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Securing Regulatory Approval In China

December 11, 2018 to December 12, 2018
Washington, DC
Global
Workshop

VIEW THE AGENDA HERE

The medtech industry is one of the key industries in China, where the market demands for high value medical devices have been increasing.  The government constantly adjust the regulatory requirements and process to encourage local R&D and manufacturing so as to reduce the country’s dependence heavily on imported high value medical equipment and products. Multinational companies have been adopting new regulatory strategies and exploring new business models in response to this policy and the evolving healthcare reform in China. In the meantime, they are constantly challenged by the regulatory constraints, policy changes and government enforcements in different subject areas.

This course will cover CMDE/CFDA's perspective on regulatory requirements and process for different types of submissions (initial application, registration change and renewal), as well as post market compliance. In this program, industry experts will provide an in-depth guide to how you as an organization can secure regulatory approval in the China market.

Closely paralleling the topics covered during AdvaMed's 510(k) and PMA Submission Strategy Workshops, the China Workshop 2018 will include a lot of development and updates based on the topics of the workshop 2017.  You will walk away with actionable insights and strategies for assembling and streamlining your submissions for the largest emerging market in the world.

Agenda topics will include:

  • The law & regulations and government restructure
  • Strategy and planning, adopting new regulatory changes
  • Clinical trial or evaluation requirement
  • Type testing requirement and reform
  • CMDE/CFDA review process
  • Discussion and experience sharing
  • Post-market compliance

Speakers:

  • Bruce Fu, Director, Greater China Technology Practice, APCO Worldwide
  • Davey Han, Founder & CEO, BioHan Biotechnology
  • Susan Xue, China Regulatory Affairs Consultant
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Summary | 2 Annotations
CFDA's perspective on regulatory requirements and process for different types of submissions (initial application, registration change and renewal), as well as post market compliance. In this program, industry experts will provide an in-depth guide to how you as an organization can secure regulatory approval in the China market.
2018/12/06 17:10
This course will cover CMDE/CFDA's perspective on regulatory requirements and process for different types of submissions (initial application, registration change and renewal), as well as post market compliance. In this program, industry experts will provide an in-depth guide to how you as an organization can secure regulatory approval in the China market.
2018/12/06 17:11