Chair: |
Mrs. CHEN Yan |
Regulatory Authority |
Co-Chair: |
Mr. Ee Bin Liew Group Executive Director Access-2-Healthare |
Industry |
Advisor: |
Mr. Hideki Asai |
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: | 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 |
Industry |
Member: |
Mr. Albert T.W. Li |
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 QRA Manager Beckman Coulter Taiwan Inc. 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 |
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
Work Plan and Target:
GHWP_TC_WG03_Work Plan 2012-2014