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2014 Revision of Chinese Medical Device Regulations for Product Approval



 
Our Price: $395.00

Product Code: WB-7115
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About the Product
Includes 1 hour Windows Media Video File with 25 minute Q&A session and PowerPoint presentations for immediate download.

Medical device manufacturers seek to gain clearance and approval for products in a booming Chinese market that is expected to exceed $53 billion in revenue, by 2020. However, with the restructuring of the Chinese Food and Drug Administration and Revision of the Regulation on the Supervision and Administration of Medical Devices, regulatory affairs executives face stricter regulatory expectations than ever before. This presentation will highlight the challenges of navigating new Chinese clearance and approval processes including conducting local clinical trials, medical device labeling requirements and CFDA communication and processing timelines.

  • Addressing difficulties with conducting local clinical trials
  • Best practices for communication & transparency with CFDA
  • Recent experiences with device approval in China

Speaker:

Xiaoyun He
Regulatory Affairs Manager
Cook Incorporated


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

  • Regulatory Affairs
  • Compliance
  • Legal Counsel

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