How to Get IVD Approval Through NMPA (CFDA)

How to Get IVD Approval Through NMPA (CFDA)

How to Get IVD Approval Through NMPA (CFDA)

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  • February 27, 2019 Create Date
  • June 18, 2020 Last Updated
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NMPA (CFDA) Regulatory Changes 2017

China medical device/IVD regulations are complex.

IVD related NMPA (CFDA) regulations have gone through significant changes and there are more to come in 2018. The classification rules, regulation category and clinical requirements of NMPA (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
Illustration of a laptop computer showing Grace Fu Palma speaking during a presentation for a webinar

01-17-18-How to Get IVD Approval Through CFDA.mp4