
Member:

Dr. Paulyne Wairimu KAMAU
Head of Medical devices and Diagnosics
Pharmacy and Poisons Board
State of Kenya

Regulatory Authority
Member: Dr. Cheryl McRAE
Branchy Head
Devices Authorization Branch
Therapeutic Goods Administration
Department of Health
Australia
Regulatory Authority
Member: Ms. NUNING LESTIN BINTARI
Head Section of Diagnostic Products
Directorate of Medical Device and Health Household Evaluation
Directorate General of Pharmaceuticals and Medical Device
Ministry of Health
the Republic of Indonesia
Regulatory Authority
Member: Dr Yong Kyoung LEE
Assistant Director
Ministry of Food and Drug Safety
National Institute of Food and Drug Safety Evaluation
Department of Me
Republic of Korea
Regulatory Authority
Member:  Ms Gulnar Berkimbayeva
Head
Department of Primary Expertise of Medical Devices
National Center of Expertise of Medicines and Medical Device
Kazakhstan
Regulatory Authority
Member:

Dr. Jane SC TSAI
SVP, YFY Biotech Management Company
Senior Advisor,Industrial Technology Research Institute
Chinese Taipei

Industry
Member: Ms Lisa YANG
Consultant, Regulatory Affairs
PharmEng Technology Pte.Ltd
Singapore
Industry
Member:

Mr. Sanoj PRABHAKARAN 
Regulatory Affairs Manger
Becton Dickinson, Middle East
Saudi Arabia

Industry
Member: Dr. Cristina SANDJAJA
General Manager
Prodia Diagnostic Line, PT
Jakarta
Industry
Member:

Ms. Sheryl HSIAO
Regulatory Affairs and Compliance Manager
BD Taiwan
Chinese Taipei

Industry
Member: Dr. Veronica WONG
Regulatory Affairs Officer
Sanwa Bio Tech Limited
Hong Kong
Industry
Member:

Ms. Samara ZHU
Medical Affairs Director of China & Regulatory Affairs Director of Distribution
Asia, Alere
People's Republic of China

Industry
Member: Mr. Daniel CHANG
Product & Regulatory Director
Giraffes Pharmaceutical., Ltd
Chinese Taipei
Industry
Member: Mr. Derek LEE
Quality Assurance Officer
Sanwa BioTech Limited
Hong Kong
Industry
Member: Ms. Hailey CHU
IVD Technical Specialist
British Standards Institution (BSI)
Chinese Taipei
Industry
Member: Ms. Sandra CHU
Senior Medical Regulatory Affairs Manager
Roche Diagnostics Ltd.
Chinese Taipei
Industry
Member: Ms. Loo Hui Ying
Regulatory Affairs and Operations Assistant Manager
INEX Innovations Exchange Pte Ltd
Singapore
Industry
Member: Dr. Schneider Adelheid
Regional Regulatory Affairs & Quality Manager Asia Pacific
Roche Diagnostics Asia Pacific Pte Ltd
Singapore
Industry
Member: Mr. Christopher CHAN
Industrial Technology Research Institute
Chinese Taipei
Industry
Member: Ms Stella FANN
Senior Engineer
Office of Medical Device Evaluation
Center for Measurement Standards
Industrial Technology Research Institute
Chinese Taipei
Industry
Member: Ms Jina YOO
Manager
Samsung Electronics
Republic of Korea
Industry
Member: Dr YoungSook PARK
RAQA/Blood Bank Director
Diagnostics Division
Abbott Korea Ltd.
Republic of Korea
Industry
Member: Mr Jongwon KIM
R&D Director
Labgenomics Co
Republic of Korea
Industry


 

WG2 Documents

1.  AHWP/WG2/F001:2014

Title: Comparison between CSDT and STED IVDDs

Date: 21 Nov 2014

Download file:Final_AHWP_WG2_F001_2014.pdf

 

2. AHWP/WG2-WG8/F002:2014

Title: Role of Standards in the Assessment of Medical Devices

Date: 21 Nov 2014

  Download file:Final_AHWP_WG2_WG8_F002_2014.pdf

 

3. AHWP/WG1a/F004:2013 (now restructured to WG2)

Title: Comparison between the GHTF Summary Technical Documentation (STED) formats for Medical Devices and In Vitro Diagnostic Medical Devices and the Common Submission Dossier Template (CSDT) format

Date: 6 Dec 2013

Download file:Final_AHWP_WG1a_F004_2013.pdf

 

4. AHWP/WG1a/F002:2013 (now restructured to WG2)

Title: Essential Principles of Safety and Performance of IVD Medical Devices

Date: 6 Dec 2013

Download file:Final_AHWP_WG1a F002_2013.pdf

 

5. AHWP/WG1a/F001:2013 (now restructured to WG2)

Title: AHWP Regulatory Framework for IVD Medical Devices

Date: 6 Dec 2013

Download file:Final_AHWP_WG1a F001_2013.pdf