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Latest Regulations

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Notice of the State Food and Drug Administration on Issuing Technical Guidelines for Clinical Trials of In Vitro Diagnostic Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2014年第16号 Registration & Filing 2014-09-11 2014-10-01
Status Issued By Level of Legal Effect Product Category Obsolete NMPA/National Medical … Guidelines IVD
Key points for the evaluation of detection reagents for human infection with H7N9 avian influenza virus
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20140709 Registration & Filing 2014-07-09 2014-07-09
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Review Key Points IVD
Notice of the State Food and Drug Administration on Issuing the Guiding Principles for Technical Review of Registration of Implantable Heart Electrode Wire Products
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2014年第10号 Registration & Filing 2014-06-04 2014-06-04
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the State Food and Drug Administration on Issuing the Guiding Principles for Technical Review of 14 Medical Device Products Registration, including Medical Masks
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2014年第7号-f10 Registration & Filing 2014-05-20 2014-05-20
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the State Food and Drug Administration on Issuing the Guiding Principles for Technical Review of Registration of 14 Medical Device Products, including Disposable Drainage Tubes
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2014年第7号-f11 Registration & Filing 2014-05-20 2014-05-20
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the State Food and Drug Administration on Issuing the Guiding Principles for Technical Review of Registration of Cardiac Radiofrequency Ablation Catheters
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2014年第5号 Registration & Filing 2014-05-14 2014-05-14
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the State Food and Drug Administration on Issuing the Guiding Principles for Technical Review of Registration of Five Medical Device Products, including Metal Plate Internal Fixation Systems
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2014年第6号-f5 Registration & Filing 2014-05-14 2014-05-14
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the State Food and Drug Administration on Issuing the Guiding Principles for Technical Review of Registration of Five Medical Device Products, including Dental Resin Filling Materials
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2014年第6号-f1 Registration & Filing 2014-05-14 2014-05-14
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the State Food and Drug Administration on Issuing the Technical Review Guidelines for the Registration of Four Medical Device Products, including Toxoplasma gondii, Rubella virus, Cytomegalovirus, Herpes simplex virus antibodies, and G-type immunoglobulin antibody affinity testing reagents
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2014年第2号-f2 Registration & Filing 2014-03-13 2014-03-13
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Notice of the State Food and Drug Administration on Issuing the Guiding Principles for Technical Review of Registration of Four Medical Device Products, including Medical Magnetic Resonance Imaging Systems
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2014年第2号-f1 Registration & Filing 2014-03-13 2014-03-13
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
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