Technical Committee - TC Representatives from Member Countries/ Regions

TC Office bearers
TC Representatives from Member Countries/ Regions

TC Representatives from Member Countries/ Regions:

Brunei Darussalam	Regulatory Authority (primary representative)	Mr. Mohd Asni ABD GHANI Senior Biomedical Engineer Medical Device Regulatory Section Healthcare Technology Department Ministry of Health Brunei Darussalam
	Regulatory Authority (secondary representative)	Mr. Mohd Fa'izun HASNAN Biomedical Engineer Medical Device Regulatory Section Healthcare Technology Department Ministry of Health Brunei Darussalam
	Industry (primary representative)	Nil
	Industry (secondary representative)	Nil
Cambodia	Regulatory Authority (primary representative)	Mrs. Nouv Phalla Deputy Chief (Registration Bureau) Department of Drugs and Food Ministry of Health Cambodia
	Regulatory Authority (secondary representative)	Ms. Lim Phany Deputy Chief (Registration Bureau) Department of Drugs and Food Ministry of Health Cambodia
	Industry (primary representative)	Nil
	Industry (secondary representative)	Nil
Chile	Regulatory Authority (primary representative)	Ms. Catalina VALDES Professional Medical Devices Office Public Health Institute of Chile Chile
	Regulatory Authority (secondary representative)	Ms. Maria Graciela ROJAS Head Medical Devices Office Public Health Institute of Chile Chile
	Industry (primary representative)	Ms Jacqueline CASTRO Secretary Medical Devices Society Chile
	Industry (secondary representative)	Mr Sergio ROJAS Treasurer Medical Devices Society Chile
Chinese Taipei	Regulatory Authority (primary representative)	Ms. Cheng-Ning WU Senior Technical Specialist Division of Medical Devices and Cosmetics Food and Drug Administration Ministry of Health and Welfare Chinese Taipei
	Regulatory Authority (secondary representative)	Mr. Wen-Wei TSAI Section Chief Division of Medical Devices and Cosmetics Food and Drug Administration Ministry of Health and Welfare Chinese Taipei
	Industry (primary representative)	Ms. Emily Chiang Corporate Affairs & VBHC Director, Taiwan and Hong Kong Medtronic (Taiwan) Ltd. Chinese Taipei
	Industry (secondary representative)	Ms. Angela HSU Professional Affairs & Corporate Communication Director Johnson & Johnson Medcial Taiwan Ltd.
Hong Kong SAR, China	Regulatory Authority (primary representative)	Mr. Yorkie CHOW Medical Device Division Department of Health Hong Kong SAR Government
	Regulatory Authority (secondary representative)	Mr. Alex CHOI Senior Electronics Engineer (Medical Device)2 Department of Health Hong Kong SAR Government
	Industry (primary representative)	Nil
	Industry (secondary representative)	Mr. Jack WONG RAQA Senior Director APAC, CooperVision
India	Regulatory Authority (primary representative)	Dr V. G. Somani Joint Drug Controller Central Drugs Standard Control Organization DGHS MOH &FW, FDA
	Regulatory Authority (secondary representative)	Mr. Somnath Basu Assistant Drugs Controller Central Drugs Standard Control Organization DGHS, MOH & FW, FDA Bhawan India
	Industry (primary representative)	Sudhakar Mairpadi Director Quality Regulatory & Govt Affairs Philips, India
	Industry (secondary representative)	Veena Kohli CEO, Vanguard Diagnostics, India
Indonesia	Regulatory Authority (primary representative)	Ms. Nazmi Senior Reviewer of Medical Device Ministry of Health Indonesia
	Regulatory Authority (secondary representative)	Nil
	Industry (primary representative)	Dr. Cristina Sandjaja Secretary General ASPAKI
	Industry (secondary representative)	Ms. Sandra Arsani Head of Export, Investment and International Affairs ASPAKI
Japan	Regulatory Authority (primary representative)	MIYASAKA Tomoyuki Deputy Director Medical Devices Evaluation Division Ministry of Health, Labour and Welfare (MHLW)
	Regulatory Authority (secondary representative)	MURAKAMI Madoka Principal Reviewer Office of Software as a Medical Devices Pharmaceuticals and Medical Devices Agency (PMDA)
	Industry (primary representative)	YANAGIDA Yuji Internaional Policy & Strategy Committee Chair Japan Federation of Medical Devices Association (JFMDA)
	Industry (secondary representative)	ASAI Hideki ISO/TC 210 Domestic Committee Vice Chair Japan Federation of Medical Devices Association (JFMDA)
Jordan	Regulatory Authority (primary representative)	Dr. Shatha Al-Quraan Head of Medical Device & Equipment Dept. Jordan Food and Drug Administration
	Regulatory Authority (secondary representative)	Nil
	Industry (primary representative)	Dr. Mohammed Saleem Science-forum (SIPS) Amman- Jordan
	Industry (secondary representative)	Nil
Kazakhstan	Regulatory Authority (primary representative)	Mrs. Gulnar Berkimbayeva Head of medical device primary expertise department National Center for Expertise Kazakhstan
	Regulatory Authority (secondary representative)	Mrs. Diana Arys Senior specialist of medical device testing laboratory National Center for Expertise Kazakhstan
	Industry (primary representative)	Nil
	Industry (secondary representative)	Nil
Kingdom of Bahrain	Regulatory Authority (primary representative)	Nil
	Regulatory Authority (secondary representative)	Nil
	Industry (primary representative)	Nil
	Industry (secondary representative)	Nil
Kingdom of Saudi Arabia	Regulatory Authority (primary representative)	Mr. Ali M. AL-DALAAN Vice Executive President Medical Devices Sector Saudi Food & Drug Authority Kingdom of Saudi Arabia
	Regulatory Authority (secondary representative)	Dr. Abdullah Alwatban Executive Director Saudi Food & Drug Authority Kingdom of Saudi Arabia
	Industry (primary representative)	Mr. Fahad Al Moammar GM Damad
	Industry (secondary representative)	Mr. Faisal Mansour Matbuli Sr. RA Director medtronic
Kyrgyz Republic	Regulatory Authority (primary representative)	Mrs. Ainura Abalieva Head of Registration Medical Devices Department Kyrgyz Republic
	Regulatory Authority (secondary representative)	Ms. Aikerim Sharypova Specialist of Registration Medical Devices Department Kyrgyz Republic
	Industry (primary representative)	Nil
	Industry (secondary representative)	Nil
Laos PDR	Regulatory Authority (primary representative)	Ms. Davone Douangdany Chief of Drug and Medical Device Control Division Food and Drug Department Ministry of Health Laos PDR
	Regulatory Authority (secondary representative)	Ms. Khampheng Trengbiacheu Deputy Chief of Drug and Medical Device Control Division Food and Drug Department Ministry of Health Laos PDR
	Industry (primary representative)	Mr Alfred Kwek Senior Director Edwards Lifesciences
	Industry (secondary representative)	Nil
Malaysia	Regulatory Authority (primary representative)	Salbiah BT Yaakop Director of Policy, International Affairs & Industry Facilitation Division Medical Device Authority Ministry of Health Malaysia
	Regulatory Authority (secondary representative)	Aidahwaty M. Olaybal Principal Assistant Director Medical Device Authority Ministry of Health Malaysia
	Industry (primary representative)	Ong Yean Ting Malaysia
	Industry (secondary representative)	Tony LOW BS-P Medical Non-radiation Device & Technology TUV Rheiland Malaysia
Mongolia	Regulatory Authority (primary representative)	Nil
	Regulatory Authority (secondary representative)	Nil
	Industry (primary representative)	Nil
	Industry (secondary representative)	Nil
Myanmar	Regulatory Authority (primary representative)	Nil
	Regulatory Authority (secondary representative)	Nil
	Industry (primary representative)	Nil
	Industry (secondary representative)	Nil
Pakistan	Regulatory Authority (primary representative)	Dr. Sheikh Akhter Hussain Director Medical Device Division Drug Regulatory Authority of Pakistan Pakistan
	Regulatory Authority (secondary representative)	Asif Jalil Assistant Drugs Controller (Medical Devices) Drug Regulatory Authority of Pakistan Pakistan
	Industry (primary representative)	Nadeem Hussain Alamgir CEO/Director RA Consultants (SMC-PVT) Limited Pakistan
	Industry (secondary representative)	Nil
People's Republic of China	Regulatory Authority (primary representative)	Gao Guobiao Secretary of Leading Party Group Center for Medical Device Evaluation NMPA People's Republic of China
	Regulatory Authority (secondary representative)	Li Jun Deputy Director General Department of Medical Device Regulation NMPA People's Republic of China
	Industry (primary representative)	Xiaofang Yang Deputy Secretary General China Association for Medical Devices Industry
	Industry (secondary representative)	Yuhong Amber Wang Vice President Regulatory Affairs & Quality Assurance Genesis Medteach Group
Philippines	Regulatory Authority (primary representative)	Maria Cecilia MATIENZO Division Chief Medical Non-Radiation Device Regulation Division Bureau of Health Devices & Technology Philippines
	Regulatory Authority (secondary representative)	Nil
	Industry (primary representative)	Rhoel Laderas Baxter Philippines Philippines
	Industry (secondary representative)	Michelle Mendador Alcon Labs. Philippines Philippines
Republic of Korea	Regulatory Authority (primary representative)	Dr. Jeong-Rim Lee Director General Medical Device Evaluation Division Ministry of Food and Drug Safety(MFDS) Republic of Korea
	Regulatory Authority (secondary representative)	Dr. Seil Park Assistant Director Cardiovascular and Imaging Devices Division Ministry of Food and Drug Safety(MFDS) Republic of Korea
	Industry (primary representative)	Ms. Eun-Hee Cho RA Director Abbott Medical Korea
	Industry (secondary representative)	Ms. Rachel H. Chung Managing Director for Medical Device Group 1 Synex Republic of Korea
Singapore	Regulatory Authority (primary representative)	Dr. Rama Sethuraman Director, Medical Devices Health Sciences Authority Singapore
	Regulatory Authority (secondary representative)	Ms. Liew Lai Ling Senior Regulatory Specialist Health Sciences Authority Singapore
	Industry (primary representative)	Mr. Terry Song Kuok Hui Head of Quality & Regulatory Affairs ASEAN Boston Scientific Asia Pacific Pte.Ltd. Singapore
	Industry (secondary representative)	Ms Grace SUN RA/QA Manager KaVo Dental Asia Pacific Pte Ltd. Singapore
South Africa	Regulatory Authority (primary representative)	Mrs. Portia Nkambule Chief Regulatory Officer South African Health Products Regulatory Authority South Africa
	Regulatory Authority (secondary representative)	Dr. Dimakatso Mathibe Senior Manager Medical Device and Radiation Control South African Health Products Regulatory Authority South Africa
	Industry (primary representative)	Ms. Tanya Vogt Chief Operating Officer South African Medical Device Industry Association (SAMED) South Africa
	Industry (secondary representative)	Ms. Madeleine PEARCE Chair of the Regulatory Committee SAMED & SALDA South Africa
State of Kuwait	Regulatory Authority (primary representative)	Adel A. Alhajji Ministry of health Biomedical Engineering Administration State of Kuwait
	Regulatory Authority (secondary representative)	Nil
	Industry (primary representative)	Nil
	Industry (secondary representative)	Nil
Sultanate of Oman	Regulatory Authority (primary representative)	Eng. Faiza Al Zadjali
	Regulatory Authority (secondary representative)	Hamed Saleh Al. Rashdi
	Industry (primary representative)	Nil
	Industry (secondary representative)	Nil
Thailand	Regulatory Authority (primary representative)	Mr. Varavoot Sermsinsiri Director Medical Device Control Division Food and Drug Administration
	Regulatory Authority (secondary representative)	Mr. Nakorn TANGWANCHAREANCHAI Post-market control supervisor Medical Devices Control Division Food and Drug Administration
	Industry (primary representative)	Ms. Chadaporn TANAKASEMSUB (Miang) Head of Regulatory Affairs (RA) Asia Pacific (AP) Johnson & Johnson Vision
	Industry (secondary representative)	Mr. Prompong Ukkakimapan
Tanzania	Regulatory Authority (primary representative)	Ms. Rehema Forgen Mariki Manager, Medical Devices and Diagnostics Assessment Tanzania Medicines and Medical Devices Authority (TMDA)
	Regulatory Authority (secondary representative)	Mr. Bryceson Paul Kibasa Manager, Medical Devices Licensing Tanzania Medicines and Medical Devices Authority (TMDA)
	Industry (primary representative)	Nil
	Industry (secondary representative)	Nil
United Arab Emirates	Regulatory Authority (primary representative)	Dr Amal Al Awadhi
	Regulatory Authority (secondary representative)	Nil
	Industry (primary representative)	Mounir Haddad
	Industry (secondary representative)	Nil
United States of America	Regulatory Authority (primary representative)	Kenneth Cavanaugh Deputy Director Office of Cardiovascular Devices US FDA Center for Devices and Radiological Health
	Regulatory Authority (secondary representative)	Melissa Torres Associate Director for International Affairs US FDA Center for Devices and Radiological Health
	Industry (primary representative)	Nicole Taylor Smith VP Global Regulatory Policy Medtronic
	Industry (secondary representative)	Diane Wurzburger Executive Regulatory Affairs and Global Regulatory Policy GE Healthcare
Vietnam	Regulatory Authority (primary representative)	Nguyen Tu Hieu Expert Department of Medical Equipment & Construction Ministry of Health Vietnam
	Regulatory Authority (secondary representative)	Doan Quang Minh Expert Department of Medical Equipment & Construction Ministry of Health Vietnam
	Industry (primary representative)	Nguyen Thi Thu Thuy Johson & Johson Vietnam
	Industry (secondary representative)	Cao Thi Ai Lien Philips Vietnam
Yemen	Regulatory Authority (primary representative)	Nil
	Regulatory Authority (secondary representative)	Nil
	Industry (primary representative)	Nil
	Industry (secondary representative)	Nil
Zimbabwe	Regulatory Authority (primary representative)	Mr R. Rukwata
	Regulatory Authority (secondary representative)	MS G.N. Mahlangu
	Industry (primary representative)	Nil
	Industry (secondary representative)	Nil