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How to Get IVD Approval Through CFDA

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  • File Size 22.27 MB
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  • Create Date February 27, 2018
  • Last Updated January 6, 2022

How to Get IVD Approval Through CFDA

CFDA Regulatory Changes 2017

China medical device/IVD regulations are complex.

IVD related CFDA regulations have gone through significant changes and there are more to come in 2018. The classification rules, regulation category and clinical requirements of CFDA are very different FDA. During this webinar Grace will discuss the key factors that will impact your IVD registration success as well as the IVD development trend in China.

After this 90-minute webinar you will have a practical understanding of the following areas:

  • Latest key updates of IVD regulations, guidelines, and standards in 2017
  • Specific IVD classification rules and registration unit division
  • Significant requirements that you need to compliant for your type testing success
  • Newest China GCP requirements for your IVD clinical trial and CER
  • Different registration pathway and according timeline for IVD registration
  • Complete Registration dossier requirements and best practices

Attached Files

01-17-18-How to Get IVD Approval Through CFDA.mp4Download