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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
Notice of the State Food and Drug Administration on Issuing the Guiding Principles for Technical Review of Registration of Four Medical Device Products, including Drug Abuse Detection Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2014年第2号-f4 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 Gene Mutation Testing Reagents for Individualized Tumor Therapy
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2014年第2号-f3 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 General Office of the Food and Drug Administration and the General Office of the National Health and Family Planning Commission on Strengthening the Management of Clinical Use of Gene Sequencing Related Products and Technologies
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械管[2014]25号 Usage 2014-02-09 2014-02-09
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Notice of the General Office of the Food and Drug Administration on Issuing Guidelines for Daily Supervision and On site Inspection of Medical Device Production
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械监[2014]7号 Supervision & Inspection,Manufacturing 2014-01-13 2014-01-13
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Explanation on the Administrative Reconsideration Measures of the State Food and Drug Administration
Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20131206 Supervision & Inspection 2013-12-06 2013-12-06
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Work Documents IVD
Notice of the State Administration of Food and Drug Administration on Issuing the Sub Catalogue of in vitro Diagnostic Reagent Classification
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监械管[2013]242号 Pre-Market 2013-11-26 2013-11-26
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Administrative Reconsideration Measures of the State Food and Drug Administration
Regulation No. Product LifeCycle Issued Date Implemented Date 总局令2013年第2号 Supervision & Inspection 2013-11-06 2014-01-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … UNKNOWN UNKNOWN
Legislative Procedure Regulations of the State Food and Drug Administration
Regulation No. Product LifeCycle Issued Date Implemented Date 总局令2013年第1号 Supervision & Inspection 2013-10-24 2013-12-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … UNKNOWN UNKNOWN
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