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
2011
Registration
Application Materials Guiding Principles of Registration for Quantitative Detection of Tumor Markers
2011
Registration
Technical Review Guiding Principles of Registration for Disposable Infusion and Injection
2011
Registration
Technical Review Guiding Principles of Registration for Dental Implant (System)
2011
Registration
Application Materials Guiding Principles of Shelf-Life for Passive Implantable Medical Devices
2011
Registration
Technical Review Guiding Principles of Virus Inactivating Technology for Allogenic Implantable Medical Device
2011
Registration
Technical Review Guiding Principles of Analysis Performance Evaluation (Accuracy- Recovery Rate Test) for IVD
2011
Registration
Technical Review Guiding Principles of Analysis Performance Evaluation (Accuracy-Methodology Comparison Test) for IVD
2011
Registration
Technical Review Guiding Principles of Registration for Breast Implants
2011
Registration
Technical Review Guiding Principles of Registration for Care Product of Contact Lens
2010
Registration
Technical Review Guiding Principles of Registration for Implantable Pacemaker
2010
Registration
Technical Review Guiding Principles of Registration for Image Diagnostic Ultrasonic Equipment Class III
2010
Registration
Technical Review Guiding Principles of Registration for Medical X-Ray Diagnostic Equipment of Class III
2009
Registration
Technical Review Guiding Principles of Registration for Surgical Gauze Dressing of Class II
2009
Registration
Technical Review Guiding Principles of Registration for Biochemical Analyzer
2009
Registration
Technical Review Guiding Principles of Registration for Motor-Driven Operating Table
2009
Registration
Technical Review Guiding Principles of Registration for Multi-Parameter Patient Monitoring Devices
2009
Registration
Technical Review Guiding Principles of Registration for B Mode Ultrasonic Diagnostic Equipment of Class II
2009
Registration
Technical Review Guiding Principles of Registration for Disposable Asepsis Catheter
2009
Registration
Technical Review Guiding Principles of Registration for Electrocardiograph
2009
Registration
Technical Review Guiding Principles of Registration for Stomach Tube
1
2
3
4
5
6
7
8
8 Page(s)
