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Latest Regulations

1882  Results

Interpretation of the Quality Management Standards for Clinical Trials of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20160323 Clinical Evaluation 2016-03-23 2016-03-23
Status Issued By Level of Legal Effect Product Category Obsolete NMPA/National Medical … Work Documents Medical Device
Quality Management Specification for Clinical Trials of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 总局&国家卫计委令2016年第25号 Clinical Evaluation 2016-03-23 2016-06-01
Status Issued By Level of Legal Effect Product Category Obsolete NMPA/National Medical … UNKNOWN UNKNOWN
Notice on Relevant Issues in the Evaluation of Contact Lens Products
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20160316 Product Type Testing 2016-03-16 2016-03-16
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Work Documents Medical Device
Notice of the State Administration on Issuing the Guiding Principles for Technical Review of Registration of Six Medical Devices, including Alkaline Phosphatase Assay Kits (Revised in 2016)
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2016年第28号-f1 Registration & Filing 2016-03-03 2016-03-03
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
State Administration of Industry and Commerce β Notice on the Guiding Principles for Technical Review of Registration of 7 Medical Devices, including 2-Microglobulin Detection Kit (Latex Enhanced Immunoturbidimetry)
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2016年第29号-f7 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 Fecal occult blood (FOB) Test Kits (Colloidal Gold Immunochromatography) (Revised in 2016)
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2016年第28号-f4 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 7 Medical Devices, including Glycosylated Hemoglobin Test Kits (Enzyme Method)
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2016年第29号-f2 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 Seven Medical Devices, including Salivary Acid Testing Kits (Enzyme Method)
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2016年第29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 Seven Medical Devices, including Thyroid Stimulating Hormone Testing Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2016年第29号-f4 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 Seven Medical Devices, including Albumin Determination Reagents (Kits)
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2016年第29号-f1 Registration & Filing 2016-03-03 2016-03-03
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
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