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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
2012
Manufacture
Working procedure on unannounced inspection for medical Device Manufacturing Enterprise( SFDA notice No.153 2012)
Before 2008
Import-Export
The Management Measures for Imported Medical Device Inspection and Supervision(AQSIQ Order No.95 2007)
2009
Distribution
The Examination Measures for Medical Device Advertisement(SFDA Order No. 65 2009)
2009
Distribution
The Evaluation and Publication Standard for Medical Device Advertisement(SFDA Order No. 40 2009)
2014
Distribution
Administrative Measures for the Supervision of distribution of food and drug on internet(Exposure Draft) (Seek for opinions)
2014
QMS
The Quality Management Practices for Medical Device Distributing (CFDA Announcement No.58 2014)
2013
Administrative-Supervision
Administrative provisions for medical device quality supervision and spot check(Exposure Draft)(CFDA notice No. 46 2013)
2014
Administrative-Supervision
Administrative Measures for Medical Device Supervision Inspector (Exposure Draft)(CFDA notice No. 129 2014)
2012
Administrative-Supervision
The Applicable Rules on Administrative Punishment Discretion for Drug and Medical Device(SFDA notice No.306 2012)
2013
Clinical-Verification
Temporary provisions for medical device clinical trials approval(Exposure Draft)(CFDA notice No. 65 2013)
2015
Registration
Principle for Dividing for the Registered Units of In Vitro Diagnostic Product (Exposure Draft) (Seek for opinions)
2014
Registration
Announcement of Relevant Issues on Implementing Provisions for Medical Device Registration and Provisions for IVD (CFDA Announcement No.144 2014)
2014
Manufacture
Announcement of Relevant Issues on Implementing Provisions for Medical Device Manufacture and Provisions for Medical Device (CFDA Announcement No.143 2014)
2014
Registration
Announcement of the Format of Evidentiary Documents of the Requirements and Approval for the Registration and Application (CFDA Announcement No.43 2014)
2014
Classification
The Provisions of Medical Device Nomenclature (Exposure Draft)(Seek for opinions)
Before 2008
Adverse-Event-Monitoring
The Requirements for Medical Device Adverse Event Monitoring and Re-evaluation (SFDA notice No.766 2008)
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