{"id":1018,"slug":"这种svf干细胞丰胸在中国大陆的正规医院能做吗-国内是怎么管的","question":"这种SVF干细胞丰胸在中国大陆的正规医院能做吗？国内是怎么管的？","intent":"local","language":"zh","url":"https://worldwiki.io/q/这种svf干细胞丰胸在中国大陆的正规医院能做吗-国内是怎么管的","entity":{"slug":"svf-breast-augmentation","name":"SVF Breast Augmentation","url":"https://worldwiki.io/entity/svf-breast-augmentation"},"answer":{"short_answer":"本词条所依据的资料中<strong>不包含</strong>中国大陆对脂肪来源SVF用于美容性丰胸的监管认定，因此这里不做判断。可以作为参照的是：美国FDA认为脂肪来源SVF不符合「最小操作」标准，须按药品/生物制品走IND或已批准的BLA路径；韩国则自2025年2月21日起要求再生医疗治疗在指定机构、经审议委员会批准后实施。国内是否可做、以何种身份可做，应直接向国家卫生健康委员会、国家药品监督管理局的公开文件以及拟就诊的三级医院核实，不要以境外机构的宣传作为依据。","detailed_answer":"<p>可核查的两条境外参照：</p><ul><li><strong>美国</strong>：FDA认定脂肪来源SVF未通过21 CFR 1271.10(a)(1)的最小操作判定，需作为药品/生物制品申报。<sup>[6]</sup></li><li><strong>韩国</strong>：2025年2月21日起施行的法规修订，将再生医疗治疗限定于重症、罕见或难治性疾病，在指定机构内经审议委员会批准治疗方案后实施。<sup>[8]</sup></li></ul><p>向国内机构询问时可以问三件具体的事：该细胞处理过程属于何种性质的医疗行为、有无相应的备案或批件编号、能否提供可查证的文件。对方若只提供宣传册而无可核查编号，应视为未获答复。</p>","format":"paragraph","confidence":55,"verified_at":null,"updated_at":"2026-09-20 17:11:10"},"sources":[{"id":282,"title":"Warning Letter: US Stem Cell Clinic, LLC (524470)","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/us-stem-cell-clinic-llc-524470-08242017","publisher":"U.S. Food and Drug Administration","type":"government","accessed_at":"2026-09-19 18:00:44"},{"id":93,"title":"첨단재생의료에 대한 환자 접근성은 향상되고, 안전관리는 강화됩니다","url":"https://mohw.go.kr/board.es?mid=a10503000000&bid=0027&list_no=1483481&act=view","publisher":"보건복지부","type":"government","accessed_at":"2026-09-18 18:00:38"},{"id":283,"title":"SCOTUS Declines Stem Cell Case, Upholding FDA Oversight of Cell Therapies","url":"https://www.aabb.org/news-resources/news/article/2025/10/15/scotus-declines-stem-cell-case--upholding-fda-oversight-of-cell-therapies","publisher":"AABB (Association for the Advancement of Blood & Biotherapies)","type":"organization","accessed_at":"2026-09-19 18:00:45"}],"published_at":"2026-09-20 08:11:10"}