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2023 China NMPA Bluebook is here:

Developments in Clinical Pathways for NMPA (CFDA) Submission

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  • Create Date December 2, 2019
  • Last Updated January 30, 2023

Developments in Clinical Pathways for NMPA (CFDA) Submission

This webinar will cover different clinical pathways and how to decide which pathway to choose to support NMPA (CFDA) medical device/IVD regulatory submission or post market surveillance. In addition to the traditional clinical evaluation report, we will go in-depth on the requirements for overseas clinical data acceptance and real world data/evidence in order to mitigate the clinical trial requirement. We will also cover key considerations on the feasibility and justification of overseas clinical data acceptance.

Finally, attendees will learn about the emerging use of Real World Data (RWD) being piloted in HaiNan, China – a cost-effective and less time-consuming alternative to the traditional clinical trial. Overseas manufacturers can obtain approval for the RWD pilot program through the Hainan provincial NMPA to start using devices in clinical settings prior to national NMPA approval, significantly shortening the time to begin selling devices in China. Don’t miss out on the opportunity to learn more about this new policy! This informative webinar will provide you with:

  • Key factors for China clinical strategy and pathways to support submission
  • Main differences in China CER and EU CER
  • Key factors to consider in using overseas clinical data
  • Updates on the Real World Data pilot program to reduce clinical trial cost and time

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