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Webinar on January 17, 2018: How to Get IVD Approval Through CFDA


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Learn Key CFDA Premarket Submission Tips for IVD Approval

Registration is closed for the webinar Wednesday, Jan. 17, 2018 · 1:30 p.m. – 3:00 p.m. EST

Marketing medical devices and IVD into Asia is getting more complicated for innovating companies outside of China. The China FDA (CFDA) has changed the rules significantly on IVDs, and further changes are expected in early 2018. Remember too, most IVDs require clinical trials in China. (They’re clinically exempt in the U.S. and the E.U.)

FDAnews has invited China FDA expert Grace Fu Palma to demystify the process. Her 90-minute presentation is a must for the medical device and IVD community wanting access and opportunity in China’s booming IVD market (experiencing 20% growth year after year!).

What’s covered in this 90 minute presentation:

  • CFDA IVD registration requirements and how they differ from FDA classifications
  • How to prepare samples to pass local IVD approval tests
  • Differences in motivation and criteria between U.S. and China IVD regulatory schemes
  • Changes in the clinical trial exemption catalog
  • Changes in CFDA #650 medical device supervision and monitoring in regard to registration of legal agents
  • And much more!

China’s regulators publishing new guidelines for 2018:

  • Clinical trial exempt list catalog was released on Oct. 30, 2017
  • Clinical trial exempt IVD CER requirements if not clinical trial were promulgated Nov. 8, 2017
  • Medical device supervision and monitoring (#650) registration legal agent status is expected to be changed soon

Success in the fast-growing China IVD market depends upon a clear understanding of how China plans to regulate IVDs as regulations are also changing. This webinar will help you protect your  company’s competitive edge.

Who Is This Webinar Ideal For:

  • Quality Managers of IVD manufacturers
  • Lab Directors who use ASRs
  • Lab Directors who perform High Complexity Testing under the CLIA regulations
  • Regulatory Managers of IVD manufacturers
  • Sales Managers of IVD manufacturers
  • Compliance Managers of IVD manufacturers
  • Compliance Managers of High Complexity labs

Registration is closed for the webinar. Questions before the webinar? Contact us at

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