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TC Office Bearers, Working Groups
TC Office Bearers
TC Chair
Ms. Jun Li
Deputy Director, Center for Medical Device Evaluation, NMPA, China
TC Co-Chair (Regulatory Authority)
Ms. Aidahwaty M. Olaybal
Senior Director, Pre-Market Control Division, Medical Device Authority, Ministry of Health, Malaysia
TC Co-Chair (Regulatory Authority)
Dr. Rania Soliman
General Manager of General Administration of Medical Devices Marketing Authorization, Central Administration of Medical Devices, Egyptian Drug Authority, Egypt
TC Co-Chair (Industry)
Mr. Tony Yip
Associate Director Regulatory Affairs, Asia Pacific, Grifols (HK) Limited
TC Co-Chair (Industry)
Ms. Yasha Huang
Head of Regulatory Policy, APAC, Roche Diagnostics, Singapore
TC Secretaries:
Dr. Adelheid Schneider
Consultant Regulatory Affairs and Quality
Coach and Mentor
Ms. Victoria Qu
Sr. Director, QARA, Cytiva China
Danaher
Ms. Yinghui Gao
Policy & Regulation Director
Johnson & Johnson Medtech China
Working Groups (WGs)
WG1 Pre-Market Submission and CSDT
WG2 Pre-Market: IVDD
WG3 Pre-Market: Software as a Medical Device
WG4 Post-Market
WG5 Clinical Evidence for Performance and Safety
WG7 Quality Management System
WG8 Standards
WG9 UDI & Nomenclature
Special Task Group (STG) - Common Evaluation Reliance Practice (CERP)
