Chair: | Mr. Abdullah AL RASHEED Compliance and Enforcement Excutive Director Saudi Food & Drug Authority Kingdom of Saudi Arabia |
Regulatory Authority |
Co-Chair: |
Mr. Vincent Chee-Choong LAM Senior Product Specialist TUV SUD Product Service TUV SUD Malaysia |
Industry |
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 USA |
Regulatory Authority |
Member: | Mr. Asok KUMAR J & J Medical India India |
Industry |
Member: | Dr. Vincent Chee Choong LAM Certification and Inspection Manager TUV-SUD-PSB (Malaysia) Sdn. Bhd. Malaysia |
Industry |
Member: | Ms. Fong An LEE Deputy Manager 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: | 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 |
Industry |
Member: | Mr. Albert LI T.W. Manager 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 |
Industry |
Member: |
Ms Ji Yeun KIM |
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 |
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-WG4-Nov2012-FINAL (part1)
GHWP-WG4-Nov2012-FINAL (part2)
GHWP-WG4-Nov2012-FINAL (part3)
GHWP-WG4-Nov2012-FINAL (part4)
GHWP-WG4-Nov2012-FINAL (part5)
Work Plan and Target:
GHWP_TC_WG04_Work Plan 2012-2014
GHWP_TC_WG06_Work Plan 2012-2014