PacBio and clinical partner Berry Genomics received Class III medical device registration from China’s National Medical Products Administration (NMPA) for the Sequel II CNDx system, marking the first regulatory clearance for a clinical‑grade long‑read sequencer in China. The approval enables Berry’s clinical thalassemia assay and software to operate as an end‑to‑end long‑read workflow in Chinese hospitals and diagnostic labs. PacBio executives framed the clearance as a milestone for precision medicine in China, noting the technology’s ability to resolve structural variants and complex loci that short‑read sequencing misses—critical for high‑incidence genetic disorders such as thalassemia. Berry said the approval will support carrier, prenatal, newborn and rare disease testing. The regulatory green light could accelerate clinical adoption of HiFi sequencing in a major market and intensify competition with short‑read incumbents, while prompting global labs to reassess the role of long‑read platforms in diagnostic workflows.