Members

Submitted by admin on Tue, 09/20/2016 - 00:13
AHWP Chair :  Mr. Ali M. AL-DALAAN, Vice Executive President, Medical Device Sector, Saudi Food and Drug Authority, Kingdom of Saudi Arabia
AHWP Vice-Chair (Regulatory Authority): Mr. GAO Guobiao, Deputy Director General, Medical Device Registration Dept., China FDA, People's Republic of China
AHWP Vice-Chair (Industry): Ms. Quan TRAN, Head of Regulatory & Government Affairs and Quality Assurance Asis Pacific, Invisalign Singapore Pte Ltd. , Singapore 

 

Brunei Darussalam 

Regulatory Authority (primary representative)

PH Saadiah PMH Hashim
Chief Information Office
Healthcare Technology Department
Ministry of Health
Brunei Darussalam

Regulatory Authority (secondary representative)

Abidin Bin Haji Othman
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)
Ms. Shu-Fen WANG
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
CEO
Coreleader Biotech Co. Ltd.
Chinese Taipei

Industry
(secondary representative)

Mr. Albert T.W. Li
Industrial Technology Research Institute
(CAB of DOH)
Chinese Taipei


Hong Kong SAR, China 
Regulatory Authority
(primary representative)
Dr. CHEUNG Yung-yan, Terence
Principal Medical & Health Officer
Medical Device Control Office
Department of Health
Hong Kong SAR, China
Regulatory Authority
(secondary representative)

Dr. Gary YING
Senior Medical & Health Officer,
Medical Device Control Office
Department of Health
Hong Kong SAR, China

Industry
(primary representative)

Mr. Jack WONG
Associate Vice President, Regulatory Affairs,
Asia Pacific, Middle East & Africa, Allergan  

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
QR Synergies
India
Industry
(secondary representative)
Vibhav Garg
VP Health Policy & Govt. Affairs,
GE India
India

Indonesia 
Regulatory Authority
(primary representative)

Drg. Arianti Anaya
MKM
Director of Medical Device Production and Distribution Service
Ministry of Health, Republic of Indonesia
Indonesia

Regulatory Authority
(secondary representative)

Mr. Lupi Trilaksono
SF, MM, Apt
Head of Section
Medical Device and Household Health Product Certification
Directorate of Medical Devices Production and Distribution
Directorate General of Pharmaceutical and Medical Device Service
Ministry of Health, Republic of Indonesia
Indonesia

Industry
(primary representative)

Mr Ade Tarya Hidayat
Chair
ASPAKI
Indonesia Medical Device Manufacturer Association
Indonesia

Industry
(secondary representative)
Dr. Cristina Sandjaja M.Kes MM     
Director PT. Prodia Diagnostic Line - Indonesia

Jordan 
Regulatory Authority
(primary representative)
Dr. Anan Abu Hassan
Director Assistant Of Medical Devices & Instruments Directorate
Head Of Cosmetics Department
JFDA
Amman-Jordan
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 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
Executive Director
Saudi Food & Drug Authority
Kingdom of Saudi Arabia
Industry
(primary representative)
Mr. Fahad Al Moammar
Saudi Arabia Industry
Kingdom of Saudi Arabia
Industry
(secondary representative)
Mr. Faisal Mansour Matbuli
Saudi Arabia Industry
Kingdom of Saudi Arabia

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
Deputy Chief of Drug Control Division
Food and Drug Department Ministry of Health
Laos PDR
Regulatory Authority
(secondary representative)
Ms. Soulyvanh Keokinnaly
Technical staff of Drug Control Division
Food and Drug Department Ministry of Health
Laos PDR
Industry
(primary representative)
Ms. Quan TRAN
Vice President
Regulatory Affairs
Asia Pacific Medical Technology Association (APACMed)
Industry
(secondary representative)
 Nil

Malaysia

Regulatory Authority
(primary representative)

 

Ahmad Shariff
Chief Executive
Medical Device Authority
Ministry of Health
Malaysia

Regulatory Authority
(secondary representative)

 

Sasikala Devi Thangavelu
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. Noor Muhammad SHAH
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)

Muhammad Sohail
Manager Regulatory Affairs
Fresenius Medical Care Pakistan Private Ltd
Pakistan


People's Republic of China 

 
Regulatory Authority
(primary representative)
Guo Biao GAO
Deputy Director General
Medical Device registration Department
China Food and Drug Administration
People's Republic of China
Regulatory Authority
(secondary representative)
Xianghui Yue
Deputy Division Director
Medical Device Supervision and Evaluation
Division, Medical Device Supervision Department
China FDA
Industry
(primary representative)
Mr. Hengkun Zhao
Deputy Division Director
Regulatory Affairs Director
WEGO Group
Industry
(secondary representative)
Ms. Amber Wang
Vice President
Regulatory Affairs and Quality Assurance
Smith & Nephew Ltd. China

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
Cardiovascular Medical Devices Division
Medical Device Safety Bureau
Ministry of Food and Drug Safety (MFDS)
Republic of Korea
Regulatory Authority
(secondary representative)
Dr. Hye-Won Roh
Deputy Scientific Director
Medical Device Policy Division
Ministry of Food and Drug Safety (MFDS)
Republic of Korea
Industry
(primary representative)
Ms. Eun-Hee Cho
Manager for RA/QA/Reimbursement
Abbott Korea
Republic of Korea
Industry
(secondary representative)
Ms. Hye-Kyung Chung, Rachel
Managing Director, Medical Device Group 1
Synex Consulting Ltd.
Republic of Korea

Singapore 
 
Regulatory Authority
(primary representative)

Dr. Rama Sethuraman
Deputy Director
Health Sciences Authority
Singapore

Regulatory Authority
(secondary representative)
Ms. Liew Lai Ling
Senior Regulatory Specialist
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)

Dr. Hiiti B. Sillo
Director General
Tanzania Food and Drug Authority

Regulatory Authority
(Secondary representative)
Adam Mitangu Fimbo
Tanzania Food and Drug Authority
Tanzania
Industry
(Primary repressentative)
 Nil
Industry
(Secondary representative)
 Nil

Thailand 
 
Regulatory Authority
(primary representative)

Mrs. Korrapat TRISRNSRI
Director of Medical Device Control Division&
Medical Device Control Division
Thailand
 

Regulatory Authority
(secondary representative)

Mrs. Sirinmas KATCHAMART
Senior Pharmacist
Medical Devices Control Division
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

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