Toggle navigation
Classification
Regulations
Standards
Support
About CMDRD
Issuance date
2016
2015
2014
2013
2012
2011
2010
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
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)
2015
Registration
Naming Rules for Medical Device Generic Name (CFDA Order No.19 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)
2015
Registration
Technical Review Guiding Principles of Registration for Antibody Reagent and Detection Kit of Estrogen Receptor and Progestrone Receptor
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
2014
Registration
Technical Review Guiding Principles of Registration for Medical Msak
2014
Registration
Technical Review Guiding Principles of Registration for Medical Temperature Blankets
2014
Registration
Technical Review Guiding Principles of Registration for Clinical Electronic Thermometer
2014
Registration
Technical Review Guiding Principles of Registration for Disposable Medical Laryngeal Mask
2014
Registration
Technical Review Guiding Principles of Registration for Disposable Drain Tube
2014
Registration
Technical Review Guiding Principles of Registration for Disposable Skin Suturing Set
2014
Registration
Technical Review Guiding Principles of Registration for Dental Handpiece
2014
Registration
Technical Review Guiding Principles of Registration for Detection Reagent Ischemia Modified Albumin (IMA)
2014
Registration
Technical Review Guiding Principles of Registration for Pulse Oximeter
2014
Registration
Technical Review Guiding Principles of Registration for Alkaline Phosphatase Detection Kit
2014
Registration
Technical Review Guiding Principles of Registration for Creatine Kinase Detection Kit
1
2
3
4
5
6
6 Page(s)
