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NMPA Issued Four Guidelines for Technical Review of the Registration of Assay Reagents for Aspartate Aminotransferase and Others

Updated: 2019-10-29

To strengthen the supervision and guidance over medical device product registration and further improve the quality of registration review, NMPA has organized the formulation of and released on October 29, 2019 the Guidelines for Technical Review of the Registration of Assay Reagents for Aspartate Aminotransferase, Guidelines for Technical Review of the Registration of Total Cholesterol Assay Reagents, Guidelines for the Technical Review of Registration of Uric Acid Determination Reagents, and Guidelines for Technical Review of the Registration of Urea Determination Reagents.