| Chair: |
Mrs. CHEN Yan |
Regulatory Authority |
Co-Chair: |
Mr. Ee Bin Liew Owner and consultant Access-2-Healthcare Singapore |
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. 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. 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 Business Development Manager BSI Product Service Malaysia |
Industry |
| Member: | Ms. Yean Ting Ong Johnson & Johnson Medical Malaysia |
Industry |
| Member: | Mr. Sateesh Yelisetti Baxter Singapore |
Industry |
| Member: | Mr. Jing Nie Regulatory Manager Johnson & Johnson Medical AP NPD&NBD Johnson & Johnson Medical (Shanghai) Ltd. China |
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 |
Guidance Documents:
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