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Latest Chinese Guidebook for Application and Approval of Imported Medical Device Registration: From Regulations to Practices
Date:9/3/2014

l trials for imported overseas medical devices to the application for approval of imported overseas medical device registration to smoothly navigate complex regulatory requirements step by step.
  • Chapter 15 provides the practical guidance for alteration registration and renewal registration of imported overseas medical devices, also from

  • Report Highlights 

    • An overview of the latest Chinese applicable regulations for imported overseas medical device registration and recordation.
    • What Chinese regulations on medical devices are undergoing earthshaking changes? An overview of organizational structure of Chinese regulatory authorities for imported medical device registration and recordation to give the direction of gateway for imported medical device registration and recordation.
    • The knowledge preparation before application of imported overseas medical device registration and recordation to let overseas medical device manufacturer understand the unique Chinese approach for medical device registration and lay the knowledge foundation for the practical operation.
    • The latest Chinese regulations for application for imported medical device recordation, which is applicable to Class I imported overseas medical devices.
    • The latest Chinese regulations for application and approval for imported medical device registration, which is applicable to Class II and II imported overseas medical devices.
    • The detailed Chinese medical device classification.
    • The rights of human subjects and every party's responsibilities in clinical trials for imported overseas medical devices in China.
    • The practical guidance for application of imported overseas medical device recordation, from how to compile recordation documents, how to apply for recordation to how to handle alteration recordation to smoothly navigate complex regulator
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    SOURCE Bharat Book Bureau
    Copyright©2014 PR Newswire.
    All rights reserved

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