Medical Device Priority Approval (No.10 of 2020)

On November 26, 2020, CMDE issued a notification that the “Hepatitis B Virus (HBV) Nucleic acid Quantitative Detection Kit (PCR-Fluorescence method)” of Suzhou Tianlong Bio-technology Co.,Ltd. is proposed to obtain the priority pathway approval because it is listed in the national science and technology major special medical devices. 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/CL0004/22040.html