China’s National Medical Products Administration granted Class III medical device approval to Berry Genomics’ Sequel II CNDx workflow built on PacBio HiFi sequencing, marking the first regulatory clearance for a clinical‑grade long‑read sequencer in China. The approval covers a thalassemia‑focused assay and accompanying software, enabling an end‑to‑end long‑read testing workflow for carrier and prenatal screening. PacBio and Berry highlighted HiFi sequencing’s capacity to detect SNVs, indels, CNVs, structural variants and repeat expansions in a single test, addressing variant classes that are challenging for short‑read approaches. Company executives framed the clearance as a move to improve clinical outcomes for high‑incidence genetic disorders in China and to accelerate adoption of long‑read testing in hospitals and diagnostic labs. Clinical labs and health systems will assess integration pathways and reimbursement for phasing in long‑read diagnostics; the clearance also signals regulatory openness to more complex genomic assays and could accelerate competitive dynamics in global clinical genomics.