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Securing Regulatory Approval for IVDs in China

With a population of 1.2 billion people and growing, China has emerged as a major consumer of healthcare products and one of the most lucrative markets for medical devices and IVD products. Following several years of double-digit growth, recent estimates put the value of the Chinese IVD market in the range of 1.5 billion dollars. However, entering the Chinese market requires no small amount of forethought and planning.


This audio conference will discuss the latest organizational chart for the key departments in the SFDA, as announced September 2008, and give insight into hot topics and trends affecting the Chinese healthcare system.


This audio conference will cover:


  • Opportunities in China's healthcare market
  • An overview of China's regulatory system for medical devices and IVD products
  • How to register your IVD in China
  • What you need to know to help your company prepare for future sales in China
  • Key elements to successful registration and what to expect


About the speaker:


Janice Ma is the Managing Director of ChinaGate, and has over 10 years of experience in the health regulatory industry in China. She has provided registration services to over 200 companies, helping them obtain approvals from the State Food and Drug Administration. In this audio conference, attendees will receive the benefit of her insight and expertise as she presents live from Shanghai.


Who should attend?


  • Senior Management at IVD Companies
  • Regulatory Affairs Professionals
  • Marketing Managers
  • Business Development Managers
  • Venture Capitalists and Foreign Investors


Continuing Education


  • This event may be eligible for continuing education credit. For more information please contact us at acsupport@fxtrans.com


*Please note: Each registration covers one line connected to the audio conference. Attendees dialing from separate locations are required to have separate registrations.


ForeignExchange Translations provides specialized Chinese translation services to medical device and pharmaceutical companies.

Speaker & Time

Janice Ma, ChinaGate
Securing Regulatory Approval for IVDs in China
Title: Managing Director
Other Events: Janice Ma, ChinaGate
Event Type: Previously recorded on 2009-02-19
Item #: ac20090219
19 Feb 2009 
Registration Price:
$249.00

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