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
Interpretation of the Latest Updates to FDA Regulatory Policies
FDA China Office (Reserved)
FDA China Office (Reserved)
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
Latest Standards of Toxicology Testing (ISO 10993) and Breakthroughs in Implementation Challenges
Pharmaron (Reserved)
Pharmaron (Reserved)
11:30-12:00
Implementation of Unique Device Identification (UDI) and Establishment of a Comprehensive Traceability System
Huang Zexia, China Article Numbering Center Reserved)
Huang Zexia, China Article Numbering Center Reserved)
12:00-13:20
Lunch & Exhibition
13:20-13:30
Moderator Remarks
13:30-14:00
Innovation in Particulate Contamination Detection Technology and Regulatory Compliance Practices
14:00-14:30
Regulatory Strategy and Risk Management under the Integrated CRDMO/CTDMO Model
14:30-15:00
Synergistic Multi-Market Registration Strategy and Case Studies for China, US, and EU Markets
15:00-15:30
Streamlining Innovative Medical Device Registration Pathways and Clinical Evaluation Approaches
15:30-16:00
Regulatory Framework and Compliance Essentials for Al Medical Devices
16:00-16:10
Conference Close