By Fineline Cube 
China’s National Medical Products Administration (NMPA) released the “Guidelines for Classification Definition of Next-Generation Sequencing (NGS)-Related In Vitro Diagnostic (IVD) Reagents,” effective immediately. The guidelines aim to standardize the classification and regulation of NGS-related IVD reagents.
Classification Details
NGS-related IVD reagents are categorized into functional units, including nucleic acid extraction/purification reagents, library construction reagents, and general sequencing reaction reagents. The guidelines specify that nucleic acid extraction/purification reagents and general sequencing reaction reagents are classified as Class I IVD reagents. Library construction reagents are managed as Class III IVD reagents and must not be split into multiple components for registration submissions. The guidelines encourage combining general sequencing reaction reagents with library construction reagents into a single registration unit for joint application as Class III IVD reagents.
Requirements for Previously Registered Products
For NGS-related IVD reagents previously registered as Class I before the guidelines were released, registrants must conduct self-assessments against the new requirements. Cases requiring filing modifications or cancellations shall be processed in accordance with regulations. Products no longer qualifying as Class I IVDs must be re-registered with relevant medical product authorities. Starting January 1, 2027, non-compliant reagents without proper registration certification shall be prohibited from production, importation, and sale.-Fineline Info & Tech