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Classification
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About CMDRD
Issuance date
2016
2015
2014
2013
2012
2011
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2009
before2008
RegDoc.
Main Enabling Legislation
Registration
Classification
Manufacture
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Import/Export
QMS
Clinical Verification
Labeling/Packaging
Adverse Event Monitoring
Reevaluation/Recall
Administrative Supervision
Medical Device Inventory
Regulations
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)
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)
2014
Administrative-Supervision
Administrative Measures for Medical Device Supervision Inspector (Exposure Draft)(CFDA notice No. 129 2014)
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)
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