| Chair: |
Mr. Chun-Jen Chien Email: i64901037@fda.gov.tw |
Regulatory Authority |
| Co-Chair: |
Mr. Tony YIP Email: tony.yip@grifols.com |
Industry |
| Advisor: | Dr. Ir Peter W. J. Linders Director, Global Regulations & Standards Philips Netherlands |
Industry |
| Advisor: | Dr. Koen Cobbaert Senior Manager - Quality, Standards & Regulations Global Regulations and Standards Philips Netherlands |
Industry |
| Secretary | Dr. Tailor Tai-Long Chen Reviewer Food and Drug Administration Ministry of Health and Welfare Chinese Taipei |
Regulatory Authority |
| Member: | Ms. Elisa PRITHA Medical Device Evaluator Ministry of Health Republic of Indonesia |
Regulatory Authority |
| Member: | Ms. Young-min Han Assistant Director Ministry of Food and Drug Safety Republic of Korea |
Regulatory Authority |
| Member: | Ms. Marwa AL SHEHEIMI Section Head Low Risk Registration Section Ministry of Health Sultanate of Oman |
Regulatory Authority |
| Member: | Ms. Zahra AL-HOOTI Biomedical Engineer High Risk Registration Section Ministry of Health Sultanate of Oman |
Regulatory Authority |
| Member: | Ms. Anindita SAHA Assistant Director Digital Health Center of Excellence US Food and Drug Administration United States of America |
Regulatory Authority |
| Member: | Mr. Wil VARGAS General Engineer Digital Health Center of Excellence US Food and Drug Administration United States of America |
Regulatory Authority |
| Member: | Mr. Chih-Chung Chien Officer Food and Drug Administration Ministry of Health and Welfare Chinese Taipei |
Regulatory Authority |
| Member: | Dr. Liang PENG Deputy Division Director Center for Medical Device Evaluation of NMPA People's Republic of China |
Regulatory Authority |
| Member: | Mr. Hong LIANG Reviewer Center for Medical Device Evaluation of NMPA People's Republic of China |
Regulatory Authority |
| Member: | Dr. Hala ALHODAIB Senior Scientific Evaluation Expert Saudi Food & Drug Authority Kingdom of Saudi Arabia |
Regulatory Authority |
| Member: | Mr. Yazid ALAZWARI Head of New Technologies Assessment Saudi Food & Drug Authority Kingdom of Saudi Arabia |
Regulatory Authority |
| Member: | Mr. Mohammed ALAMER Radiation Safety and Protection Standards Designated Head Section Saudi Food and Drug Authority Saudi Arabia |
Regulatory Authority |
| Member: | Dr. Wenbo Liu Reviewer Center for Medical Device Evaluation of NMPA People's Republic of China |
Regulatory Authority |
| Member: | Mr. Ce Yang Reviewer Center for Medical Device Evaluation of NMPA People's Republic of China |
Regulatory Authority |
| Member: | Prof. Chenxi Wang Senior Engineer, Division of Active Medical Devices and Medical Optics, Institute for Medical Devices Control, National Institutes for Food and Drug Control People's Republic of China |
Regulatory Authority |
| Member: | Dr. Lindsay TAO Corporate Director Global Health Policy Johnson & Johnson |
Industry |
| Member: | Mr. John BABY Managing Director Quality Systems and Solutions Pte Ltd Singapore |
Industry |
| Member: | Mr. Kelvin Hong Yap KOH Director APAC Regulatory Affairs Terumo BCT Asia Pte Ltd. Singapore |
Industry |
| Member: |
Ms. Jacqueline Monteiro |
Industry |
| Member: | Ms. Lesley TEE Assistant Manager, Quality and Regulatory Philips Electronics Singapore Pte Ltd Singapore |
Industry |
| Member: | Mr. Sundeep Agarwal General Manager Datt Mediproducts PVT. Limited India |
Industry |
| Member: | Ms. Shing Koon CHENG Regulatroy Affairs Manager Boston Scientific Asia Pacific Pte Ltd Singapore |
Industry |
| Member: | Ms. Young Jin LEE Senior Manager, Quality & Regulatory Philips Republic of Korea |
Industry |
| Member: | Mr. Wonbin KIM General Manager VATECH Co., Ltd. Republic of Korea |
Industry |
| Member: | Dr. Hun Shim Associate Researcher Wonju Medical Insstry Technovalley Republic of Korea |
Industry |
| Member: | Dr. Duc Duong-Hong Regulatory Affairs Manager,SEA Edwards Lifesciences (ASIS) Pte. Ltd. Singapore |
Industry |
| Member: | Mr. Pavan Kumar Malwade Deputy General Manager Quality & Regulatory Affairs Siemens Healthineers India LLP India |
Industry |
| Member: | Dr. Ganesh Babu Head Clinical & Regulatory Affairs Carl Zeiss India (Bangalore) Pvt Ltd |
Industry |
| Member: | Dr. Sheng-Hui LIAO Engineer Industrial Technology Research Institute Chinese Taipei |
Industry |
| Member: |
Ms. Jin CUI |
Industry |
| Member: | Ms. Yasha HUANG Head of Regulatory Policy, APAC Roche Singapore |
Industry |
| Member: | Mr. Sharad Manasvi Shukla Director Regulatory Affairs, MedTech, Johnson & Johnson Singapore |
Industry |
| Member: | Mr. Qin Chuan Senior regulatory affairs manager-digital healthcare GE Healthcare China People's Republic of China |
Industry |
| Member: | Mr. Pat Baird Senior Regulatory Specialist Philips United States of America |
Industry |
| Member: | Ms. LanLan (Lannice) Wu Quality Assurance & Regulatory Affairs Senior Vice President Hanalytics Pte. Ltd. Singapore |
Industry |
| Member: | Mr. Winson Teng Global Regulatory Affairs Intelligence Manager Becton Dickinson and Company Singapore |
Industry |
| Member: | Mr. Ting-Han CHIEN Section Chief Center for Drug Evaluation Chinese Taipei |
Industry |
| Member: | Ms. Weijie XIA Regulatory Affairs Manager Medtronic People's Republic of China |
Industry |
| Member: | Ms. Youngchan Cho (Elly) RA & CA manager Philips Republic of Korea |
Industry |
| Member: | Ms. Qian Dong Head of Regulatory Intelligence, APAC, Align Technology People's Republic of China |
Industry |
| Member: | Mr. Hideki Asai Senior Fellow MED MIRAI Inc. Japan |
Industry |
| Member: | Ms. Wendy (Chiao-Wen) Shen Head of Regulatory Affairs Johnson & Johnson Medical Taiwan Ltd. Chinese Taipei |
Industry |
| Member: | Ms. Huang Valerie Assistant Manager, Regulatory Affairs, APAC Terumo Asia Pte Ltd Singapore |
Industry |
| Member: | Ms. Wang Rong QARA & HEPR VP Medtronic Greater China People's Republic of China |
Industry |
| Member: | Dr. Lei Wang Director of Imaging AI Siemens Shanghai Medical Equipment Ltd. People's Republic of China |
Industry |
| Member: | Ms. Wella Wei China RAQA Director Align Technology Co. Ltd. People's Republic of China |
Industry |
Guidance Documents:
FINAL_GHWP-WG3-SaMD-002_Risk Categorisation of SaMD Final (2) SR