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2014 Revision of Chinese Medical Device Regulations for Product Approval
Our Price:
$
395.00
Product Code:
WB-7115
Qty:
Product Info
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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Our Price:
$395.00
Our Price:
$395.00
Our Price:
$395.00
Our Price:
$395.00
Analyzing FDA Guidance to Develop Adequate Reprocessing Instructions for Devices
Harmonizing Supplier Quality Practices Across Divisions within a Medical Device Company
FDA Reports of Corrections and Removals for Medical Devices
Utilizing GS1 Standards to Comply with FDA UDI Requirements
Our Price:
$395.00
Our Price:
$395.00
Our Price:
$395.00
Our Price:
$395.00
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