国家医疗器械体外诊断产业计量测试中心获批筹建

Core Viewpoint - The establishment of the National Medical Device In Vitro Diagnostic Industry Metrology Testing Center aims to enhance the quality development of the in vitro diagnostic industry in China by addressing existing metrology challenges and supporting domestic substitution and international competitiveness [1] Industry Challenges - The in vitro diagnostic industry in China currently faces several metrology challenges, including a lack of measurement standards, difficulties in testing core components, insufficient measurement capabilities for high-end diagnostic equipment, and incomplete establishment of measurement methods and testing capabilities [1] Center Objectives - The National Medical Device In Vitro Diagnostic Industry Metrology Testing Center will focus on the localization and high-end development of in vitro diagnostic reagents and equipment, emphasizing research on key common technologies within the industry [1] Technological Advancements - The center plans to utilize advanced intelligent and digital technologies to conduct research on 15 innovative metrology testing methods, including the traceability of semi-quantitative test results for serum indices and the rapid measurement of temperature for PCR analyzers [1] Industry Support - The center aims to resolve critical bottlenecks in the supply chain of key raw materials through metrology testing, support lifecycle management, and promote technological innovation and upgrades in the in vitro diagnostic industry, thereby providing reliable technical support for precision medicine [1]