Abstract
<sec> <title>UNSTRUCTURED</title> <p>Breast implants are classified as high-risk implantable medical devices in all major regulatory jurisdictions; however, substantial differences exist in premarket evidence requirements, manufacturing oversight, post-market surveillance obligations, and regulatory enforcement mechanisms. Understanding these differences is increasingly important as manufacturers pursue global market access and regulators strengthen lifecycle governance of implantable devices. This review compares the regulatory frameworks governing breast implants in South Korea, the United States, and the European Union, with particular emphasis on the Korean Ministry of Food and Drug Safety (KMFDS), the U.S. Food and Drug Administration (FDA), and the European Union Medical Device Regulation (EU MDR). The FDA Premarket Approval (PMA) pathway requires extensive clinical evidence, including long-term prospective studies, manufacturing inspections, and mandatory post-approval studies. In contrast, the EU MDR adopts a lifecycle-based regulatory model emphasizing clinical evaluation, post-market surveillance (PMS), post-market clinical follow-up (PMCF), and Unique Device Identification (UDI) systems. Historically, KMFDS approval pathways relied more heavily on technical documentation, biocompatibility testing, and substantial equivalence principles, although recent reforms have strengthened requirements for data integrity, traceability, and post-market oversight. The review further examines differences in quality management systems, manufacturing inspections, registry development, and regulatory responses to breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). While all three jurisdictions increasingly emphasize patient safety and long-term surveillance, their regulatory philosophies differ substantially. The FDA prioritizes rigorous premarket clinical validation, the EU MDR focuses on continuous lifecycle evidence generation, and KMFDS is evolving toward greater alignment with international regulatory standards. These regulatory differences have significant implications for global market entry strategies, clinical evidence generation, post-market risk management, and the international competitiveness of breast implant manufacturers. As regulatory systems continue to evolve toward lifecycle governance, manufacturers must increasingly integrate regulatory compliance, quality management, and long-term clinical evidence into their global development strategies.</p> </sec>