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Classification
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About CMDRD
Issuance date
2016
2015
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2013
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2009
before2008
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Main Enabling Legislation
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Medical Device Inventory
Regulations
2013
Registration
Technical Review Guiding Principles of Registration for Qualitative Detection Reagent of Specific M Immune Globulin of Pathogene
2013
Registration
Technical Review Guiding Principles of Registration for Disposable Dialyzer
2013
Registration
Technical Review Guiding Principles of Registration for Biochip Detection Reagent
2013
Registration
Technical Review Guiding Principles of Registration for ELISA Detection Reagent
2013
Registration
Technical Review Guiding Principles of Registration for Detection Reagent of Golden Standard
2013
Registration
Technical Review Guiding Principles of Registration for Nucleic Acid Amplification Testing Reagent
2013
Registration
Technical Review Guiding Principles of Registration for Luminescence Immunity Detection Reagent
2013
Administrative-Supervision
Administrative provisions for medical device quality supervision and spot check(Exposure Draft)(CFDA notice No. 46 2013)
2013
Clinical-Verification
Temporary provisions for medical device clinical trials approval(Exposure Draft)(CFDA notice No. 65 2013)
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