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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
2009
Registration
Technical Review Guiding Principles of Registration for Tracheal Intubation
2009
Registration
Technical Review Guiding Principles of Registration for Orthopedic External Fixation Support
2009
Registration
Technical Review Guiding Principles of Registration for X-Ray Diagnostic Equipment of Class II
2009
Registration
Application Materials Guiding Principles of Registration for Medical Devices with Drug
2009
Registration
Application Materials Guiding Principles of Registration for Passive Implantable Medical Devices
2009
Registration
Application Materials Guiding Principles of Registration for Medical Devices of Animal Origin
Before 2008
Registration
Technical Review Guiding Principles of Registration for Hard-pipe Endoscope of Class II
Before 2008
Registration
Technical Review Guiding Principles of Registration for Fiber Endoscope of Class II
2012
Use
Centralized procurement specification for A class large medical equipment(MOH notice No. 96 2012)
2012
Use
Centralized procurement specification for high-value medical consumables(MOH notice No. 86 2012)
2010
Use
The Safety Management Practices for Medical Device Clinical Use(MOH notice No. 4 2010)
2011
Use
Administrative Measures for Medical Equipment of Medical Organisation(MOH)
2014
QMS
The Quality Management Practices for Medical Device Use (Exposure Draft)(CFDA notice No. 51 2014)
2010
Registration
Review procedure for medical device registration (SFDA notice No.92 2010)
2009
Registration
Emergency Review and Approval Procedure for Medical Devices (SFDA notice No.565 2009)
Before 2008
Registration
The guide for medical device biological assessment and review(SFDA notice No.345 2007)
2011
Reevaluation-Recall
The Provisions for Medical Device Recall (interim)(MOH order No. 82 2011)
2014
Manufacture
The Management Provisions for Medical Device Manufacturing Enterprise Classification(CFDA notice No. 234 2014)
2014
QMS
The Quality Management Practices for Medical Device Manufacturing(CFDA Announcement No.64 2014)
2015
Manufacture
The guide on supplier audit for Medical Device Manufacturing Enterprise(CFDA Announcement No.1 2015)
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