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NMPA Issued 7 Guidelines for Technical Review of the Registration of Colloidal Gold Immunochromatographic Analyzer

CCFDIE| Updated: 2020-03-05

To strengthen the supervision and guidance over the registration of medical device products and further improve the quality of registration review, NMPA has organized the formulation of and released on March 5, 2020 the Guidelines for Technical Review of the Registration of Colloidal Gold Immunochromatographic Analyzers, Guidelines for Technical Review of the Registration of Folliclestimulating Hormone Detection Reagents, Guidelines for Technical Review of the Registration of Creatinine Detection Reagents, Guidelines for Technical Review of the Registration of Antinuclear Antibody Detection Reagents, Guidelines for Technical Review of the Registration of Antithyroid Peroxidase Antibody Assay Reagents, Guidelines for Technical Review of the Registration of Glycated Albumin Assay Reagents, and the Guidelines for Technical Review of the Registration of Total Bile Acid Assay Reagents.