TC Office Bearers, Working Groups

TC Office Bearers

TC Chair

Dr. Mohammed Majrashi

Executive Director, Surveillance and Biometric, Saudi Food & Drug Authority (SFDA), Kingdom of Saudi Arabia

TC Co-Chair
(Regulatory Authority)

Ms. LI Jun

Deputy Director, Center for Medical Device Evaluation, National Medical Products Administration (NMPA), China

TC Co-Chair
(Industry)

Ms. Miang Tanakasemsub

Head of Regulatory Affairs (RA), Asia Pacific (AP), Johnson & Johnson Vision

TC Secretaries:	Dr. Adelheid Schneider Consultant Regulatory Affairs and Quality Coach and Mentor
Ms. Victoria Qu Director, Quality and Regulatory Affairs Asia Pacific, Cordis
Ms. Yasha Huang Head of Regulatory Policy Asia Pacific, Global Regulatory Policy & Intelligence, Roche Diagnostics Asia Pacific Pte Ltd
Ms. Yinghui Gao Policy & Regulation Director Johnson & Johnson Medtech China

TC Secretaries:

Dr. Adelheid Schneider
Consultant Regulatory Affairs and Quality
Coach and Mentor

Ms. Victoria Qu
Director, Quality and Regulatory Affairs
Asia Pacific, Cordis

Ms. Yasha Huang
Head of Regulatory Policy Asia Pacific, Global Regulatory Policy & Intelligence, Roche Diagnostics Asia Pacific Pte Ltd

Ms. Yinghui Gao
Policy & Regulation Director
Johnson & Johnson Medtech China

TC Office Bearers, Working Groups

TC Office Bearers

TC Chair

Dr. Mohammed Majrashi

TC Co-Chair
(Regulatory Authority)

Ms. LI Jun

TC Co-Chair
(Industry)

Ms. Miang Tanakasemsub

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)

TC Office Bearers, Working Groups

TC Office Bearers

TC Chair

Dr. Mohammed Majrashi

TC Co-Chair(Regulatory Authority)

Ms. LI Jun

TC Co-Chair(Industry)

Ms. Miang Tanakasemsub

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)

TC Co-Chair
(Regulatory Authority)

TC Co-Chair
(Industry)