中国食品药品监管Issue(8)：4-11,8.DOI:10.3969/j.issn.1673-5390.2025.08.001
《二代基因测序相关体外诊断试剂分类界定指导原则》探讨
Interpretation of the Guiding Principles for the Classification Criteria of NGS-Related In Vitro Diagnostic Reagents
摘要
Abstract
To further strengthen the supervision and management of next-generation sequencing(NGS)-related in vitro diagnostic(IVD)reagents and promote high-quality development of the industry,the National Medical Products Administration(NMPA)has issued the Guiding Principles for the Classification Criteria of NGS-Related In Vitro Diagnostic Reagents.This document serves as a critical reference for IVD manufacturers and regulatory personnel in implementing relevant requirements.This article introduces the background of the guideline's development and provides an in-depth interpretation of its key contents,aiming to facilitate accurate understanding and promote consistent classification standards for NGS-related IVD reagents across China.关键词
体外诊断试剂/二代基因测序/分类界定/指导原则/分类管理Key words
in vitro diagnostic(IVD)reagents/next-generation sequencing(NGS)/classification criteria/guiding principles/regulatory classification分类
医药卫生引用本文复制引用
李丽莉,黄杰..《二代基因测序相关体外诊断试剂分类界定指导原则》探讨[J].中国食品药品监管,2025,(8):4-11,8.基金项目
国家重点研发计划项目(2022YFC2409903) （2022YFC2409903）
