WG1 Pre-Market Submission and CSDT | ||
|---|---|---|
| Acting Chair: | Ms. Hye-Kyung Son Email: mild1763@korea.kr | Regulatory Authority |
| Co-Chair: | Ms. Mandy Myoung Shim Kim Email: mkim65@its.jnj.com | Industry |
| Advisor: | Dr. Arthur Brandwood Principal Consultant Brandwood Biomedical Australia | Industry |
| Advisor: | Mr. Edward Woo RA Lead Asia Pacific & India Sub-Continent Philips Hong Kong SAR | Industry |
| WG 1 Secretary: | Ms. Yesong PARK Sr. RA Specialist Johnson & Johnson Medical Republic of Korea | Industry |
| Member: | Mr. Alamri Mesha'l Executive Director Premarket & Scientific Evaluation Management Medical Devices Sector Saudi Food & Drug Authority Kingdom of Saudi Arabia | Regulatory Authority |
| Member: | Mr. Gulnar Berkimbayeva Head of Department of Primary Expertise Medical Devices National Center Kazakhstan | Regulatory Authority |
| Member: | Mr. Fikrisyah Bin Irman Medical Device Evaluator, Directorate of Medical Device and Household Health Product Evaluation Ministry of Health Indonesia | Regulatory Authority |
| Member: | Ms. Sookyeong Shin Department of Medical Device Evaluation Ministry of Food & Drug Safety Republic of Korea | Regulatory Authority |
| Member: | Dr. Felista Chepwogen Head of medical devices and diagnostics department National Medicines Regulation Officer Kenya | Regulatory Authority |
| Member: | Ms. Faiza Said AL Zadjali Eng Director of Medical Device Control DGPA & DC Ministry of Health Sultanate of Oman Sultanate of Oman | Regulatory Authority |
| Member: | Ms. Hanadi Alousaimi Senior Scientific Evaluation Specialist Saudi Food and Drug Authority Kingdom of Saudi Arabia | Regulatory Authority |
| Member: | Mr. Shiqing Zhang Deputy Director of Quality Management Department Center for Medical Device Evaluation People's Republic of China | Regulatory Authority |
| Member: | Eng. Sahar Almalki Scientific Evaluation Expert Saudi Food and Drug Authority Kingdom of Saudi Arabia | Regulatory Authority |
| Member: | Ms. Jie Li Reviewer Center For Medical Device Evaluation, NMPA 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: | Ms. Ming Hao Tan Manager Regulatory Associates LLP Singapore | Industry |
| Member: | Mr. Grant Bennet Director & CEO Brandwood Biomedical People's Republic of China | Industry |
| Member: | Ms. Minghua Chen Business Development Manager Asia-Pacific, Senior Consultant Qserve Group China Ltd People's Republic of China | Industry |
| Member: | Ms. Sheryl Hsiao Regulatory Affairs and Compliance Asia Manager 3M Singapore | Industry |
| Member: | Mr. Pavan Kumar Malwade Deputy General Manager Quality & Regulatory Affairs Siemens Healthineers India LLP India | Industry |
| Member: | Ms. Victoria Qu Director, Regulatory Affairs Abbott Laboratories People's Republic of China | Industry |
| Member: | Mr. Sanoj Prabhakaran Regulatory Affairs Manager, Middle East, North Africa & Turkey, where Oman, UAE and Saudi Arabia Becton Dickinson Kingdom of Saudi Arabia | Industry |
| Member: | Mr. NG Swee Choong Sr. Engineer Cook Asia Limited Hong Kong SAR | Industry |
| Member: | Mr. Tony Yip Associate Director, Regulatory Affairs, Asia Pacific Grifols (HK) Limited Hong Kong SAR | Industry |
| Member: | Ms. Chiew Teng Chuah Manager, EHS & Regulatory 3M Malaysia Sdn Bhd Malaysia | Industry |
| Member: | Mr. Edward Woo Sr. Dir. RA, Asia Pacific Varian Medical Systems Pacific, Inc. Hong Kong SAR | Industry |
| Member: | Ms. Yusyanti Mat Tahir Manager, Regulatory Affairs Becton Dickinson Singapore | Industry |
| Member: | Ms. Youngsoon Jeon Sr. RA/QA/Reimbursement Manager, RA/QA/RIP Department Bard Korea Ltd. Republic of Korea | Industry |
| Member: | Mr. Youngsoo Seol QMR ILOODA CO., LTD. Republic of Korea | Industry |
| Member: | Mr. Kulveen Bali Singh Manager - Regulatory Affairs 3M India Limited India | Industry |
| Member: | Dr. Henry Hou Regulatory Affairs Manager Elekta Limited Hong Kong SAR | Industry |
| Member: | Mr. Asok Kumar Director Global Strategic Regulatory Affairs Abbott Laboratories India | Industry |
| Member: | Ms. Jyotsna Yadav Sr. Manager Smith & Nephew Dubai, UAE | Industry |
| Member: | Ms. Yesong PARK Sr. RA Specialist Johnson & Johnson Medical Republic of Korea | Industry |
| Member: | Mr Sharad Manasvi Shukla Director Regulatory Affairs, MedTech Johnson & Johnson Medical Singapore | Industry |
| Member: | Mr. Inho Dan Sr. Quality and Regulatory Affairs Manager - ANZ, Emerging Asia and Korea Cordis Korea Ltd Republic of Korea | Industry |
| Member: | Ms. Qiong Wu RA Director Johnson and Johnson Medical (Shanghai) Ltd People's Republic of China | Industry |
| Member: | Ms. Hana Lee RA Manager Mindray Korea Republic of Korea | Industry |
| Member: | Ms. Jean Lei Regulatory Affairs Manager Shenzhen Mindray Biomedical Electroics Co. Ltd People's Republic of China | Industry |
| Member: | Ms. Jing Crystal Nie Director Regulatory Affairs & Regulatory Compliance (China) MicroVention Inc.,subsidiary of Terumo Corporation People's Republic of China | Industry |
| Member: | Dr. Huiying LI Associate RA Director Medtronic People's Republic of China | Industry |
| Member: | Ms. Fang LYU Sr. RA Director Medtronic Greater China People's Republic of China | Industry |
| Member: | Mr. Hirokazu Fukuda Member of Regulatory Affairs Group FUJIFILM Healthcare Corporation Japan | Industry |
| Member: | Mr. Tao Wu Prin. RAS Medtronic (Shanghai) Management Co., Ltd People's Republic of China | Industry |
| Member: | Ms. Kazuko Ueki Associate Director, Regulatory Affairs, Asia Pacific Johnson & Johnson K.K. Japan | Industry |
| Member: | Ms. Makiko Kuroki Assistant Manager Asahi Kasei Medical Co., Ltd. Japan | Industry |
| Member: | Ms. Tiffany Lin QA/RA Manager UROMEDTECH PTE LTD Singapore | Industry |
| Member: | Ms. Wella Wei China RAQA Director Align Technology Co. Ltd. People's Republic of China | Industry |
| Member: | Dr. Yassmin Eltalawi Regulatory Intelligence Manger - EMEA Becton Dickinson Dubai-UAE | Industry |
| Member: | Mr. Chidae Park HQ Regulatory Affairs Managing Director Lutronic Corpation Republic of Korea | Industry |
| Member: | Ms. Sin Yi Chong Regulatory Affairs Executive Osteopore International Pte Ltd Singapore | Industry |
| Member: | Ms. Heli Liu Regulatory Affairs and Quality Assurance, Senior Director, APAC Align Technology People's Republic of China | Industry |
| Member: | Ms. Jie Jiang Executive of Regulatory & Regional Quality GE Healthcaer People's Republic of China | Industry |
| Member: | Ms. Liyun Gao Senior Regulatory Affairs Manager Becton, Dickinson and Company People's Republic of China | Industry |
| Member: | Ms. Lei Wu Sr. RA Manager Venus Medteach (Hangzhou) Inc. People's Republic of China | Industry |
| Member: | Dr. Xiaowei Sun Head of Regulatory Affairs, Greater China Philips People's Republic of China | Industry |
| Member: | Ms. Heejin Choi Regulatory Affairs Manager, Country 3M Healthcare Korea Republic of Korea | Industry |
| Member: | Ms. Ji Yeon Kim RA & QA Director Stryker East Asia Republic of Korea | Industry |
| Member: | Ms. Nisa Nopporn Associate Regulatory Affairs Manager Becton Dickinson Thailand Limited Thailand | Industry |
| Observer: | Dr. Peter W.J. Linders Director, Standards & Regulations, Global Quality & Regulatory Philips Healthcare The Netherlands | Industry |
| Observer: | Mr. Keiichiro Ozawa Regulatory Specialist, Medical Device FUJIFILM Corporation Japan | Industry |