Work Group 7 (WG7) - Quality Management System

Submitted by admin on Fri, 06/02/2017 - 16:52
Chair:

Mrs. CHEN Yan
Director
Division of Inspection Five
Center for Food and Drug Inspection (CFDI) of NMPA
People's Republic of China

Email: cheny@cfdi.org.cn

Regulatory Authority

Co-Chair:

Mr. Ee Bin Liew
Group Executive Director
Access-2-Healthare

Email: eebin.liew@access2hc.com 

Industry
Advisor:

Mr. Hideki Asai
Senior Fellow
MED MIRAI Inc
Japan

Industry
Advisor: Dr. Ir. Peter W.J. Linders
Former Director
Global Standards & Regulations of Philips Healthcare
Netherlands
 
Industry
Secretariat Ms. Annie Yin
Vice President
Medical Regulatory Affairs
Roche Diagnostics (Shanghai) Limited
People's Republic of China
Industry
Member: Mr. Abdullah AL RASHEED 
Compliance and Enforcement 
Executive Director
Saudi Food and Drug Authority
Regulatory Authority
Member: Mr. Kyoung-taek, Lim
Assitant Director
Ministry of Food and Drug Safety
Republic of Korea
Regulatory Authority
Member: Zaied Khaled Al Khamaali
Executive director of laboratories
Saudi Food and Drug Authority
Kingdom of Saudi Arabia
Regulatory Authority
Member: Mohammed Saleh Al-Hayan
Director of Surveillance
Saudi Food and Drug Authroity
Kingdom of Saudi Arabia
Regulatory Authority
Member: Ms. Nashirah Naiimi
Principal Assistant Director of Policy, International Affairs & Industry Facilitation Division
Medical Device Authority 
Ministry of Health Malaysia
Malaysia
Regulatory Authority
Member: Ms. Michelle NOONAN
International Regulatory Policy Analyst
U.S. Food and Drug Administration
USA
Regulatory Authority
Member: Ms. LEE Szu-Yu
Specialist/GMP Inspector
Taiwan Food & Drug Administration
Chinese Taipei
Regulatory Authority
Member: Dr. Adel Ahmad ALHAJJI
Medical supply administration
Ministry of health
State of Kuwait
Regulatory Authority
Member: Mr Kyoung Taek LIM
Assistant Director
MFDS
Republic of Korea
Regulatory Authority
Member: Mr Marc-Henri WINTER
Program analyst / Medical device Single Audit Program
U.S. Food and Drug Administration
Sultanate of Oman
Regulatory Authority
Member: Ms. Ghaliya Alqaidi
Section Head of Medical Device Registration
Ministry of Health
USA
Regulatory Authority
Member: Ms. Qi ZHANG
Staff of Quality Management Department
Center for Medical Device Evaluation
People's Republic of China
Regulatory Authority
Member: Mr. Chee Chong Vincent LAM
Senior Product Specialist
TUV SUD Product Service
Industry
Member: Ms. Huang JIE
AD Quality assurance & Regulatory Compliance
Smith & Nephew Shanghai
People's Republic of China
Industry
Member: Mr. Olzhas Akhmetsadyk
Head of Medical Device Testing Laboratory
National Center for Expertise of Medicines,
Medical Devices and Medical Equipment,
Ministry of Healthcare
Republic of Kazakhstam
Industry
Member: Mao Hongjiang
Senior Quality Director
J & J Medical Orthopedics
People's Republic of China
Industry
Member: Mr. Jizhong Jin
Senior Regulatory Affairs Associate
3M Medical Division
China
Industry
Member: Mr. Reem El Sayed Uae
Regulatory Affairs Manager Middle East Region
GE Healthcare Holding ME SA (DIC)
United Arab Emirates
Industry
Member: Mr. Tony Low
Director of Human Performance and Medical QA/RA
Commissioning Agents International (CAI)
Malaysia
Industry
Member: Ms. Yean Ting Ong
Johnson & Johnson Medical
Malaysia
Industry
Member: Mr. Sateesh Yelisetti
Baxter
Singapore
Industry
Member: Ms. Jing Crystal Nie
Director Regulatory Affairs & Regulatory Compliance (China)
MicroVention Inc., subsidiary of Terumo Corporation
Industry
Member: Mr. Kulveen Singh Bali
Regulatory Affairs & Quality Assurance
3M Health Care Business
India
Industry
Member:

Dr. Nizamil Fairuz Yahya
Managing Consultant, Quality Operations
PharmEng Technology
Malaysia

Industry
Member:

Mr. Albert T.W. Li
Industrial Technology Research Institute
Chinese Taipei

Industry
Member: Mr Su Seob LIM
Head of Quality & Technology (RA, QM, EHS)
Siemens Limited Seoul (Siemens, Healthcare in South Korea)
Republic of Korea
Industry
Member: Ms. JIANG Ahong
Director Regulatory Affairs
BD
People's Republic of China
 
Industry
Member: Mr. Alex Jiang
QA/ RA VP
Fosun Diagnostics (Shanghai) Ltd
People's Republic of China
Industry
Member: Mr. Asok KUMAR
J & J Medical India
India
Industry
Member: Ms. Fong An LEE
Deputy Director, Principal Administrator
Office of Medical Device Evaluation
Center for Measurement Standards
Industrial Technology Research Institute 
Chinese Taipei
Industry
Member: Ms. Xiaohua, Jessie LI
Johnson & Johnson Medical (Suzhou) Ltd.
People's Republic of China
Industry
Member: Mr. Tony LOW
Manager
BS-P Medical South East Asia
TUV Rheinland
Malaysia
Industry
Member: Ms. Xiaohua, Jessie LI
Johnson & Johnson Medical (Suzhou) Ltd.
People's Republic of China
Industry
Member: Mr. Vidya SHANKAR
Sr Manager - Quality
Philips Electronics India Ltd, Healthcare Sector
India
Industry
Member: Ms. TAN Hwee Ee
DH RegSys Pte. Ltd.
Singapore
Industry
Member: Mr. FAN Hong Teng, Kelvin
QM Manager
Sysmex Asia Pacific Pte Ltd
Singapore
Industry
Member: Ms. NARAYAN Murthy Indira B
Head - Regulatory, Quality & Compliance,
India & South Asia
Abbott India
Industry
Member: Ms. SUMATI  Randeo
Associate Director
Regulatory Strategy & Advocacy
Strategic RA Asia Pacific
Abbott Quality and Regulatory
Abbott Laboratories
India
Industry
Member: Mr. Albert Tzu-Wei Li
Director, Principal Administrator
Office of Medical Device Evaluation
Center for Measurement Standards
Industrial Technology Research Institute 
Chinese Taipei
Industry
Member: Ms. Jennifer HAN 
Supervisor/RA/Qsuality system
3M China Limited
China
Industry
Member: Ms. Nishith DESAI
Director of Regulatory Affairs, New Products, Asia
COVIDIEN PRIVATE LTD
Singapore 
Industry
Member: Ms. Hailey CHU
Regulatory Lead
British Standard Institution (BSI)
Chinese Taipei
Industry
Member: Ms. Melody Kwok
Regulatory & Quality Consultant
ARQon Pte Ltd
Singapore
Industry
Member: Mr. L.Praveen Kumar
Director
Quality, Regulatory Affiars & EHS
India Medtronic Pvt. Ltd
Industry
Member: Ms Rachel Chung
Managing Director, Medical Devie Group 1
Synex Consulting Ltd.
Republic of Korea
Industry
Member: Ms Ji Yeun KIM
Director
RAQA / Reimbursement
Stryker Korea
Republic of Korea
Industry
Member: Ms Latika Vats
Director
Regulatory Affairs & Quality Assurance
Terumo India Private Limited
India
Industry
Member: Ms. Meng Rung Joanna CHIANG
ISO 13485 Product manager/ Senior client manager
BSI Group
Chinese Taipei
Industry
Member: Ms. GAO Yinghui
Policy & Regulation Director
Johnson & Johnson Medtech
People's Republic of China
Industry
Member: Ms. LIU Meirong Minna
Global Regulatory Affairs Vice President
Venus Medtech (Hangzhou) Inc.
People's Republic of China
Industry
Member: Ms. WU Jiong Sandy
Site Quality Director
GE Healthcare
People's Republic of China
Industry
Member: Mr. Peter Lee
Associate Director
International RA Digital
Institut Straumann AG
Switzerland
Industry
Member: Ms. Amber Wang
VP, RAQA
Genesis MedTech China
People's Republic of China
Industry
Member: Dr. Yun Sun
Vice Preseident of Regulatory & Medical Affair
B. Braun Medical (Shanghai)
People's Republic of China
Industry
Member: Ms. Xi Chen
Vice General Manager, Regulation Affairs
Sinovation (Beijing) Medical Technology CO., LTD.
People's Republic of China
Industry
Member: Ms. Chunyu Gao
Senior Director, Quality & Regulatory & Clinical Affairs
Stryker China
People's Republic of China
Industry
Member: Ms. Liqin Li
Senior Manager, Regulatory Affaris & Clinical Affairs
Stryker (Beijing) Healthcare Product Co., Ltd.
People's Republic of China
Industry


Guidance Documents: 

FINAL_imdrf-tech-140918-assessment-decision-process-141013

FINAL_imdrf-tech-131209-competence-and-training-requirements-140901 

FINAL_imdrf-tech-131209-auditing-requirements-140901

FINAL_imdrf-proc-140918-decision-related-processes

GHWP WG7 F001 2014 rev ISO 13485 2016 final (1)_R2

Guidance on Medical Device Quality Management System_Requirements for Distributors_FINAL document 

Final_GHWP_WG3_F001_2013 

GHWP GUIDANCE DOCUMENT_WG3N18

WG3 v4N17


Work Plan and Target: 

GHWP_TC_WG03_Work Plan 2012-2014