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Latest Regulations

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Notice of the Office of the State Food and Drug Administration on Issuing Six Guiding Principles, including Technical Review for Registration of Disposable Dialyzers
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械函[2013]3号-f6 Registration & Filing 2013-01-04 2013-01-04
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Basic requirements for registration and application materials of immunohistochemical antibody reagents and detection kits
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20130104 Registration & Filing 2013-01-04 2013-01-04
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Work Documents IVD
Notes on registration and application materials for dental mobile phones and related accessories
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20121116 Registration & Filing 2012-11-06 2012-11-06
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Work Documents Medical Device
Notice on Issuing the Guiding Principles for Technical Review of Registration of 12 Medical Device Products, including Medical Molecular Sieve Oxygen Production Equipment
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械函[2012]210号-f9 Registration & Filing 2012-05-10 2012-05-10
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice on Issuing the Guiding Principles for Technical Review of Registration of 12 Medical Device Products, including Surgical Power Equipment
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械函[2012]210号-f8 Registration & Filing 2012-05-10 2012-05-10
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice on Issuing Technical Review Guidelines for the Registration of 12 Medical Device Products, including Respiratory Pipelines for Anesthesia and Respiratory Machines
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械函[2012]210号-f11 Registration & Filing 2012-05-10 2012-05-10
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice on Soliciting Opinions on Three Guiding Principles, including the Technical Guidelines for Registration and Application of Virus-specific IgM Antibody Qualitative Detection Reagents (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20120428-2-f1 Registration & Filing 2012-04-28 2012-04-28
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD
Explanation on Basic Requirements for Medical Device Software Registration and Application
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20120428-1 Registration & Filing 2012-04-28 2012-04-28
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Work Documents Medical Device
Notes on registration and application of respiratory intubation products
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20120316 Registration & Filing 2012-03-16 2012-03-16
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Work Documents Medical Device
Notice on Issuing the Guiding Principles for the Registration and Application Materials of Two Medical Devices, including influenza Virus Nucleic Acid Testing Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械函[2011]540号-f1 Registration & Filing 2011-12-23 2011-12-23
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
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