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: peace_within@hotmail.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: Mohammed Saleh Al-Hayan
Director of Biometrics (Director of Surveillance)
Saudi Food and Drug Authority
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. Ghaliya Alqaidi
Section Head of Medical Device Registration
Ministry of Health
Sultanate of Oman
Regulatory Authority
Member: Ms. Qi ZHANG
Staff of Quality Management Department
Center for Medical Device Evaluation
People's Republic of China
Regulatory Authority
Member: Dr. Ahmed Salah Mohamed Kahla
Senior Inspector
Egyptian Drug Authority
Egypt
Regulatory Authority
Member: Ms. Dina Nasry Ayoub
Imported Medical Devices Inspection Unit Head
Egyptian Drug Authority
Egypt
Regulatory Authority
Member: Mr. Haninu Salumu Nakuchema
Medical Devices Officer I
Tanzania Medicines and Medical Devices Authority
Tanzania
Regulatory Authority
Member: Mr. Yang Chen
Medical Device Section Chief
Sichuan Technical Inspection Center for Medical Products
People's Republic of China
Regulatory Authority
Member: Ms. Gudula Sabina Mpanda
Principal Medical Devices Officer
Tanzania Medicines and Medical Devices Authority
Tanzania
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)
United Arab Emirates
Industry
Member: Ms. Yean Ting Ong
Head Quality & Regulatory
Roche Diagnostics (M) Sdn. Bhd
Malaysia
Industry
Member: Mr. Sateesh Yelisetti
Head Quality & Regulatory
Roche Diagnostics (M) Sdn. Bhd
Malaysia
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. Alex Jiang
QA/ RA VP
Fosun Diagnostics (Shanghai) Ltd
People's Republic of China
Industry
Member: Mr. Asok KUMAR
Abbott
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
Senior Registration Manager
J&J Medical China
People's Republic of China
Industry
Member: Ms. Xiaohua, Jessie LI
Johnson & Johnson Medical (Suzhou) Ltd.
People's Republic of China
Industry
Member: Ms. TAN Hwee Ee
Founder/Principal Consultant
DH RegSys Consulting Pte Ltd
Singapore
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 
Consultant
Ao Quan Medical Tech 
People's Republic of China
Industry
Member: Ms. Hailey CHU
Regulatory Lead
British Standard Institution (BSI)
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: 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
Member: Ms. Heli Liu
Senior Director, Regulatory Affairs and Quality Assurance, APAC, Align Technology
People's Republic of China
Industry
Member: Ms. Linda Liu
Chief Quality Officer
Shangdong Weigao Group Medical Polymer 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