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The New Landscape of China Clinical Evaluation: Diversified Pathways to Expedite your Market Approval (Part I)

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  • Create Date February 29, 2024
  • Last Updated March 17, 2024

The New Landscape of China Clinical Evaluation: Diversified Pathways to Expedite your Market Approval (Part I)

Are you struggling to understand the clinical evaluation requirements and how to leverage clinical data for China NMPA submission? This session will take a deep dive into the evolving regulations on clinical evaluation in China. Topics will cover clinical evaluation pathways, decision tree, principles and processes, key factors in clinical evaluation report (CER). The session will also touch upon the real-world data/study (RWS/D) in China pilot zone and discuss when and how to utilize RWD to support submission pre or post marketing could minimize the cost and time to market entry.

  • Understand the framework of clinical evaluation in China: regulations, guidelines and requirements
  • Explore the different pathways of clinical evaluation in China and how to determine the pathway based on the decision tree
  • Discover how the overseas clinical data can be leveraged in more versatile ways to support regulatory approval.
  • Learn how to demonstrate product equivalence and find out the key factors of writing clinical evaluation report (CER)
  • Learn how the Hainan Real-World Data/Study (RWD/Study) pilot program can shave months off your timeline for initial clinical use of NMPA unapproved devices in a real-world setting.

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