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Issuance date

  • 2016
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  • 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
  • 2016 Clinical-Verification
  • Good Clinical Practice for Medical Device (GCP) (CFDA Order No.25 2016)
  • 2015 Clinical-Verification
  • Technical Guideline for Clinical Evaluation of Medical Devices (CFDA notice No. 14, 2015)
  • 2014 Clinical-Verification
  • The Technical Guidelines for In Vitro Diagnostic Reagents Clinical Trial (CFDA notice No. 16 2014)
  • 2013 Clinical-Verification
  • Temporary provisions for medical device clinical trials approval(Exposure Draft)(CFDA notice No. 65 2013)
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