WG5 Clinical Evidence for Performance and Safety

WG5 Clinical Evidence for Performance and Safety
Chair:	Ms. Aidahwaty M. Olaybal Director Director of Pre-market Control Division MDA, Malaysia Email: aidahwaty@mda.gov.my	Regulatory Authority
Co-Chair:	Ms. Ong Yean Ting Head Quality and Regulatory Roche Diagnostics Malaysia Sdn Bhd Email: yean_ting.ong@roche.com	Industry
Secretary:	Ms. Mie Ohama Compliance Manager, Audit Management GQC Quality and Enterprise Learning PPD Australia	Industry
Advisor:	Dr. A. Devitt Martin Managing Director Lifecycle Medical Australia	Industry
Member:	Mr. SIU Hiu Fai Stanley Engineer Electrical and Mechanical Services Department Government of the Hong Kong Special Administrative Region Hong Kong SAR, China	Regulatory Authority
Member:	Dr. Rongzhi Liu Reviewer of Clinical Evaluation and Biostatistics Division II Center for Medical Device Evaluation (CMDE) of NMPA People's Republic of China	Regulatory Authority
Member:	Ms. Li FANG Reviewer of Clinical Evaluation and Biostatistics Division II Center for Medical Device Evaluation (CMDE) of NMPA People's Republic of China	Regulatory Authority
Member:	Ms. Shan JU Technical Reviewer Center for Medical Device Evaluation (CMDE) of NMPA People's Republic of China	Regulatory Authority
Member:	Mr. Christian Natalis Kapinga Medical Devices Officer Tanzania Medicines and Medical Devices Authority Tanzania	Regulatory Authority
Member:	Dr. Jai-Yen Chen Section Chief Center For Drug Evaluation Chinese Taipei	Regulatory Authority
Member:	Ms. Asma Zuberi Senior Regulatory Affairs Specialist Gulf & Pakistan Baxter A.G Scientific Office	Industry
Member:	Mr. Justin YOO Professor & Head Dongguk University & A bio Medical Venture Firm Republic of Korea	Industry
Member:	Ms. Amber Wang VP, Regulatory Affairs and Quality Assurance, Genesis MedTech Group People's Republic of China	Industry
Member:	Ms. Yi Gu Associate Director, Regulatory Affairs, Johnson & Johnson Medical Shanghai People's Republic of China	Industry
Member:	Ms. Linmeng Dong Senior Regulatory Affairs Manager Medtronic People's Republic of China	Industry
Member:	Mr. Wei Zhang Sr. Clinical Trial Manager Siemens Healthineers Diagnostics (Shanghai) Co., Ltd. People's Republic of China	Industry
Member:	Ms. Li Zhang Sr. Clinical Manager Siemens Healthineers People's Republic of China	Industry
Member:	Ms. Qiuyun Zhao Senior Regulatory Affairs Specialist Elekta Beijing Medical Systems Co. Ltd. People's Republic of China	Industry
Member:	Dr. Michael Lee Head of Cardiology Queen Elizabeth Hospital Hong Kong SAR, China	Others