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Latest Regulations

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Notice of the State Administration on Issuing the Guiding Principles for the Review of Three Registration Technologies, including D-dimer Assay Reagents (Immunoturbidimetry)
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2018年第9号-f3 Registration & Filing 2018-01-16 2018-01-08
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Notice of the State Administration on Issuing the Guiding Principles for the Review of Five Registration Technologies, including Homocysteine Testing Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2018年第8号-f3 Registration & Filing 2018-01-16 2018-01-08
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Notice of the State Administration on Issuing the Guiding Principles for the Review of Five Registration Technologies, including Urine Analysis Test Strips
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2018年第8号-f2 Registration & Filing 2018-01-16 2018-01-08
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Notice of the State Administration on Issuing the Guiding Principles for the Review of Three Registration Technologies, including Apolipoprotein A1 Assay Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2018年第9号-f1 Registration & Filing 2018-01-16 2018-01-08
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Notice of the State Administration on Issuing the Guiding Principles for the Review of Three Registration Technologies, including Apolipoprotein B Assay Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2018年第9号-f2 Registration & Filing 2018-01-16 2018-01-08
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Notice of the State Administration on Issuing Technical Guidelines for Accepting Overseas Clinical Trial Data of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2018年第13号 Clinical Evaluation 2018-01-11 2018-01-11
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Notice of the State Administration on Issuing Three Technical Review Guiding Principles for Disposable Infusion Pumps (Non Electric Drive) and Other Technologies
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2018年第3号-f2 Registration & Filing 2018-01-10 2018-01-03
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the State Administration on Issuing Three Technical Review Guidelines for Blood Concentrators and Other Technologies
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2018年第3号-f3 Registration & Filing 2018-01-10 2018-01-03
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the State Administration on Issuing Three Technical Review Guiding Principles for Whole Blood and Blood Component Storage Bags
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2018年第3号-f1 Registration & Filing 2018-01-10 2018-01-03
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Announcement of the State Administration on the Pilot Work of the Medical Device Registration System by the Shanghai Food and Drug Administration
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2018年第1号 Registration & Filing 2018-01-09 2018-01-05
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
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