China’s Regulatory Landscape for Drug-Device Combination Products

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China’s regulatory framework for medical devices continues to evolve. This webinar will explore the regulatory landscape for medical devices in China, with a particular focus on devices used in combination products. It will provide a high-level overview of the regulatory journey from pre-market submission to post-market compliance, highlighting the unique considerations for device components within drug/device combinations. Emphasizing strategic planning and cross-functional collaboration, the session will highlight how manufacturers can align with regulatory expectations and streamline approval processes. The discussion will also touch on emerging regulatory topics, including China’s implementation of GMP and other developments shaping compliance and market access. Designed for industry professionals, this session provides practical insights to support regulatory planning and decision-making in the China market.

Watch this webinar and learn:

  • China’s regulatory pathway for medical devices, including combination products 
  • How to identify key compliance requirements from pre-market submission to post-market activities
  • The role of cross-functional collaboration in regulatory success
  • Insights into emerging topics like GMP implementation and evolving market access trend

Louisa Meng

Sr. Senior Regulatory Affairs Specialist

With a strong focus on regulatory affairs in China and the APAC region, Louisa has extensive experience in the medical device industry. She develops strategies and supports pre- and post-marketing activities to ensure compliance throughout the product lifecycle. She holds a Master of Biomedical Innovation & Development from Georgia Tech.