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	Regulatory Authority
Co-Chair:	Mr. Ee Bin Liew Group Executive Director Access-2-Healthare	Industry
Advisor:	Mr. Hideki Asai Senior Fellow MED MIRAI Inc Japan	Industry
Advisor:	Dr. Ir. Peter W.J. Linders Director Global Standards & Regulations of Philips Healthcare Netherlands	Industry
Secretariat	Ms. Annie Yin Senior RA/QA/ Driector J & J Medical China 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