Regulatory

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1061 Results

Notice of the State Administration on Issuing the Guiding Principles for Technical Review of Registration of Six Medical Devices, including Ischemic Modified Albumin Assay Kits (Revised in 2016)

Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2016年第28号-f5 Registration & Filing 2016-03-03 2016-03-03

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 Technical Review of Registration of Six Medical Devices, including Creatine Kinase Assay Reagents (Kits) (Revised in 2016)

Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2016年第28号-f6 Registration & Filing 2016-03-03 2016-03-03

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 Technical Review of Registration of 13 Medical Devices, including X-ray Diagnostic Equipment (Class II) (Revised in 2016)

Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2016年第22号-f3 Registration & Filing 2016-02-19 2016-02-19

Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device

Notice of the State Administration on Issuing the Guiding Principles for Technical Review of Registration of 13 Medical Devices, including Semiautomatic Chemiluminescence Immunoassay Analyzers (Revised in 2016)

Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2016年第22号-f5 Registration & Filing 2016-02-19 2016-02-19

Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device

Notice of the State Administration on Issuing the Guiding Principles for Technical Review of 13 Medical Devices Registration, including Water Preparation Equipment for Hemodialysis (Revised in 2016)

Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2016年第22号-f9 Registration & Filing 2016-02-19 2016-02-19

Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device

Notice of the State Administration on Issuing the Guiding Principles for Technical Review of Registration of 13 Medical Devices, including Electronic Blood Pressure Gauges (Oscillographic Method) (Revised in 2016)

Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2016年第22号-f2 Registration & Filing 2016-02-19 2016-02-19

Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device

Notice of the State Administration on Issuing the Guiding Principles for Technical Review of Registration of 13 Medical Devices, including Dental Comprehensive Treatment Machines (Revised in 2016)

Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2016年第22号-f10 Registration & Filing 2016-02-19 2016-02-19

Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device

Notice of the State Administration on Issuing the Guiding Principles for Technical Review of 13 Medical Device Registration Technologies, including Biochemical Analyzers (Revised in 2016)

Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2016年第22号-f7 Registration & Filing 2016-02-19 2016-02-19

Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device

Notice of the State Administration on Issuing the Guiding Principles for Technical Review of Registration of 13 Medical Devices, including Automatic Urine Sediment Analyzer (Revised in 2016)

Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2016年第22号-f13 Registration & Filing 2016-02-19 2016-02-19

Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device

Notice of the State Administration on Issuing Six Guiding Principles for Technical Review of Medical Device Registration, including the Guiding Principles for Technical Review of Positive Pressure Ventilation Therapy Machines

Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2016年第27号-f2 Registration & Filing 2016-02-19 2016-02-19

Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device

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