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NMPA Announcement on the Issuance of Five Guidelines for Technical Review of the Registration of Human Chromosomal Abnormality Detection Reagents Based on Cytofluorometric In Situ Hybridization and Others

Updated: 2019-11-15

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 November 15, 2019 the Guidelines for Technical Review of the Registration of Human Chromosome Abnormality Detection Reagents Based on Cytofluorometric In Situ Hybridization, Guidelines for Technical Review of the Registration of Multiple Nucleic Acids Detection Reagents for Respiratory Virus, Guidelines for Technical Review of the Registration of Nucleic Acid-Based Detection Reagents for Staphylococcus Aureus and Methicillin-Resistant Staphylococcus Aureus, Guidelines for Technical Review of the Registration of Detection Reagents for Chlamydia Trachomatis and / or Neisseria Gonorrhoeae Nucleic Acids, and Guidelines for Technical Review of the Registration of Amino Acid, Carnitine, and Succinylacetone.