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Evaluation ViewAttendees 28

Devices (includes Medical Devices & In Vitro Diagnostics)

Accelerating China Market Access for Medical Devices: Regulatory Shifts, Clinical Leverage & Strategic Insights

Wednesday, October 8, 2025
2:15 PM - 3:15 PM EST
Location/Room: 315
Join a seasoned panel of industry experts as we unpack the latest regulatory and clinical developments shaping medical device access in China. This session will deliver practical strategies to shorten time to market and navigate the evolving landscape with confidence.

We’ll explore:
  • New regulatory guidance and technical standards—what’s changed and how to stay ahead

  • Smarter clinical strategies—how to leverage global clinical evidence to minimize or bypass in-China trials

  • Trends in type testing and lessons learned

  • Winning JV models that align with China’s “Made in China” policy while preserving global quality

  • Foreign inspections and the new draft GMP—what to expect and how to prepare

  • Software, AI, and cybersecurity compliance—navigating China’s tightening oversight on software related requirements


Whether you're entering the China market or scaling your presence, this session will equip you with actionable insights and real-world lessons to accelerate success.

Learning Objectives:

  • This session will explore and explain the recent key regulatory and clinical factors to shorten time to market
  • Learn the best practices and regulatory requirements relating to maintaining registrations and compliance
  • Understand the overview of China regulatory framework and the latest updates