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

y requirements step by step. z The practical guidance for application and approval of imported overseas medical device registration, also from how to compile application documents, how to conduct clinical 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.
  • The practical guidance for alteration registration and renewal registration of imported overseas medical devices, also from how to compile application documents to how to submit application documents step by step.
  • A complete set of full text in English of latest Chinese involving with the imported overseas medical device registration and recordation, which cover "Regulations for the Supervision and Administration of Medical Devices (2014 Edition)", "Measures for the Administration of Medical Device Registration(2014 Edition)", "Regulations on the Administration of the Instructions and Labels of Medical Devices (2014 Edition)", "Provisions for Clinical Trials of Medical Devices", and "Rules for Medical Device Classification".

  • Related Categories: 

    - Healthcare

    - Medical Device

    - Chinese Guidebook

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