China’s NMPA Issues New Guideline on NGS-Based IVD Reagent Classification
On June 16, 2025, China’s National Medical Products Administration (NMPA) released a new “Guidance for the Classification of In Vitro Diagnostic (IVD) Reagents Related to Next-Generation Sequencing (NGS),” effective immediately. The document explains classification and regulation rules for NGS-based IVDs and requests manufacturers... Read More