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About CMDRD
Issuance date
2016
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before2008
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Main Enabling Legislation
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Medical Device Inventory
Regulations
2014
Main-Enabling-Legislation
Regulations for the Supervision and Administration of Medical Devices (Decree No.650 2014)
2014
Registration
Administrative Measures for Medical Device Registration (CFDA Order No. 4 2014)
2014
Registration
Administrative Measures for the Registration of In Vitro Diagnostic Reagents (CFDA Order No. 5 2014)
2014
Labeling-Packaging
Administrative Rules for the Instructions and Labels of Medical Devices (CFDA Order No. 6 2014)
2014
Manufacture
Administrative Measures for the Supervision of Medical Device Manufacturing (CFDA Order No. 7 2014)
2014
Distribution
Administrative Measures for the Supervision of distribution of Medical Devices (CFDA Order No. 8 2014)
2014
Registration
The Guideline on Preparation of Medical Device Technical Requirements (CFDA Notice No.9 2014)
2014
Registration
Special Review and Approval Procedure for Innovative Medical Devices (interim) (CFDA notice No.13 2014)
2014
Clinical-Verification
The Technical Guidelines for In Vitro Diagnostic Reagents Clinical Trial (CFDA notice No. 16 2014)
2014
Labeling-Packaging
Writing Guiding Principles of Instruction for In Vitro Diagnostic Reagent
2014
Registration
Technical Guiding Principles of Clinical Trial for In Vitro Diagnostic Reagent
2014
Registration
Technical Review Guiding Principles of Registration for Implanted Cardiac Lead
2014
Registration
Writing Guiding Principles of Technical Requirements for Medical Device
2014
Registration
Technical Review Guiding Principles of Registration for Medical Msak
2014
Registration
Technical Review Guiding Principles of Registration for Medical Temperature Blankets
2014
Registration
Technical Review Guiding Principles of Registration for Clinical Electronic Thermometer
2014
Registration
Technical Review Guiding Principles of Registration for Disposable Medical Laryngeal Mask
2014
Registration
Technical Review Guiding Principles of Registration for Disposable Drain Tube
2014
Registration
Technical Review Guiding Principles of Registration for Disposable Skin Suturing Set
2014
Registration
Technical Review Guiding Principles of Registration for Dental Handpiece
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