《生物医学新技术临床研究和临床转化应用管理条例》 （以下简称《条例》）的颁布是我国生物医学新技术监管史上的里程碑，标志着该领域正式迈入"宽进、严出、强监管"的治理新阶段。本文基于笔者在干细胞临床研究和临床转化领域的长期实践，对《条例》的立法背景、核心框架与治理逻辑进行系统性剖析与深度思考。《条例》所确立的"宽进"，其本质乃程序性门槛简化与实质性责任强化的辩证统一；其所强调的"严出"，通过国家级"双评估"机制与全周期动态监管，为临床转化构筑坚实的质量与伦理防线；其所依托的"强监管"，则通过赋予实质性执法权、设定梯度化法律责任及推行个人"双罚制"，构建贯穿全程的责任链条与威慑体系。值得注意的是，《条例》彻底疏通干细胞治疗"双轨制"中的医疗技术路径，并通过"三阶段、双审查、双评估"（即"3+2+2"）监管框架，为技术创新与转化提供了清晰路径。然而，作为一部框架性立法，《条例》在审查机制、评估主体资质、临床应用准入标准及技术产品分类界定等关键环节的配套细则仍待明确，其落地仍面临从"文本"到"实践"的挑战。基于此，本文从医疗机构、企业及监管协同等多维视角，提出具有可操作性的系统实施建议，强调各方需前瞻布局、夯实内功、协同共建，方能将政策机遇转化为临床价值，共同推动我国生物医学新技术产业在规范中创新、在监管下突破。

The promulgation of the "Regulations on the Clinical Research and Clinical Translation Application of New Biomedical Technologies" (hereinafter referred to as the "Regulations") constitutes a milestone in the history of regulating new biomedical technologies in China, marking the formal entry of this field into a new stage of rule-of-law characterized by "lenient entry, strict exit, and strong supervision". Based on the author's long-term practice experience in the field of clinical research and clinical transformation of stem cells, this article provides a systematic analysis and deep thinking on the legislative background, core framework, and underlying governance logic of the "Regulations". The article points out that the "lenient entry" established by the "Regulations" is, in essence, a dialectical unity of simplified procedural thresholds and strengthened substantive responsibilities. The "strict exit" emphasized by the "Regulations" builds a solid quality and ethical defense line for clinical translation through a national-level "dual-evaluation" mechanism and whole-cycle dynamic supervision. The "strong supervision" it relies on constructs a whole-process, clear-responsibility chain and deterrent system by granting substantive enforcement powers, establishing graded legal liabilities, and implementing a "dual punishment" system for individuals. Particularly importantly, the "Regulations" thoroughly unblock the medical technology pathway within the "dual-track" system for stem cell therapy, and provide clear guidance for technological innovation and translation through the "three stages, dual reviews, dual evaluations" (i.e., "3+2+2") regulatory framework. However, as a framework legislation, the supporting rules and technical guidelines for key links such as the review mechanism, qualification of assessment bodies, clinical application access standards, and the classification criteria of technologies and products in the "Regulations" still need to be clarified, and its implementation still faces challenges from "text" to "practice". Based on this, from the multiple perspectives of medical institutions, enterprises, and regulatory coordination, this article proposes systematic and actionable implementation suggestions, emphasizing that all parties need to plan ahead, consolidate internal capabilities, and collaborate to build together, in order to translate policy opportunities into clinical value, and jointly promote the standardized, safe, and efficient development of China's new biomedical technology industry.