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NMPA Announcement on Issuing Three Guidelines for Technical Review of the Registration Including that of Mycoplasma Pneumoniae IgM/IgG Antibody Detection Reagents

2021-02-25 16:05:31 127

  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 January 18, 2021 the Guidelines for Technical Review of the Registration of Mycoplasma Pneumoniae IgM/IgG Antibody Detection Reagents, Guidelines for Technical Review of the Registration of Cryptococcus Capsular Polysaccharide Antigen Detection Reagents, and Guidelines for Technical Review of the Registration of Hereditary Hearing Loss Gene Mutation Detection Reagents.

 

国家药品监督管理局2021年第4号通告附件1.doc ( Mycoplasma Pneumoniae IgM/IgG Antibody Detection Reagents)

国家药品监督管理局2021年第4号通告附件2.doc (Cryptococcus capsular polysaccharide antigen detection reagent)

国家药品监督管理局2021年第4号通告附件3.doc (Genetic Deafness Related Gene Mutation Detection Reagent)