NMPA Major Updates Concerning IVDs

On June 9, the CMDE (Center of Medical Device Evaluation) of NMPA (National Medical Products Administration) announced the initiative to draft the technical review guidelines for the registration of:

• Reagents for rotavirus antigen tests
• Real-time qPCR instruments
• Reagents for testing IgM and IgG antibodies against HPV B19
• Reagents for GBS nucleic acid tests

Manufacturers of the above products were invited to sign up and cooperate with the CMDE to provide any needed assistance.

On July 1, the CMDE released the technical review guidelines (2^nd draft) for the change of licensing items for IVD Reagents. The CMDE is currently soliciting public comments until July 25, 2020.

On July 3, the CMDE of NMPA announced the initiative to draft the technical review guidelines for the registration of IVD reagents utilizing overseas clinical data.

By Jacky Li. Contact Cisema if you would like to learn more about the above news.