Abstract: As representatives of the third generation of biomedical materials, hydrogels exhibit revolutionary potential in tissue engineering, precision drug delivery, and smart medical devices due to their ability to construct bionic microenvironments. However, the clinical translation of hydrogels is still limited by multidimensional challenges, including biocompatibility, scalability of production, and regulatory complexity. This paper systematically reviews the design innovations, functionalization strategies, and transformational bottlenecks of hydrogel materials, integrating the latest technological trends, such as 4D printing and AI-driven design. We propose a collaborative optimization pathway encompassing materials, technology, clinical applications, and policy. By introducing local Chinese innovation cases and monitoring scientific advancements, this study offers solutions that possess both academic significance and practical guidance for the clinical translation of hydrogels.