| Chair: |
Dr. Wen-wei TSAI Email: tww@fda.gov.tw |
Regulatory Authority |
| Co-Chair: |
Dr. Adelheid Schneider 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 |
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: | Mr. Shifu GUO Associate Director, Division III of Standardization Administration, National Institutes for Food and Drug Control (NIFDC) People's Republic of China |
Regulatory Authority |
| Member: | Dr. Sangjin PARK Scientific Officer/ Assistant Director, Ministry of Food & Drug Safety Republic of Korea |
Regulatory Authority |
| Member: | Dr. Heba AHMED SADEK Manager of Administration of IVD Listing Unit Egyptian Drug Authority Egypt |
Regulatory Authority |
| Member: | Dr. Sara EMAD GUIRGUIS Manager of Imported IVD Listing Unit Egyptian Drug Authority Egypt |
Regulatory Authority |
| Member: |
Dr. Jane SC TSAI |
Industry |
| Member: |
Dr. Tzu Ling TSENG |
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 |
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 |
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 |
| Member: | Ms. Yani LINA Regulatory Affairs Manager Becton Dickinson Indonesia Indonesia |
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
Work Plan and Target:
GHWP_TC_WG1a_Work Plan 2012-2014