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Classification
Regulations
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About CMDRD
Issuance date
2016
2015
2014
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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
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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