Regulations - China Medical Device Regulatory Database

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2016
2015
2014
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2011
2010
2009
before2008

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Main Enabling Legislation
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Administrative Supervision
Medical Device Inventory

Regulations

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
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
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)
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 Registration
Announcement of the Format of Evidentiary Documents of the Requirements and Approval for the Registration and Application (CFDA Announcement No.43 2014)

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