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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
  • 2015 Administrative-Supervision
  • Measures for Unannounced Inspection of Drugs and Medical Devices (CFDA Order No.14 2015)
  • 2015 Classification
  • Rules for Classification of Medical Devices (CFDA Order No.15 2015)
  • 2015 Use
  • Administrative Measures for Quality Supervision on the Use of Medical Devices (CFDA Order No.18 2015)
  • 2015 Registration
  • Naming Rules for Medical Device Generic Name (CFDA Order No.19 2015)
  • 2015 Clinical-Verification
  • Technical Guideline for Clinical Evaluation of Medical Devices (CFDA notice No. 14, 2015)
  • 2015 Registration
  • Technical Review Guiding Principles of Registration for Antibody Reagent and Detection Kit of Estrogen Receptor and Progestrone Receptor
  • 2015 Manufacture
  • The guide on supplier audit for Medical Device Manufacturing Enterprise(CFDA Announcement No.1 2015)
  • 2015 Registration
  • Principle for Dividing for the Registered Units of In Vitro Diagnostic Product (Exposure Draft) (Seek for opinions)
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  • 1 Page(s)
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