Thrombotic and hemorrhagic diseases have become the leading cause of death globally

with early

accurate

and stratified diagnosis being critical for clinical management. China's in vitro diagnostics (IVD) industry is currently in a period of rapid growth

yet high-end coagulation and hemostasis testing reagents remain heavily dependent on imports

and routine tests fail to meet the demands of precision medicine. This article

guided by clinical application principles

introduces key parameters such as protein C

protein S

vWF factor

and monitoring of novel anticoagulants. It elucidates the development design rationale and key technical points of reagents

product evaluation methods

and proposes a comprehensive industrialization strategy encompassing raw material procurement

production processes

quality control

registration

marketing

and continuous improvement. Feasible solutions for domestic substitution and technological upgrading are also proposed. The study demonstrates that colorimetric substrate-based and coagulation-based methods can achieve internationally comparable levels of accuracy in key factor activity and serum drug concentration detection. Establishing an industrialization model of "R&D–production–registration–market–after-sales" will facilitate the localization of high-end coagulation reagents

reduce clinical costs

and improve disease diagnosis rates. This research lays the foundation and accumulates experience for the development and industrial application of thrombotic and hemostatic IVD products

promoting the autonomous and healthy development of China's IVD industry.