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

Chair: Dr. Youngwoo Bae 
Assistant Director
Orthopedic & Restorative Devices Division, Dept. of Medical Device Evaluation, Ministry of Food and Drug Safety (MFDS)
Republic of Korea
 Regulatory Authority
Co-Chair: Mr. Tony YIP
Associate Director
Regulatory Affairs
APAC Grifols (HK) Limited
Hong Kong SAR
 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: Dr. Abdullatif Sulaiman Al Watban
Director
National Center for Medical Devices Researches and Information
Kingdom of Saudi Arabia
Regulatory Authority
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: 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: Pavan Kumar Malwade
Regulatory Affairs Manager
Carl Zeiss India (Bangalore) Pvt. Ltd.
India
Industry