Work Group 1 (WG1) - Pre-Market Submission and CSDT

Submitted by admin on Wed, 09/28/2016 - 22:48

  

Chair: Dr. Seil Park
Assistant Director
Division of High-Tech Medical Devices
Ministry of Food and Drug Safety
Republic of Korea		 Regulatory Authority
Co-Chair:

Ms. Mandy Myoung Shim Kim
Senior Regulatory Affairs Manager, Korea
Johnson & Johnson Medical
Republic of Korea

 Industry
Advisor:

Dr. Arthur Brandwood
Principal Consultant
Brandwood Biomedical
Australia

 Industry
WG 1 Secretary: 

Ms. Yesong PARK
Sr. RA Specialist
Johnson & Johnson Medical
Republic of Korea

 Industry
Member: Mr. Alamri Mesha'l
Executive Director
Premarket & Scientific Evaluation Management
Medical Devices Sector 
Saudi Food & Drug Authority
Kingdom of Saudi Arabia		 Regulatory Authority
Member: Mr. Samwel Hhayuma
Biomedical Engineer
Tanzania Food & Drugs Authority
Tanzania		 Regulatory Authority
Member:
Mr. Gulnar Berkimbayeva
Head of Department of Primary Expertise
Medical Devices National Center
Kazakhstan
Regulatory Authority
Member:
Mr. Fikrisyah Bin Irman
Medical Device Evaluator, Directorate of Medical Device and Household Health Product Evaluation
Ministry of Health
Indonesia
Regulatory Authority
Member:
Ms. Sookyeong Shin
Department of Medical Device Evaluation
Ministry of Food & Drug Safety
Republic of Korea
Regulatory Authority
Member:
Mr. Kenneth Cavanaugh
Deputy Director, Officer of Cardiovascular Devices
U.S. Food and Drug Administration Center for Devices and Radiological Health
USA
Regulatory Authority
Member: Dr. Felista Chepwogen
Head of medical devices and diagnostics department
National Medicines Regulation Officer
Kenya		 Regulatory Authority
Member: Ms. Faiza Said AL Zadjali Eng
Director of Medical Device Control DGPA & DC
Ministry of Health Sultanate of Oman
Sultanate of Oman		 Regulatory Authority
Member: Ms. Hanadi Alousaimi
Senior Scientific Evaluation Specialist
Saudi Food and Drug Authority
Kingdom of Saudi Arabia		 Regulatory Authority
Member:
Ms. Ming Hao Tan
Manager
Regulatory Associates LLP
Singapore
Industry
Member:
Mr. Grant Bennet
Director & CEO
Brandwood Biomedical
People's Republic of China
Industry
Member:
Ms. Minghua Chen
Business Development Manager Asia‑Pacific, Senior Consultant
Qserve Group China Ltd
People's Republic of China
Industry
Member:
Ms. Sheryl Hsiao
Regulatory Affairs and Compliance Asia Manager
3M
Singapore
Industry
Observer:
Dr. Peter W.J. Linders
Director, Standards & Regulations, Global Quality & Regulatory
Philips Healthcare
The Netherlands
Industry
Member:
Mr. Pavan Kumar Malwade
Deputy General Manager
Quality & Regulatory Affairs
Siemens Healthineers India LLP
India
Industry
Member:
Ms. Victoria Qu
Director, Regulatory Affairs
Abbott Laboratories
People's Republic of China
Industry
Member:
Mr. Sanoj Prabhakaran
Regulatory Affairs Manager, Middle East, North Africa & Turkey, where Oman, UAE and Saudi Arabia
Becton Dickinson
Kingdom of Saudi Arabia
Industry
Member:
Mr. NG Swee Choong
Sr. Engineer
Cook Asia Limited
Hong Kong SAR
Industry
Member:
Mr. Tony Yip
Associate Director, Regulatory Affairs, Asia Pacific
Grifols (HK) Limited
Hong Kong SAR
Industry
Member:
Ms. Chiew Teng Chuah
Manager, EHS & Regulatory
3M Malaysia Sdn Bhd
Malaysia 
Industry
Member:
Mr. Edward Woo
Sr. Dir. RA, Asia Pacific
Varian Medical Systems Pacific, Inc.
Hong Kong SAR
Industry
Member:
Ms. Yusyanti Mat Tahir
Manager, Regulatory Affairs
Becton Dickinson
Singapore 
Industry
Member:
Ms. Youngsoon Jeon
Sr. RA/QA/Reimbursement Manager, RA/QA/RIP Department
Bard Korea Ltd.
Republic of Korea
Industry
Member:
Mr. Youngsoo Seol
QMR
ILOODA CO., LTD.
Republic of Korea
Industry
Member:
Mr. Kulveen Bali Singh
Manager - Regulatory Affairs
3M India Limited
India
Industry
Observer:
Mr. Keiichiro Ozawa
Regulatory Specialist, Medical Device
FUJIFILM Corporation
Japan
Industry
Member:
Dr. Henry Hou
Regulatory Affairs Manager
Elekta Limited
Hong Kong SAR
Industry
Member:
Mr. Asok Kumar
Director Global Strategic Regulatory Affairs
Abbott Laboratories
India
Industry
Member:
Ms. Jyotsna Yadav
Sr. Manager
Smith & Nephew
Dubai, UAE
Industry
Member:
Ms. Yesong PARK
Sr. RA Specialist
Johnson & Johnson Medical
Republic of Korea
Industry
Member: Mr Sharad Manasvi Shukla
Director Regulatory Affairs, MedTech
Johnson & Johnson Medical 
Singapore		 Industry
Member: Ms. Nasreen AlQuaid
Staff Regulatory Affairs Specialist
Becton Dickinson 
USA		 Industry
Member: Mr. Inho Dan
Sr. Quality and Regulatory Affairs Manager - ANZ, Emerging Asia and Korea
Cordis Korea Ltd
Republic of Korea		 Industry
Member: Ms. Qiong Wu
RA Director
Johnson and Johnson Medical (Shanghai) Ltd
People's Republic of China		 Industry
Member: Ms. Hana Lee
RA Manager
Mindray Korea
Republic of Korea		 Industry
Member: Ms. Jean Lei
Regulatory Affairs Manager
Shenzhen Mindray Biomedical Electroics Co. Ltd
People's Republic of China		 Industry
Member: Ms. Jing Crystal Nie
Director Regulatory Affairs & Regulatory Compliance (China)
MicroVention Inc.,subsidiary of Terumo Corporation
People's Republic of China		 Industry


Guidance Documents: 

FINAL_GHTF SG1 Definition of the Terms

FINAL_GHWP_WG_Proposed_Final_Comb_ Prod_Guidance-241116


Work Plan and Target: 

GHWP_TC_WG01_Work Plan 2012-2014