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

Dr. Wen-wei TSAI
Section Chief
Food and Drug Administration
Ministry of Health and Welfare
Chinese Taipei

Email: tww@fda.gov.tw 

Regulatory Authority
Co-Chair:

Dr. Adelheid Schneider
Regional Head of Quality and Regulatory Affairs
Roche Diagnostics Asia Pacific

Email: adelheid.schneider@roche.com

 Industry
Advisor: Ms. Shelley TANG
Stellar Consulting
Australia
 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: Dr. Adel ALMAWASH
Head
Section In-Vitro Diagnostic Devices Licensing
Saudi Food And Drug Authority
Kingdom of Saudi Arabia
Regulatory Authority
Member: Mr. Augusto GEYER
Manager
Office of In Vitro Diagnostics,
ANVISA-Ag encia Nacional de Vigilancia Sanitaria
(Brazilian Health Regulatory Agency)
Brazil
Regulatory Authority
Member: Mr. Abdullah THABIT
Director
International Relations for Medical Devices,
Saudi Food And Drug Authority
Kingdom of Saudi Arabia
Regulatory Authority
Member: Ms. Mariamah Krishnasamy
Principal Assistant Director
Medical Device Authority
Ministry of Health
Malaysia
Regulatory Authority
Member: Ms. Fan-Yin LIU
Reviewer
Division of Medical Devices and Cosmetics
Food and Drug Administration
Department of Health
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
Manager, Medical Devices and Diagnostics Assessment
Tanzania Medicines and Medical Devices Authority (TMDA)
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
Division of Vitro Diagnostic Devices
Medical Device Evaulation Department
National Institute of Food and Drug Safety Evaluation
Republic of Korea
Regulatory Authority
Member: Dr. Reba Chhabra
Deputry Director of Quality Control Diagnosticas
National Institute of Biologicals
Ministry of Health & Family Welfare
India
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: Mrs. Sirinmas KATCHAMART
Senior Pharmacist
Medical Device Control Division
Food and Drug Administration
Ministry of Public Health
Thailand
Regulatory Authority
Member: Ms. Linda NHUKARUME
Analyst
Medicines Control Authority
Zimbabwe
Regulatory Authority
Member: Dr. Akanksha BISHT
Scientist Grade II & Head
Immunodiagnostic Kit, Molecular Diagnostic, Blood Reagent & Covid-19 Kit Testing Laboratories
National Institute of Biologicals, MOH&FW,
Government of India
Regulatory Authority
Member: Dr. Shao-Hsuan CHANG
Regulatory Engineer
Office of Medical Device Evaluation
Industrial Technology Research Institute
Chinese Taipei
Regulatory Authority
Member: Dr. Sora LEE
Scientific officer
National Institute of Food and Drug Safety Evaluation
Republic of Korea
Regulatory Authority
Member: Mr. Shang-Ching LIN
Associate Technical Specialist
Taiwan Food and Drug Administration
Chinese Taipei
Regulatory Authority
Member: Ms. Amani Mohammed Mubarak Al Ghielani 
Biomedical Engineer, IVD Registration Head Section
Ministry of Health
Sultanate of Oman
Regulatory Authority
Member: Ms. ZhaoZhao HAN
Deputy Division Chief
Center for Medical Device Evaluation of NMPA
People's Republic of China
Regulatory Authority
Member:

Dr. Jane SC TSAI
Senior Vice President (SVP)
YFY Biotech Management Company
Chinese Taipei

Industry
Member:

Dr. Tzu Ling TSENG
Reviewer
Division of Medical Devices, Cneter of Drug Evaluation
Chinese Taipei

Industry
Member: Mr. Johnny Chan
Global Director
Organizational & Business Excellence,
Danfoss A/S, Danmark
Hong Kong SAR, China
Industry
Member: Mr. Jinyao SU
Manager
ETPL/Diagnostic Development Hub
Singapore
Industry
Member: Ms. Jacqueline C. MONTEIRO
Associate Director, APAC
Abbott Laboratories
Singapore
Industry
Member: Dr. Adelheid Ingrid Schneid
Head of Regulatory Affairs APAC
Roche Diagnostics Asia Pacific
Singapore
Industry
Member: Ms Lisa YANG
Senior Consultant
PharmEng Technology Pte.Ltd
Singapore
Industry
Member: Ms. Judy CHEUNG Yin Yee
QRA Manager
Mirxes 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: Dr. Paul CHEUNG Kin Fai
Scientist & Production Manager
DiagCor Bioscience Incorporation Limited
Hong Kong SAR, China
Industry
Member:

Ms. Sheryl HSIAO
Asia RAQC Leader
3M HCBG
Singapore

Industry
Member: Dr. Veronica WONG
Regulatory Affairs Officer
Sanwa Bio Tech Limited
Hong Kong
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
Regulatory Lead
British Standard Institution (BSI)
Chinese Taipei
Industry
Member: Ms. Sandra CHU
Senior Manager
Medical Regulatory Affairs
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: 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: Ms. Lynn TSENG
Senior Manager
Regulatory Affairs & Quality Assurance – North Asia
Hologic Asia Pacific Ltd.
Chinese Taipei
Industry
Member: Ms. Karinis CHU
Senior RA & QA Specialist
Werfen Hong Kong Limited
Hong Kong SAR, China
Industry
Member: Dr. Henry HOU
Regional Head of Regulatory Affairs and Quality Assurance
Elekta Limited
Hong Kong SAR, China
Industry
Member: Ms. Ning Zhen Justina LEE
Senior Regulatory Affairs Specialist- APAC
The Binding Site
Singapore
Industry
Member: Ms. Yon Ju KANG
Sr. Global Regulatory Affairs Manager
Johnson & Johnson
Republic of Korea
Industry
Member: Ms. Asmaa AWAD
Global Regulatory Policy Lead EE, ME& Africa
Roche Diagnostics
Dubai, United Arab Emirates
Industry
Member: Dr. Shimbu TOMIMURA
Director, Quality Assurance & Regulatory Affairs Department
A&T Corporation
Japan
Industry
Member: Mr. Koji SEKIGUCHI
RA Manager
QIAGEN K.K.
Japan
Industry
Member: Mr. Xinbing WANG
Regulatory Director
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
People's Republic of China
Industry

 


Guidance Documents: 

FINAL_GHTF SG1 Definition of the Terms

FINAL_03_GHWP-WG2-WD003-2016 IVD Submission Dossier__20160912

FINAL_02_GHWP-WG2-WD002-2016 CA for IVD_ 20160912

FINAL_01_GHWP-WG2-WD001-2016 IVD classification_20160912

Final_GHWP_WG1a_F004_2013

Final_GHWP_WG1a_F002_2013

Final_GHWP_WG1a_F001_2013


Work Plan and Target: 

GHWP_TC_WG1a_Work Plan 2012-2014