Regulations - China Medical Device Regulatory Database

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2016
2015
2014
2013
2012
2011
2010
2009
before2008

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Main Enabling Legislation
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Adverse Event Monitoring
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Administrative Supervision
Medical Device Inventory

Regulations

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
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
2009 Registration
Emergency Review and Approval Procedure for Medical Devices (SFDA notice No.565 2009)
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)

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