Home> Medical Devices

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

CCFDIE|Updated: 2021-01-19

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.