Abstract: Chondroitin sulfate（ CS） is a major component of the extracellular matrix in living organisms and one of the naturally occurring glycosaminoglycans commonly used in clinical practices. It is an anionic glycosaminoglycan composed of repeating disaccharide units of glucuronic acid （GlcA） and N-acetylgalactosamine （GalNAc）. The hydroxyl groups at different carbon positions on the sugar backbone are typically modified by sulfate groups， and the sulfation patterns vary significantly depending on the tissue sources. This structural diversity underlies the broad applicability of CS across various clinical fields， while also posing challenges for quality control and regulation. Studies have shown that CS has been widely employed in diverse biomedical application fields， such as drug-controlled release systems， tissue repair and regeneration， ophthalmic viscoelastic devices， mucosal protective agents， and artificial skin substitutes. China is a major producer and exporter of CS raw materials. However， systematic research on the development and regulation of CS-based medical devices remains limited. There is a pressing need to establish comprehensive evaluation standards and regulatory frameworks to facilitate the translation of CS-based biomaterials from research to practical application. This article， for the first time， systematically outlines the critical quality attributes （CQAs） of CS-based biomaterials， aiming to provide guidance for innovative R&D， process parameter optimization， quality control， and regulatory oversight of such products.

Key words: Chondroitin sulfate, &emsp, Preparation processes, &emsp, Clinical applications, &emsp, Critical quality attributes