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The World’s Fastest Growing Market: Preparing for the Regulatory Opportunities and Challenges in China
The World’s Fastest Growing Market: Preparing for the Regulatory Opportunities and Challenges in China


 
Our Price: $395.00

Product Code: WB-7193
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About the Product
Includes 50 Minute Windows Media Video File and PowerPoint presentations for immediate download.

China is gradually becoming a competitive force and evolving into the world’s fastest growing market for Medical Devices and In Vitro Diagnostics (IVD) products. By 2018 the Chinese IVD market is expected to be twice its 2013 market size. The China Food and Drug Administration (CFDA) issued multiple final rules and guidances to comply with the State Council revised MDR in March 2014. How do we take the advantage of the new registration processes for different classes new and re-registrations? And how do we get prepared with the new requirements in type testing, clinical trials and labeling, and other areas? Deep understanding of China’s environment and experienced expertise would help regulatory professionals in developing comprehensive regulatory strategies and planning for the global market success. Dr. Min Yue is a recognized global regulatory expert with over twenty years of experience in R&D, regulatory strategies and global submissions in pharmaceuticals, medical devices, and IVDs. Min’s presentation will cover the following topics:
  • China IVD market forecast in the next 5-10 years
  • Regulatory environment for imported and domestic product registrations
  • Overview of the CFDA new regulations/guidances
  • Major impact of the new requirements and processes
  • Opportunities and Challenges


Speaker:
Xin Min (Min) Yue, DVM, MS, RAC
Sr. Staff /Sr. Manager, LS Regulatory Affairs

Beckman Coulter


Participants that will find this webinar most beneficial will be those involved in diagnostics companies. Job titles of attendees that will be most applicable for this session will be:

  • Regulatory Affairs
  • Regulatory Operations

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