Work Group 3 (WG3) - Pre-market: Software as a Medical Device

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 
Secretary Ms. Youngchan Cho (Elly)
RA & CA manager
Philips
Republic of Korea
Industry
Member: Ms. Elisa PRITHA
Medical Device Evaluator
Ministry of Health
Republic of Indonesia
Regulatory Authority
Member: Ms. Young-min, Han
Assitant 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: Ms. Anindita SAHA
Assistant Director
Digital Health Center of Excellence
US Food and Drug Administration
United States of America
Regulatory Authority
Member: Mr. Wil VARGAS
General Engineer
Digital Health Center of Excellence
US Food and Drug Administration
United States of America
Regulatory Authority
Member: Mr. Chien Chih-Chung
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: 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: Mr. Pat Baird
Senior Regulatory Specialist
Philips
United States of America
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


Guidance Documents: 

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