Gaining market access for medical devices has become increasingly complex, particularly for implantable devices, as regulatory bodies worldwide adopt more stringent evidence requirements. This heightened focus on safety and efficacy ensures robust pre-market evaluations, yet it demands significant investment in clinical research and post-market surveillance by manufacturers.    Securing a position on the Australian Prescribed List represents a critical step for many devices and human tissue products, enabling subsidised access for patients. Achieving this requires not only regulatory approval but also clear demonstration of clinical utility, cost-effectiveness, and alignment with national healthcare priorities. Detailed health economic evaluations, real-world evidence, and comparative studies against existing treatments are often necessary to meet the rigorous requirements for reimbursement.    This presentation explores the intersection of clinical evidence, regulatory compliance, and market access, with a focus on strategies to navigate the evolving landscape. It will address challenges faced by manufacturers in meeting increased evidence demands, the importance of engaging early with regulatory and reimbursement bodies, and the role of health technology assessment (HTA) in decision-making.    Additionally, we will discuss the global shift toward integrated data systems, such as device registries, which can support long-term evidence generation and inform reimbursement decisions. Attendees will gain insights into practical pathways to market access for medical devices, strategies to align clinical research with regulatory and payer expectations, and the critical elements needed to position devices successfully on reimbursement lists.