Technical Committee - TC Representatives from Member Countries/ Regions

TC Office bearers
TC Representatives from Member Countries/ Regions

TC Representatives from Member Countries/ Regions:

Botswana	Regulator Authority (primary representative)	Nil
	Regulator Authority (primary representative)	Nil
	Regulator Authority (secondary representative)	Nil
	Industry (primary representative)	Nil
	Industry (secondary representative)	Nil
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.
Cuba	Regulatory Authority (primary representative)	Yamila Cedeño Valdés Head of Medical Devices Evaluation Section CECMED
	Regulatory Authority (secondary representative)	Liena Nuñez Nuñez Head of IVDs Evaluation Section CECMED
	Industry (primary representative)	Ariel Palenzuela Díaz Quality Manager CIE
	Industry (secondary representative)	Dayanet Guillama Pino Head of the Comprehensive Quality Management Department CNEURO
Egypt	Regulatory Authority (primary representative)	Rania Soliman General manager of general administration of medical devices Marketing authorization Egyptian Drug Authority
	Regulatory Authority (secondary representative)	Noha Osama Elhariry General manager of general administration of medical devices Marketing authorization Egyptian Drug Authority
	Industry (primary representative)	Amr Elshafi Compliance manager Roche Diagnostics Egypt
	Industry (secondary representative)	Heba Tork Regulatory and quality manager Roche Diagnostics Egypt
Ghana	Regulator Authority (primary representative)	Mr. Emmanuel Nkumah Director Food and Drugs Authority Ghana
	Regulator Authority (secondary representative)	Mr. Roland Sefakor Head of Department Food and Drugs Authority Ghana
	Industry (primary representative)	Nil
	Industry (secondary representative)	Nil
Hong Kong SAR, China	Regulatory Authority (primary representative)	Mr. Tommy Lam Senior Electronics Engineer Medical Device Division Department of Health Hong Kong SAR Government
	Regulatory Authority (secondary representative)	Mr. Karl Leung Senior Electronics Engineer Medical Device Division 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)	Yuanita Fitriani Medical Device Resilience Officer Ministry of Health Indonesia
	Regulatory Authority (secondary representative)	Nazmi Medical Device Reviewer Ministry of Health Indonesia
	Industry (primary representative)	Sandra Arsani Head of Export, Investment and International Affairs ASPAKI
	Industry (secondary representative)	Wirda Nelly Member in Regulation and Formulation Strategy of Gakeslab Indonesia
Japan	Regulatory Authority (primary representative)	UENO Yukina Deputy Director Medical Devices Evaluation Division Ministry of Health, Labour and Welfare (MHLW) Japan
	Regulatory Authority (secondary representative)	MURAKAMI Madoka Principal Reviewer Office of Software as a Medical Devices Pharmaceuticals and Medical Devices Agency (PMDA) Japan
	Industry (primary representative)	YANAGIDA Yuji International 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
Macao SAR, China	Regulator Authority (primary representative)	Mr. Chan Tak In Chief of Division of Chemical Medicines and Medical Devices) Pharmaceutical Administration Bureau (ISAF), Macao SAR Government
	Regulator Authority (secondary representative)	Ms. Huang Chi Cheng Senior Technician (Medical Devices Specialty), Division of Chemical Medicines and Medical Devices) Pharmaceutical Administration Bureau (ISAF), Macao SAR Government
	Industry (primary representative)	Nil
	Industry (secondary representative)	Nil
Malaysia	Regulatory Authority (primary representative)	Idamazura Bt Idris Harun Director of Policy & Strategic Planning Division Medical Device Authority Ministry of Health Malaysia
	Regulatory Authority (secondary representative)	Norlela Bt Hatta Antah Director of International and Industry Affairs Division Medical Device Authority Ministry of Health Malaysia
	Industry (primary representative)	Ong Yean Ting Head Quality and Regulatory Roche Diagnostics Malaysia Sdn Bhd Malaysia
	Industry (secondary representative)	Tony LOW Director of Human Performance and Medical QA/RA Commissioning Agents International (CAI) 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 Kenya	Regulatory Authority (primary representative)	Fred M SIYOI Registrar Pharmacy and Poisons Board Ministry of Health Republic of Kenya
	Regulatory Authority (secondary representative)	Paulyne Wairimu Head of Medical Devices Pharmacy and Poisons Board Ministry of Health Republic of Kenya
	Industry (primary representative)	Nil
	Industry (secondary representative)	Nil
Republic of Korea	Regulatory Authority (primary representative)	Dr. Seong Hong-mo Director 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 Head of RAQA CONMED Korea Ltd. 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. Sharad Shukla Director Regulatory Affairs, MedTach Johnson & Johnson
	Industry (secondary representative)	Ms Grace SUN RA/QA Manager KaVo Dental Asia Pacific Pte Ltd. Singapore
South Africa	Regulatory Authority (primary representative)	Dr. Dimakatso Mathibe Senior Manager Medical Device and Radiation Control South African Health Products Regulatory Authority South Africa
	Regulatory Authority (secondary representative)	Ms. Lydia Motlogelwa Manager Medical Devices Registration and Clinical Trial South African Health Products Regulatory Authority South Africa
	Industry (primary representative)	Ms. Alwi Spearpoint Compliance & Regulatory Manager 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 Ministry of Health Sultanate of Oman
	Regulatory Authority (secondary representative)	Hamed Saleh Al. Rashdi
	Industry (primary representative)	Nil
	Industry (secondary representative)	Nil
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
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
United Arab Emirates	Regulatory Authority (primary representative)	Dr Amal Al Awadhi Director Drug Department Ministry of Health & Prevention
	Regulatory Authority (secondary representative)	Nil
	Industry (primary representative)	Mr. Mounir Haddad General Manager Abu Dhabi Medical Device Company
	Industry (secondary representative)	Nil
Uzbekistan	Regulator Authority (primary representative)	Nil
	Regulator Authority (secondary representative)	Nil
	Industry (primary representative)	Nil
	Industry (secondary representative)	Nil
Vietnam	Regulatory Authority (primary representative)	Nguyen Tu Hieu Vice Director Department of Medical Devices and Construction Ministry of Health Vietnam
	Regulatory Authority (secondary representative)	Doan Quang Minh Senior Specialist Department of Medical Devices and 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 Head Licensing and Enforcement Division Medicines Control Authority of Zimbabwe
	Regulatory Authority (secondary representative)	MS G.N. Mahlangu
	Industry (primary representative)	Nil
	Industry (secondary representative)	Nil