Regulatory science for medical devices aims to develop new tools, standards and approaches to assess the safety, effectiveness, quality and performance of medical devices. In the field of biomaterials, hernia mesh is a class of implants that have been successfully translated to clinical applications. With a focus on hernia mesh and its regulatory science system, this paper collected and reviewed information on hernia mesh products and biomaterials in both Chinese and American markets. The current development of regulatory science for hernia mesh, including its regulations, standards, guidance documents and classification, and the scientific evaluation of its safety and effectiveness was first reported. Then the research prospect of regulatory science for hernia mesh was discussed. New methods for the preclinical animal study and new tools for the evaluation of the safety and effectiveness of hernia mesh, such as computational modeling, big data platform and evidence-based research, were assessed. By taking the regulatory science of hernia mesh as a case study, this review provided a research basis for developing a regulatory science system of implantable medical devices, furthering the systematic evaluation of the safety and effectiveness of medical devices for better regulatory decision-making. This was the first article reviewing the regulatory science of hernia mesh and biomaterial-based implants. It also proposed and explained the concepts of evidence-based regulatory science and technical review for the first time.

Rheumatoid arthritis (RA) is a systemic autoimmune disease characterized by chronic synovial inflammation, synovial hyperplasia, and progressive joint destruction and remains a major clinical challenge. Polysaccharide-derived delivery platforms have attracted widespread attention for RA precision therapy owing to their natural origin, excellent biocompatibility, and tailorable functionality; however, existing reviews generally focus on single material or carrier types and provide limited cross-comparison of carrier architectures and translational considerations. This review systematically evaluates recent advances in polysaccharide derivative design strategies and delivery system innovations for RA management. We first elaborate on how chemical modifications confer multi-responsive properties (pH-, reactive oxygen species [ROS]-, and enzyme-triggered release) and how diversified morphologies (hydrogels, microspheres, microneedles, vesicles) enable spatiotemporally controlled drug delivery in inflamed joints. Critical analysis highlights several translational barriers, including limited in vivo retention, insufficient pharmacokinetic and biodistribution data, and challenges associated with scale-up manufacturing and reproducibility. Looking forward, future development should integrate biomimetic design, rational multi-component optimization, and advanced manufacturing technologies to improve the stability, controllability, and translational feasibility of polysaccharide-based RA delivery systems. This review provides an integrated, translation-focused perspective that bridges material engineering and clinical pathological demands, guiding the development of next-generation polysaccharide-based RA therapies.