Work Group 7 (WG7) - Quality Management System: Operation & Implementation

Chair: Mr. WANG Ai Jun
Director
Center for Food and Drug Inspection
CFDA
People's Republic of China
Regulatory Authority
Co-Chair: Mr. Ee Bin Liew
Owner and consultant
Access-2-Healthcare
Singapore
Industry
Advisor:

Mr. Hideki Asai
Chief Engineer
Quality Assurance Division
Hitachi High-Tech Science Corporation
Japan

Industry
Secretariat Ms. Chloe Hyosung Lee
Senior RA/QA/Reimbursement Specialist
BARD Korea Ltd
Republic of Korea
Industry
Member: Mr. Kyoung-taek, Lim
Assitant Director
Ministry of Food and Drug Safety
Republic of Korea
Regulatory Authority
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)
Abu Dhabi
Industry
Member: Mr. Tony Low
Business Development Manager 
BSI Product Service
Malaysia
Industry
Member: Ms. Yean Ting Ong
Johnson & Johnson Medical
Malaysia
Industry
Member: Mr. Sateesh Yelisetti
Baxter
Singapore
Industry
Member: Mr. Jing Nie
Regulatory Manager
Johnson & Johnson Medical AP NPD&NBD
Johnson & Johnson Medical (Shanghai) Ltd. 
China
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: Ms. Nashirah Naiimi
Medical Device Authority 
Ministry of Health Malaysia
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

 

 

WG7 Documents

 

1. AHWP/WG7/F001:2014

Title: Guidance on Medical Device Quality Management System - Requirements for Distributors

Date: 21 Nov 2014

Download file:Final_AHWP_WG7_F001_2014.pdf

 

2. AHWP/WG3/F001:2013 (now restructured to WG7)

Title: Quality management system – Medical devices – Nonconformity Grading System for Regulatory Purposes and Information Ex-change

Date: 6 Dec 2013

Download file:Final_AHWP_WG3_F001_2013.pdf