Abstract
<sec> <title>UNSTRUCTURED</title> <p>Background: The successful reintroduction of high-risk implantable medical devices following major regulatory non-compliance remains a significant challenge for manufacturers, regulators, healthcare professionals, and patients. Existing regulatory frameworks primarily focus on safety, efficacy, manufacturing quality, and post-market surveillance. However, restored regulatory approval does not necessarily translate into restored stakeholder confidence or sustainable market access. Objective: To propose the concept of the Regulatory Trust Gap and to examine its implications for the global market re-entry of high-risk implantable medical devices following major regulatory failure. Methods: This perspective article presents a conceptual regulatory science framework informed by published scientific literature, publicly available regulatory documents, international medical device governance principles, and comparative analysis of major regulatory jurisdictions, including the United States Food and Drug Administration (FDA), the European Union Medical Device Regulation (EU MDR), China's National Medical Products Administration (NMPA), and the Korean Ministry of Food and Drug Safety (KMFDS). The BellaGel breast implant case is used as an illustrative example to explore the relationship between regulatory approval, stakeholder confidence, and long-term market sustainability. Results: We propose the Regulatory Trust Gap as the discrepancy between restored regulatory authorization and restored stakeholder confidence after major regulatory non-compliance. This gap may persist even after a device has regained legal authorization for commercialization. The proposed framework identifies several interrelated determinants of regulatory trust, including manufacturing integrity, regulatory compliance history, transparency, independent clinical evidence, post-market surveillance performance, and corporate governance. Comparative analysis suggests that these factors may substantially influence physician acceptance, hospital procurement decisions, reimbursement considerations, international regulatory review, and commercial sustainability across global markets. Conclusions: Regulatory approval should not be considered equivalent to successful market recovery following major compliance failures. We propose that regulatory trust functions as a critical intermediate determinant between regulatory authorization and sustainable global market access. The Regulatory Trust Gap framework may provide a useful conceptual model for evaluating re-entry strategies for high-risk implantable medical devices and for advancing future research in regulatory science, medical device governance, and international market access.</p> </sec>