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:  NIL  
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
China
 Industry
Member: Mr. John BABY
Managing Director
Quality Systems and Solutions Pte Ltd
Singapore
Industry
Member: Mr. Kelvin Hong Yap KOH
Senior Manager
Regulatory Affairs Asia
Pall Filtration 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
Assistant RA 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