Quality and Regulatory Conference
The 7th Edition of Regulatory Lecture: Practice for Product Compliance and Market Launch
Sep.2,2026|Conference Room E of Hall N4
Medical Device Industry Conference
Conference Agenda
09:50-10:00
Moderator Remarks
10:00-10:30
US FDA: Maintaining Regulatory Momentum in a Changing World
Mr. Wil Vargas, Public Health Advisor, FDA China Office
Mr. Wil Vargas, Public Health Advisor, FDA China Office
10:30-11:00
Latest Developments of EU MDR Regulations in 2026
Gert Bos PhD, Partner & Chief Scientific Officer (CSO), Qserve
Gert Bos PhD, Partner & Chief Scientific Officer (CSO), Qserve
11:00-11:30
Main Changes in the New Version of IS010993-1 and Biocompatibility Evaluation Strategies
Bill Xu, Director of Preclinical Safety Evaluation, Pharmaron Medical Devices
Bill Xu, Director of Preclinical Safety Evaluation, Pharmaron Medical Devices
11:30-12:00
Implementation of Unique Device Identification (UDI) for Medical Devices and the GS1 Standards System
Su Xiaocui, Supervisor, Healthcare Application Promotion,Application Promotion Department, Article Numbering Center of China(ANCC)
Su Xiaocui, Supervisor, Healthcare Application Promotion,Application Promotion Department, Article Numbering Center of China(ANCC)
12:00-12:50
Lunch & Exhibition
12:50-13:00
Moderator Remarks
13:00-13:30
Key Considerations and Design Essentials for Preclinical Animal Studies of Brain-Computer Interface Medical Devices
Zhao Jinchuan, Director of Clinical Trial Center, Dongdian(Hangzhou) Medical Technology Co., Ltd.
Zhao Jinchuan, Director of Clinical Trial Center, Dongdian(Hangzhou) Medical Technology Co., Ltd.
13:30-14:00
CMR and EDC Compliance under the EUMDR: Regulatory Requirements, Risk Assessment and Testing Strategies
Yang Zhijun, Technical Manager, SGS
Yang Zhijun, Technical Manager, SGS
14:00-14:30
Regulatory landscape in EU, updates and important timelines, Notified Body perspective on IVDR
Mikko Soikkeli, Managing Director at Sertio Oy (a Kiwa company)
Mikko Soikkeli, Managing Director at Sertio Oy (a Kiwa company)
14:30-15:00
Market Access for Medical Devices in Singapore, Thailand and Vietnam
Jason Zhou, Regulatory Manager, EPINTEK Medical Device CRO and Testing Center
Jason Zhou, Regulatory Manager, EPINTEK Medical Device CRO and Testing Center
15:00-15:30
Medical Device Registration Application and Biocompatibility Assessment
Feng Yan, Technical Director, Medical Device Division, WEIPU Group
Feng Yan, Technical Director, Medical Device Division, WEIPU Group
15:30-16:00
Preclinical Animal Testing Strategies for Medical Devices and BCI Case Sharing
Yuan Hongjiang, General Manager of PharmaLegacy Diagnostic Laboratories(Shanghai) Co., Ltd.
Yuan Hongjiang, General Manager of PharmaLegacy Diagnostic Laboratories(Shanghai) Co., Ltd.
16:00-16:10
Conference Close