The National Medical Products Administration granted Class III medical device registration in China for Berry Genomics’ Sequel II CNDx system based on PacBio HiFi long‑read sequencing. PacBio said the approval is the world’s first regulatory clearance for a clinical‑grade long‑read sequencer and will enable comprehensive genomic assays for thalassemia, prenatal and rare‑disease testing in China. PacBio CEO Christian Henry and Berry Genomics R&D leaders noted that long‑read accuracy and structural‑variant detection can resolve complex variants that short reads miss, potentially improving diagnostic yield for high‑incidence genetic disorders. The approval also creates an end‑to‑end HiFi workflow for clinical labs in China.