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 |
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)
|
Ahmad Shariff
Chief Executive
Medical Device Authority
Ministry of Health
Malaysia
|
|
Regulatory Authority
(secondary representative)
|
Salbiah Yaakop
Director, Policy, Codes & Standards Division
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) |
Nil |
