Members | GHWP

GHWP Chair : Dr. Xu Jinghe, Deputy Commissioner, National Medical Products Administration (NMPA), People's Republic of China

GHWP Vice-Chair (Regulatory Authority): Mr. Lupi Trilaksono, Team Lead, Medical Device Local Content & Production Improvement, Ministry of Health, Indonesia

GHWP Vice-Chair (Industry): Ms. EunHee Cho, RA Director, Abbott Medical Korea, Republic of Korea


Brunei Darussalam	Regulatory Authority (primary representative)	Ms. Ruby HJ HARUN Acting Director Healthcare Technology Department Ministry of Health Brunei Darussalam
	Regulatory Authority (secondary representative)	Mr. Mohd Asni ABD GHANI Senior Biomedical Engineer 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. Maria Cecilia LOPEZ Professional Medical Devices Office Public Health Institute of Chile Chile
	Regulatory Authority (secondary representative)	Ms. Ana Maria CONCHA Professional Medical Devices Office Public Health Institute of Chile Chile
	Industry (primary representative)	Mr. Esteban GONZALEZ President Medical Devices Society Chile
	Industry (secondary representative)	Mr. Luis PIZARRO Vice President Medical Devices Society Chile
Chinese Taipei	Regulatory Authority (primary representative)	Ms. Pei-Weng TU Director Division of Medical Devices and Cosmetics Food and Drug Administration Ministry of Health and Welfare Chinese Taipei
	Regulatory Authority (secondary representative)	Dr. Chia-Hung CHIEN Deputy Director Division of Medical Devices and Cosmetics Food and Drug Administration Ministry of Health and Welfare Chinese Taipei
	Industry (primary representative)	Mr. Teeming TSAO Chief Executive Officer Coreleader Biotech. Co. LTD.
	Industry (secondary representative)	Mr. Albert T.W. LI Manager, Office of Medical Device Evaluation, Center for Measurement Standards Industrial Technology Research Institute
Hong Kong SAR, China	Regulatory Authority (primary representative)	Dr. Joanna SO Principal Medical & Health Officer (Medical Device) Department of Health Hong Kong SAR Government
	Regulatory Authority (secondary representative)	Dr. Ambrose WONG Senior Medical & Health Officer (Medical Device) Department of Health Hong Kong SAR Government
	Industry (primary representative)	Mr. Jack WONG Head of Regulatory Affairs, International RegASK
	Industry (secondary representative)	Nil
India	Regulatory Authority (primary representative)	Dr V. G. Somani Joint Drugs Controller Central Drugs Standard Control Organisation DGHS, MOH & FW, FDA India
	Regulatory Authority (secondary representative)	Dr. Ravi Kant Sharma Assistant Drugs Controller Central Drugs Standard Control Organisation DGHS, MOH & FW, FDA India
	Industry (primary representative)	Ms Sumati Randeo Director Government Affairs Danaher Corporation India
	Industry (secondary representative)	Vibhav Garg VP Health Policy & Govt. Affairs, GE India India
Indonesia	Regulatory Authority (primary representative)	Mr. Lupi Trilaksono Team Lead, Medical Device Local Content & Production Improvement Ministry of Health of the Republic of Indonesia
	Regulatory Authority (secondary representative)	Mr. Fikriansyah Medical Device Reviewer Ministry of Health of the Republic of Indonesia
	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)	TAKAHATA Masahiro Deputy Director Medical Devices Evaluation Division Ministry of Health, Labour and Welfare (MHLW)
	Regulatory Authority (secondary representative)	KUSAKABE Tetsuya International Coordination Officer Pharmaceuticals and Medical Devices Agency (PMDA)
	Industry (primary representative)	YANAGIDA Yuji Internaitonal 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)	Dr. Saleem Al Mahrouq Medical Device & Equipment Director Jordan Food and Drug Administration
	Industry (primary representative)	Dr. Mohammed Saleem Science-forum (SIPS) Amman-Jordan
	Industry (secondary representative)	Nil
Kazakhstan	Regulatory Authority (primary representative)	Mrs Akmaral Kabdenova Deputy General Director National Center for Drugs and Medical Devices Expertise Kazakhstan
	Regulatory Authority (secondary representative)	Mr. Olzhas Akhmetsadyk Head 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)	Mr Nada AI SAYEGH Consultant/ engineering safety National Healthcare Regulatory Authority Kingdom of Bahrain
	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)	Mr. Abdullah AI Rasheed Consultant 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)	Dr. Gulmira Shakirova General Director Department of Drug Provision and Medical Equipment Ministry of Health Kyrgyz Republic
	Regulatory Authority (secondary representative)	Мrs. Аinurа Abalieva Head of Registration Medical Devices Department Kyrgyz Republic
	Industry (primary representative)	Nil
	Industry (secondary representative)	Nil
Laos PDR	Regulatory Authority (primary representative)	Mr. Bounxou KEOHAVONG Director General Food and Drug Department Ministry of Health Laos PDR
	Regulatory Authority (secondary representative)	Ms. Davone Douangdany Chief of Drug and Medical Device Control Division Food and Drug Department Ministry of Health Laos PDR
	Industry (primary representative)	Ms. Quan TRAN Vice President Quality Assurance and Regulatory Affairs Baxter Healthcare
	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)	Norhafizah Binti Mohd Salleh Principal Assistant Director Medical Device Authority Ministry of Health Malaysia
	Industry (primary representative)	Ong Yean Ting Malaysia
	Industry (secondary representative)	Tony LOW Director of QA/RA and Human Performance Commissioning Agents International Malaysia
Mongolia	Regulatory Authority (primary representative)	Mr Bayarjargal. S Senior Biomedical Engineer Mongolian Regulatory Agency of Standardisation and Metrology Mongolia
	Regulatory Authority (secondary representative)	Mr Ganbaatar. Ts Officer Policy Planning on Health Technology Ministry of Health and Sports Mongolia
	Industry (primary representative)	Mr Enkhjargal. B Professor Biomedical Engineering Department Mongolian University of Science and Technology Mongolia
	Industry (secondary representative)	Nil
Myanmar	Regulatory Authority (primary representative)	Dr Myint SEIN Deputy Director General Myanmar Pharmaceutical Factory Myanmar
	Regulatory Authority (secondary representative)	Nil
	Industry (primary representative)	Nil
	Industry (secondary representative)	Nil
Pakistan	Regulatory Authority (primary representative)	Dr. Muhammad Fakhr ud Din Aamir Director, Medical Devices & Medicated Cosmetics Drug Regulatory Authority Pakistan
	Regulatory Authority (secondary representative)	Ms. Unum Zia Shamsi Assistant Director, Medical Devices & Medicated Cosmetics Drug Regulatory Authority Pakistan
	Industry (primary representative)	Nadeem Hussain Alamgir CEO/Director RA Consultants (SMC-PVT) Limited Pakistan
	Industry (secondary representative)	Muhammad Sohail Manager Regulatory Affairs Fresenius Medical Care Pakistan Private Ltd Pakistan
People's Republic of China	Regulatory Authority (primary representative)	Xu Jinghe Deputy Commissioner NMPA People's Republic of China
	Regulatory Authority (secondary representative)	Gao Guobiao Secretary of Leading Party Group Center for Medical Device Evaluation NMPA People's Republic of China
	Industry (primary representative)	Deyuan Jiang Senior Consultant China Association for Medical Device Industry
	Industry (secondary representative)	Hengkun Zhao Deputy General Manager Shandong Weigao Group Medical Polymer Co. Limited
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)	Johanna Gullle BD Philippines Philippines
	Industry (secondary representative)	Julie Anne Odarbe Allergan Healthcare Philippines
Republic of Kenya	Regulatory Authority (primary representative)	Mr. Fred M. SIYOI Registrar Pharmacy and Poisons Board Medical Device Safety Bureau Ministry of Health Republic of Kenya
	Regulatory Authority (secondary representative)	Dr. 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. Jeong-Rim Lee Director General Medical Device Evaluation Division Ministry of Food and Drug Safety(MFDS) Republic of Korea
	Regulatory Authority (secondary representative)	Dr. Hye-Won Roh 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 Republic of Korea
	Industry (secondary representative)	Ms. Rachel H. Chung Managing Director, Medical Device Group 1 Synex Consulting Ltd. Republic of Korea
Singapore	Regulatory Authority (primary representative)	Dr. Rama Sethuraman Director, Medical Devices Medical Devices Cluster Health Sciences Authority Singapore
	Regulatory Authority (secondary representative)	Ms Liew Lai Ling Assistant Director, Diagnostic Devices Branch Medical Devices Cluster Health Sciences Authority Singapore
	Industry (primary representative)	Ms. Jacqueline Cecilla Monteiro SMF MTIG 1st Deputy Chairman SMF MTIG, Singapore
	Industry (secondary representative)	Ms. Jocelyn Yen RA/QA Manager, SEA Bard Singapore Pte. Ltd., Singapore
South Africa	Regulatory Authority (primary representative)	Mr. Sam Bakhane Deputy Director General Health Technology National Department of Health South Africa
	Regulatory Authority (secondary representative)	Mr. Leon du Toit Deputy Director Radiation Control & Electromedical Devices Department of Health 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)	Dr. Mohammed Hamdan Al Rubaie Director General Pharmaceutical Affairs & Drug Control, Ministry of Health Sultanate of Oman
	Regulatory Authority (secondary representative)	Eng. Faiza Al Zadjali Ministry of Health Sultanate of Oman
	Industry (primary representative)	Nil
	Industry (secondary representative)	Nil
Tanzania	Regulatory Authority (Primary representative)	Mr. Adam Mitangu Fimbo Director General Tanzania Medicines and Medical Devices Authority (TMDA)
	Regulatory Authority (Secondary representative)	Ms. Kissa Watson Mwamwitwa Director of Medical Devices and Diagnostics Control Tanzania Medicines and Medical Devices Authority (TMDA)
	Industry (Primary repressentative)	Nil
	Industry (Secondary representative)	Nil
Thailand	Regulatory Authority (primary representative)	Mr. Varavoot Sermsinsiri Director Medical Device Control Division Food and Drug Administration Thailand
	Regulatory Authority (secondary representative)	Mr. Nakorn TANGWANCHAREANCHAI Post-market control supervisor Medical Devices Control Division Food and Drug Administration Thailand
	Industry (primary representative)	Ms. Mallika LATAVALYA NA AYUDHAYA Manager Thai Medical Device Technology Industry Association Thailand
	Industry (secondary representative)	Ms. Siriphan Eiamrungroj Thailand
United Arab Emirates	Regulatory Authority (primary representative)	Dr. Amal AI Awadhi Director of Drug Department Ministry of Health and Prevention United Arab Emirates
	Regulatory Authority (secondary representative)	Nil
	Industry (primary representative)	Mounir Haddad General Manager Abu Dhabi Medical Device Company Dubai, United Arab Emirates
	Industry (secondary representative)	Nil
United States of America	Regulatory Authority (primary representative)	Melissa Torres Associate Director for International Affairs US FDA Center for Devices and Radiological Health
	Regulatory Authority (secondary representative)	Michelle Noonan International Policy Analyst US FDA Center for Devices and Radiological Health
	Industry (primary representative)	Janet Trunzo Senior Advisor to the President Senior Executive Vice President Technology & Regulatory Affairs Advanced Medical Technology Association (AdvaMed)
	Industry (secondary representative)	Zach Rothstein Senior Vice President Technology & Regulatory Affairs Advanced Medical Technology Association (AdvaMed)
Vietnam	Regulatory Authority (primary representative)	Nguyen Minh Tuan Director 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 Johnson & Johnson Vietnam
	Industry (secondary representative)	Cao Thi Ai Lien Philips Vietnam
Yemen	Regulatory Authority (primary representative)	Mr. Safwan Ali Al Aoudi Approval director Import department Supreme Broad For drugs and medical appliances Ministry of Health Yemen
	Regulatory Authority (secondary representative)	Nil
	Industry (primary representative)	Nil
	Industry (secondary representative)	Nil
Zimbabwe	Regulatory Authority (primary representative)	MS G.N. Mahlangu Director General Medicines Control Authority of Zimbabwe Zimbabwe
	Regulatory Authority (secondary representative)	Mr R. Rukwata Head Licensing and Enforcement Division Medicines Control Authority of Zimbabwe Zimbabwe
	Industry (primary representative)	Nil
	Industry (secondary representative)