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

50 Minute Video | Xin Min (Min) Yue, Beckman Coulter

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

 

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

Dr. Min Yue is currently working at Beckman Coulter as Manger of Regulatory Affairs supporting global regulatory strategies and submissions in medical devices and in vitro diagnostics (IVD). Min is a recognized global regulatory expert with over twenty years of experience in R&D, regulatory strategies and global submissions in pharmaceuticals, medical devices/IVD and dietary supplements.

Min came to the US twenty-four years ago with a veterinary medicine degree, three years of teaching at veterinarian school, and six years management experience at the Commodity/Food Inspection Bureau (CCIB) in China. Prior to Beckman, Min worked at Eli Lilly for twelve years and PAREXEL for three years in preclinical studies, global clinical strategies and worldwide submissions.


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