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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
  • 2014 Main-Enabling-Legislation
  • Regulations for the Supervision and Administration of Medical Devices (Decree No.650 2014)
  • 2014 Registration
  • Administrative Measures for Medical Device Registration (CFDA Order No. 4 2014)
  • 2014 Registration
  • Administrative Measures for the Registration of In Vitro Diagnostic Reagents (CFDA Order No. 5 2014)
  • 2014 Labeling-Packaging
  • Administrative Rules for the Instructions and Labels of Medical Devices (CFDA Order No. 6 2014)
  • 2014 Manufacture
  • Administrative Measures for the Supervision of Medical Device Manufacturing (CFDA Order No. 7 2014)
  • 2014 Distribution
  • Administrative Measures for the Supervision of distribution of Medical Devices (CFDA Order No. 8 2014)
  • 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)
  • 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 Registration
  • The Guideline on Preparation of Medical Device Technical Requirements (CFDA Notice No.9 2014)
  • 2014 Registration
  • Special Review and Approval Procedure for Innovative Medical Devices (interim) (CFDA notice No.13 2014)
  • 2014 Clinical-Verification
  • The Technical Guidelines for In Vitro Diagnostic Reagents Clinical Trial (CFDA notice No. 16 2014)
  • 2015 Registration
  • Technical Review Guiding Principles of Registration for Antibody Reagent and Detection Kit of Estrogen Receptor and Progestrone Receptor
  • 2014 Labeling-Packaging
  • Writing Guiding Principles of Instruction for In Vitro Diagnostic Reagent
  • 2014 Registration
  • Technical Guiding Principles of Clinical Trial for In Vitro Diagnostic Reagent
  • 2014 Registration
  • Technical Review Guiding Principles of Registration for Implanted Cardiac Lead
  • 2014 Registration
  • Writing Guiding Principles of Technical Requirements for Medical Device
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