Chair: |
Mr. Wen-wei TSAI |
Regulatory Authority |
Co-Chair: |
Ir. Prof. Albert K.F. POON |
Industry |
Advisor: | Ms. Shelley TANG Stellar Consulting Australia |
Industry |
WG Secretary | Mr. Christopher CHAN Senior Engineer Office of Medical Device Evaluation Center for Measurement Standards Industrial Technology Research Institute Chinese Taipei |
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. Marriamah Krishnasamy Principal Assistant Director Medical Device Bureau 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 Senior Medical Devices & Diagnostics Registration Officer Tanzania Food and Drugs Authority Tanzania |
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. 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: |
Ms. Samara ZHU |
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 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: |
Mr. Christopher CHAN |
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 |
Guidance Documents:
FINAL_GHTF SG1 Definition of the Terms
FINAL_03_AHWP-WG2-WD003-2016 IVD Submission Dossier__20160912
FINAL_02_AHWP-WG2-WD002-2016 CA for IVD_ 20160912
FINAL_01_AHWP-WG2-WD001-2016 IVD classification_20160912
Work Plan and Target:
AHWP_TC_WG1a_Work Plan 2012-2014
Comments
Testing
Testing 2