Seven New Guidelines for IVD Registration

On March 5, 2020, NMPA released seven guidelines of technical review for registration on IVD instrument and assays:

• Guidelines for the Technical Review of Colloidal Gold ICA analyzer Registration
• Guidelines for the Technical Review of hFSH Assay Reagent Registration
• Guidelines for the Technical Review of Creatinine PAP Registration
• Guidelines for the Technical Review of ANA Assay Reagent Registration
• Guidelines for the Technical Review of Anti-TPO Antibody Assay Reagent Registration
• Guidelines for the Technical Review of GA Assay Reagent Registration
• Guidelines for the Technical Review of Total Bile Acid Assay Reagent Registration.

Link: http://www.nmpa.gov.cn/WS04/CL2138/375280.html

Bradynuoen suggest manufactures to follow the new requirements to do relevant registration.