Submitted by admin on Fri, 06/02/2017 - 16:44
Chair:

Mr. Chun-Jen Chien
Technical Specialist
Food and Drug Administration
Ministry of Health and Welfare
Chinese Taipei

Email: i64901037@fda.gov.tw 

 Regulatory Authority
Co-Chair:

Mr. Tony YIP
Associate Director
Regulatory Affairs
Asia Pacific
Grifols (HK) Limited
Hong Kong SAR

Email: tony.yip@grifols.com

 Industry
Advisor: Dr. Ir Peter W. J. Linders
Director, Global Regulations & Standards
Philips
Netherlands
Industry 
Advisor: Dr. Koen Cobbaert
Senior Manager - Quality, Standards & Regulations
Global Regulations and Standards
Philips
Netherlands
Industry 
Secretary Dr. Tailor Tai-Long  Chen
Reviewer
Food and Drug Administration
Ministry of Health and Welfare
Chinese Taipei
Regulatory Authority
Member: Ms. Elisa PRITHA
Medical Device Evaluator
Ministry of Health
Republic of Indonesia
Regulatory Authority
Member: Ms. Young-min Han
Assistant Director
Ministry of Food and Drug Safety
Republic of Korea
Regulatory Authority
Member: Ms. Marwa AL SHEHEIMI
Section Head
Low Risk Registration Section
Ministry of Health
Sultanate of Oman
Regulatory Authority
Member: Ms. Zahra AL-HOOTI
Biomedical Engineer
High Risk Registration Section
Ministry of Health
Sultanate of Oman
Regulatory Authority
Member: Mr. Chih-Chung Chien
Officer
Food and Drug Administration Ministry of Health and Welfare
Chinese Taipei
Regulatory Authority
Member: Dr. Liang PENG
Deputy Division Director
Center for Medical Device Evaluation of NMPA
People's Republic of China
Regulatory Authority
Member: Mr. Hong LIANG
Reviewer
Center for Medical Device Evaluation of NMPA
People's Republic of China
Regulatory Authority
Member: Dr. Hala ALHODAIB
Senior Scientific Evaluation Expert
Saudi Food & Drug Authority
Kingdom of Saudi Arabia
Regulatory Authority
Member: Mr. Yazid ALAZWARI
Head of New Technologies Assessment
Saudi Food & Drug Authority
Kingdom of Saudi Arabia
Regulatory Authority
Member: Mr. Mohammed ALAMER
Radiation Safety and Protection Standards Designated Head Section
Saudi Food and Drug Authority
Saudi Arabia
Regulatory Authority
Member: Dr. Wenbo Liu
Reviewer
Center for Medical Device Evaluation of NMPA
People's Republic of China
Regulatory Authority
Member: Mr. Ce Yang
Reviewer
Center for Medical Device Evaluation of NMPA
People's Republic of China
Regulatory Authority
Member: Prof. Chenxi Wang
Senior Engineer, Division of Active Medical Devices and Medical Optics, Institute for Medical Devices Control, National Institutes for Food and Drug Control
People's Republic of China
Regulatory Authority
Member: Mr. David Aden Mwakyoma
Medical Devices Officer
Tanzania Medicines and Medical Devices Authority (TMDA)
Tanzania
Regulatory Authority
Member: Dr. Lindsay TAO
Corporate Director
Global Health Policy
Johnson & Johnson
Industry
Member: Mr. John BABY
Managing Director
Quality Systems and Solutions Pte Ltd
Singapore
Industry
Member: Mr. Kelvin Hong Yap KOH
Director
APAC Regulatory Affairs
Terumo BCT Asia Pte Ltd.
Singapore
Industry
Member:

Ms. Jacqueline Monteiro
Director
Quality Assurance and Regulatory Affairs
Philips HealthTech
Singapore

Industry
Member: Ms. Lesley TEE
Assistant Manager, Quality and Regulatory
Philips Electronics Singapore Pte Ltd
Singapore
Industry
Member: Mr. Sundeep Agarwal
General Manager
Datt Mediproducts PVT. Limited
India
Industry
Member: Ms. Shing Koon CHENG
Regulatroy Affairs Manager
Boston Scientific Asia Pacific Pte Ltd
Singapore
Industry
Member: Ms. Young Jin LEE
Senior Manager, Quality & Regulatory
Philips
Republic of Korea
Industry
Member: Mr. Wonbin KIM
General Manager
VATECH Co., Ltd.
Republic of Korea
Industry
Member: Dr. Hun Shim
Associate Researcher
Wonju Medical Insstry Technovalley
Republic of Korea
Industry
Member: Dr. Duc Duong-Hong
Regulatory Affairs Manager,SEA
Edwards Lifesciences (ASIS) Pte. Ltd.
Singapore
Industry
Member: Mr. Pavan Kumar Malwade
Deputy General Manager
Quality & Regulatory Affairs
Siemens Healthineers India LLP
India
Industry
Member: Dr. Ganesh Babu
Head Clinical & Regulatory Affairs
Carl Zeiss India (Bangalore) Pvt Ltd
Industry
Member: Dr. Sheng-Hui LIAO
Engineer
Industrial Technology Research Institute
Chinese Taipei
Industry
Member:

Ms. Jin CUI
Regulatory Affairs Director
Abbott China

Industry
Member: Ms. Yasha HUANG
Head of Regulatory Policy, APAC
Roche
Singapore
Industry
Member: Mr. Sharad Manasvi Shukla
Director
Regulatory Affairs, MedTech, Johnson & Johnson
Singapore
Industry
Member: Mr. Qin Chuan
Senior regulatory affairs manager-digital healthcare
GE Healthcare China
People's Republic of China
Industry
Member: Ms. LanLan (Lannice) Wu
Quality Assurance & Regulatory Affairs Senior Vice President
Hanalytics Pte. Ltd.
Singapore
Industry
Member: Mr. Winson Teng
Global Regulatory Affairs Intelligence Manager
Becton Dickinson and Company
Singapore
Industry
Member: Mr. Ting-Han CHIEN
Section Chief
Center for Drug Evaluation
Chinese Taipei
Industry
Member: Ms. Weijie XIA
Regulatory Affairs Manager
Medtronic
People's Republic of China
Industry
Member: Ms. Youngchan Cho (Elly)
RA & CA manager
Philips
Republic of Korea
Industry
Member: Ms. Qian Dong
Head of Regulatory Intelligence, APAC, Align Technology
People's Republic of China
Industry
Member: Mr. Hideki Asai
Senior Fellow
MED MIRAI Inc.
Japan
Industry
Member: Ms. Wendy (Chiao-Wen) Shen
Head of Regulatory Affairs
Johnson & Johnson Medical Taiwan Ltd. 
Chinese Taipei
Industry
Member: Ms. Huang Valerie
Assistant Manager, Regulatory Affairs, APAC
Terumo Asia Pte Ltd
Singapore
Industry
Member: Ms. Wang Rong 
QARA  & HEPR VP
Medtronic Greater China
People's Republic of China
Industry
Member: Dr. Lei Wang
Director of Imaging AI
Siemens Shanghai Medical Equipment Ltd.
People's Republic of China
Industry
Member: Ms. Wella Wei
China RAQA Director
Align Technology Co. Ltd.
People's Republic of China
Industry
Member: Ms. Dun Jhu Yang
Senior Regulatory Affairs Specialist
Acer Medical Inc.
Chinese Taipei
Industry
Member: Mr. Jason Guo
APACE RA Director
Abbott China
People's Republic of China
Industry
Member: Dr. Ching-Yi Kuo
Client Manager/ Auditor
Service Delivery (Medical Device)
APAC Service Delivery
British Standards Institution (BSI Group)
Chinese Taipei
Certification Body/ Notified Body


Guidance Documents: 

FINAL_GHWP-WG3-SaMD-002_Risk Categorisation of SaMD Final (2) SR