Work Group 7 (WG7) - Quality Management System

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