PacBio and Berry Genomics secured Class III medical device registration from China’s NMPA for the Sequel II CNDx system—the first regulatory clearance for a clinical-grade long‑read sequencer. The approval, paired with Berry’s thalassemia assay and software, creates an end-to-end long‑read workflow for carrier, prenatal, newborn and rare-disease testing in Chinese hospitals and diagnostic labs. PacBio executives framed the clearance as enabling complete genomic views—SNVs, indels, CNVs, structural variants and repeat expansions—in a single test, improving detection of complex variants such as those in thalassemia. The system leverages HiFi sequencing to combine long reads with high accuracy. Regulatory clearance in China accelerates deployment in the country’s high-incidence genetic disorder markets and could pressure other regions to evaluate clinical long‑read workflows for diagnostic use.