Submitted by nguyen on Thu, 06/29/2017 - 20:56


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. Tommy Lam
Senior Electronics Engineer
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)

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)

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 TingOng Yean Ting
Head
Quality and Regulatory
Roche Diagnostics Malaysia Sdn Bhd

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
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)

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