PacBio and partner Berry Genomics announced that the Sequel II CNDx system received Class III medical device registration from China’s NMPA—the first regulatory clearance for a clinical‑grade long‑read sequencer. Berry’s thalassemia assay and software were cleared alongside the platform, creating an end‑to‑end HiFi sequencing workflow for prenatal, newborn, carrier and rare‑disease testing in China. PacBio framed the approval as validation of HiFi long‑read accuracy for complex variant detection (SNVs, indels, SVs, repeat expansions) and highlighted implications for high‑incidence genetic disorders that are difficult to resolve with short‑read approaches. The move may accelerate clinical adoption of long‑read sequencing in large healthcare markets.