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  • About CMDRD

Issuance date

  • 2016
  • 2015
  • 2014
  • 2013
  • 2012
  • 2011
  • 2010
  • 2009
  • before2008

RegDoc.

  • Main Enabling Legislation
  • Registration
  • Classification
  • Manufacture
  • Distribution
  • Use
  • Import/Export
  • QMS
  • Clinical Verification
  • Labeling/Packaging
  • Adverse Event Monitoring
  • Reevaluation/Recall
  • Administrative Supervision
  • Medical Device Inventory
  • Regulations
  • 2009 Registration
  • Technical Review Guiding Principles of Registration for Motor-Driven Operating Table
  • 2009 Registration
  • Technical Review Guiding Principles of Registration for Multi-Parameter Patient Monitoring Devices
  • 2009 Registration
  • Technical Review Guiding Principles of Registration for B Mode Ultrasonic Diagnostic Equipment of Class II
  • 2009 Registration
  • Technical Review Guiding Principles of Registration for Disposable Asepsis Catheter
  • 2009 Registration
  • Technical Review Guiding Principles of Registration for Electrocardiograph
  • 2009 Registration
  • Technical Review Guiding Principles of Registration for Stomach Tube
  • 2009 Registration
  • Technical Review Guiding Principles of Registration for Tracheal Intubation
  • 2009 Registration
  • Technical Review Guiding Principles of Registration for Orthopedic External Fixation Support
  • 2009 Registration
  • Technical Review Guiding Principles of Registration for X-Ray Diagnostic Equipment of Class II
  • 2009 Registration
  • Application Materials Guiding Principles of Registration for Medical Devices with Drug
  • 2009 Registration
  • Application Materials Guiding Principles of Registration for Passive Implantable Medical Devices
  • 2009 Registration
  • Application Materials Guiding Principles of Registration for Medical Devices of Animal Origin
  • Before 2008 Registration
  • Technical Review Guiding Principles of Registration for Hard-pipe Endoscope of Class II
  • Before 2008 Registration
  • Technical Review Guiding Principles of Registration for Fiber Endoscope of Class II
  • 2010 Registration
  • Review procedure for medical device registration (SFDA notice No.92 2010)
  • 2009 Registration
  • Emergency Review and Approval Procedure for Medical Devices (SFDA notice No.565 2009)
  • Before 2008 Registration
  • The guide for medical device biological assessment and review(SFDA notice No.345 2007)
  • 2015 Registration
  • Principle for Dividing for the Registered Units of In Vitro Diagnostic Product (Exposure Draft) (Seek for opinions)
  • 2014 Registration
  • Announcement of Relevant Issues on Implementing Provisions for Medical Device Registration and Provisions for IVD (CFDA Announcement No.144 2014)
  • 2014 Registration
  • Announcement of the Format of Evidentiary Documents of the Requirements and Approval for the Registration and Application (CFDA Announcement No.43 2014)
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