How to Get IVD Approval Through CFDA - Webinar Recording/Transcript

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How to Get IVD Approval Through CFDA: Key Premarket Submission Tips

Marketing into Asia just got more complicated for device and IVD makers. The China FDA (CFDA) has changed the rules significantly on IVDs, and further changes are expected. Plus, lest you forget, 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 bring you up to speed. Her 90-minute presentation is a must for the medical device and IVD community wanting a piece of China’s booming IVD market (20% growth year after year!). Prepare to dig deep into these key topics:

  • 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!

That’s a lot of ground to cover in just 90 minutes. China’s regulators have been busy:

  • 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 booming China IVD market requires a thorough understanding of how that nation regulates IVDs and how those regulations are changing. This webinar can help protect your competitive edge.

  • 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

Grace Fu Palma, CEO of China Med Device LLC, specializes in helping device and IVD makers market to China via a deeper understanding of that nation’s device regulatory maze. With 20+ years of experience under her belt with both large multinationals and startups, she is ideally positioned to assist with market assessment, premarket approvals, legal representation, clinical evaluation, clinical trials and distribution management in China. Her firm maintains offices in Boston and Beijing, where she grew up. She received her BA from Peking University and earned an MBA at Yale.