GB/T 44672-2024/ISO 21151:2020 In vitro diagnostic medical devices-Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples, was released on September 29th, 2024 and came into effect on April 1st, 2025. This standard addresses the need for harmonisation protocols organized and implemented by international bodies in cases where reference measurement procedures, suitable certified reference materials, or internationally agreed calibrators are lacking. By defining the highest achievable level of metrological tracerability for a specified measurand, the standard aims to achieve equivalence of results from different in vitro diagnostic medical devices (IVD MD). This article interprets the core content of the standard and elucidates the value of harmonization schemes in enhancing the comparability of measurement results and promoting result interoperability. The interpretation of this standard will assist clinical laboratories and IVD manufacturers in China in establishing and improving traceability paths based on harmonization schemes in practice, thereby establishing a solid foundation for result consistency across different systems and platforms and homogeneity in clinical decision-making.