On June 16, 2025, China’s National Medical Products Administration (NMPA) released a new “Guidance for the Classification of In Vitro Diagnostic (IVD) Reagents Related to Next-Generation Sequencing (NGS),” effective immediately. The document explains classification and regulation rules for NGS-based IVDs and requests manufacturers to make sure their product applications are compliant.
According to the new rules, general sequencing reagents and library construction reagents can be jointly registered as Class III IVDs, unless there are clear distinctions between the two. Companies with existing active Class I filings will need to examine and, if necessary, reclassify their devices. NGS IVDs that are inappropriately registered may no longer be manufactured, imported, or distributed by January 1, 2027. The NMPA also added that this guideline is part of a comprehensive action to improve regulation and encourage high-quality development of the fast-growing NGS diagnostic market.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.