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Issuance date

  • 2016
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  • 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
  • 2013 Registration
  • Technical Review Guiding Principles of Registration for Qualitative Detection Reagent of Specific M Immune Globulin of Pathogene
  • 2013 Registration
  • Technical Review Guiding Principles of Registration for Disposable Dialyzer
  • 2013 Registration
  • Technical Review Guiding Principles of Registration for Biochip Detection Reagent
  • 2013 Registration
  • Technical Review Guiding Principles of Registration for ELISA Detection Reagent
  • 2013 Registration
  • Technical Review Guiding Principles of Registration for Detection Reagent of Golden Standard
  • 2013 Registration
  • Technical Review Guiding Principles of Registration for Nucleic Acid Amplification Testing Reagent
  • 2013 Registration
  • Technical Review Guiding Principles of Registration for Luminescence Immunity Detection Reagent
  • 2013 Administrative-Supervision
  • Administrative provisions for medical device quality supervision and spot check(Exposure Draft)(CFDA notice No. 46 2013)
  • 2013 Clinical-Verification
  • Temporary provisions for medical device clinical trials approval(Exposure Draft)(CFDA notice No. 65 2013)
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