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NMPA Issued 4 Guidelines for Technical Review of the Registration of EB Virus Nucleic Acid Detection Reagents

CCFDIE| Updated: 2020-03-10

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 10, 2020 the Guidelines for Technical Review of the Registration of EB Virus Nucleic Acid Detection Reagents, Guidelines for Technical Review of the Registration of HBV e Antigen, e Antibody Detection Reagents, Guidelines for Technical Review of the Registration of Thalassemia-Related Gene Detection Reagents, and Guidelines for Technical Review of the Registration of HBV-Resistant Gene Mutation Detection Reagents.