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

Updated: Thu, 12/14/2017 - 19:23

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
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 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:	Mrs. Nutchnat KITIWOURANON Senior Pharmacist Medical Device Control Division Food and Drug Administration Ministry of Public Health Thailand	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:	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:	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:	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:	Ms. Samara ZHU Medical Affairs Director of China & Regulatory 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 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 Senior Engineer Office of Medical Device Evaluation Center for Measurement Standards 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

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