Special Task Group (STG)-Common Evaluation Reliance Practice (CERP)

Special Task Group (STG)-Common Evaluation Reliance Practice (CERP)

Acting Chair:

Dr. Shiqing Zhang
Director of Quality Management Department
Center for Medical Device Evaluation of NMPA
People's Republic of China

Email: zhangsq@cmde.org.cn

Regulatory Authority
Acting Co-Chair:

Ms. Asmaa Awad
Global Regulatory Policy Lead EE, ME& Africa
Roche Diagnostics
Middle East Dubai, United Arab Emirates

Email: asmaa.awad@roche.com

Industry
Advisor:

Ms. Li Zhang
Lead for China
APACMed
People's Republic of China

Industry
Advisor: Mr. Naoki Morooka
Senior General Manager, Medical Regulatory Policy Department
Shimadzu Corporation
Japan
Industry
Member: Mr. Ishibashi Kenichi 
Senior Scientist
Pharmaceuticals and Medical Devices Agency
Japan
Regulatory Authority
Member: Dr. Yokoyama Yoshimasa
Principal Reviewer
Pharmaceuticals and Medical Devices Agency (PMDA)
Japan
Regulatory Authority
Member: Ms. Aidahwaty M. Olaybal
Director, Pre-Market Control
Medical Device Authority, Ministry of Health
Malaysia
Regulatory Authority
Member: Ms. Norlela Hatta Antah
Director, International Affairs and Industry Facilitation Division
Medical Device Authority, Ministry of Health
Malaysia
Regulatory Authority
Member: Ms. Heba Tork
Regulatory & Quality Manager North Africa
Roche Diagnostics
Egypt
Industry
Member: Ms. Bo Gao
Policy and Intelligence Director
Roche
People's Republic of China
Industry
Member: Mr. Inho Dan
Sr. Quality and Regulatory Affairs Manager for ANZ, Korea and SEA
Cordis US Corp

Republic of Korea
Industry
Member: Ms. Jing (Kate) Liu
Director
Bluesail Surgical

People's Republic of China
Industry
Member: Ms. Jing Hu
QT Director
Siemens Shenzhen Magnetic Resonance Ltd.
People's Republic of China
Industry
Member: Ms. Jing Liu
Regulatory Affairs Director
Well Lead Medical Co., Ltd.
People's Republic of China
Industry
Member: Mr. Jiunyan Johnny Wu
Medical device evaluation engineer
Industrial Technology Research Institute, Chinese Taipei
Chinese Taipei
Industry
Member: Mr. Justin Yea
RAQA Sr. Program Manager
Medtronic Korea Ltd.

Republic of Korea
Industry
Member: Ms. Li Li
Senior Regulatory Affairs Director
Medtecx Co. Ltd.
People's Republic of China
Industry
Member: Ms. Liqin Li
Associate Director, Clinical Affair & Regulatory Affair
Stryker (Beijing) Healthcare Product Co.,Ltd
People's Republic of China
Industry
Member: Ms. Nianci Xu
Clinical Evaluation Specialist
Micro-Tech (Nanjing) Co. Ltd.
People's Republic of China
Industry
Member: Ms. Qiuyun Zhao
Senior Regulatory Affairs Specialist
Elekta Beijing Systems Co. Ltd.
People's Republic of China
Industry
Member: Ms. Rui Wang
RA & CA Director
Sino Medical Science Technology Inc.
People's Republic of China
Industry
Member: Ms. Sally Chiu
MDR Executive Secretary
Medtecx Co. Ltd.
Chinese Taipei
Industry
Member: Ms. Tiantian Yang
Regulatory Supervisor
BSC International Medical Trading (Shanghai) Co., Ltd
People's Republic of China
Industry
Member: Mr. Xuelai Wang
CEO
SCW Medicath Ltd
People's Republic of China
Industry
Member: Mr. Yihua Cao
Regulatory Affiars
Asahi Kasei Medical Co., Ltd
Japan
Industry
Member: Mr. Yi-Shin Lee
Vice President
Bioteque Corporation
Chinese Taipei
Industry
Member: Ms. Yujia Guo
Sr. Manager
Cordis (Shanghai) Medical Devices Co., Ltd.
People's Republic of China
Industry