Medical Device Priority Approval

On May 9, 2020, CMDE issued a notification that the “Fetal Chromosome Non-integral (T21, T18, T13) Detection Kit (semiconductor sequencing)” of CapitalBio Genomics is proposed to obtain the priority pathway approval, because this product is listed in the national key research and development plan. Priority pathway could accelerate the technical review from CMDE and shorten the registration timeline. Bradynuoen could help evaluate and offer support on priority registration.

Link:https://www.cmde.org.cn/CL0004/20875.html