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Latest Regulations

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Management Measures for Registration of In Vitro Diagnostic Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date 总局令2014年第5号 Registration & Filing 2014-07-30 2014-10-01
Status Issued By Level of Legal Effect Product Category Obsolete NMPA/National Medical … UNKNOWN UNKNOWN
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
Announcement of the State Food and Drug Administration on Matters Related to the Filing of Class I Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2014年第26号 Registration & Filing 2014-05-30 2014-05-30
Status Issued By Level of Legal Effect Product Category Obsolete NMPA/National Medical … Announcements IVD
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 Guiding Principles for Writing Two Instructions for Hard Corneal Contact Lenses and Other Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2014年第3号-f2 Registration & Filing 2014-04-17 2014-04-17
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
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