THE WORLD’S FASTEST GROWING MARKET: PREPARING FOR THE REGULATORY OPPORTUNITIES AND CHALLENGES IN CHINA

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