Abstract: This article focuses on the legal transformation of medical ethics in China during the new era of socialism with Chinese characteristics, since the 18th National Congress of the Communist Party of China. By employing diachronic review and normative analysis, it systematically presents the internal logic and practical pathways of the field’s evolution from fragmented self-regulation to integrated governance. Academically, the discipline has advanced through four stages: theoretical foundation and foreign introduction, practical shift and institutional exploration, critical reflection and systemic optimization, and legal-led, full-coverage advancement. Legally, a refined regulatory system has been established, centered on national laws and supported by specialized review regulations. In governance, a transition from passive response to proactive shaping has been achieved, with ethical review expanding across all domains of life science research, and procedural management and accountability fully incorporated into the rule of law. Looking ahead, it is essential to balance institutional rigidity with practical flexibility, contribute ethical wisdom to the Healthy China initiative, and offer a Chinese solution to global science and technology ethics governance.