{"id":1096,"slug":"怎么核验一家韩国细胞存储机构是不是有正规资质","question":"怎么核验一家韩国细胞存储机构是不是有正规资质？","intent":"local","language":"zh","url":"https://worldwiki.io/q/怎么核验一家韩国细胞存储机构是不是有正规资质","entity":{"slug":"cell-banking","name":"Cell Banking","url":"https://worldwiki.io/entity/cell-banking"},"answer":{"short_answer":"韩国有两类不同的许可。家庭脐带血库须依据《脐带血管理及研究法》取得保健福祉部长官许可，并满足设施、设备、人员和质量管理要求；细胞处理则须依据《尖端再生生物法》第15条取得MFDS的细胞处理设施许可，每3年换发一次。请要求机构出示对应许可的名称、编号和有效期，并注意两者不能互相替代。","detailed_answer":"<p>核验时可按下表对照：</p><table><tr><th>业务</th><th>主管机关</th><th>依据</th><th>有效期</th></tr><tr><td>家庭（自体）脐带血库</td><td>保健福祉部长官</td><td>제대혈 관리 및 연구에 관한 법률</td><td>法规规定的设施、设备、人员、质量管理要求</td></tr><tr><td>细胞处理（分离、冻存等）</td><td>食品医药品安全处（MFDS）</td><td>첨단재생바이오법 제15조</td><td>每3年换发</td></tr></table><p>常见误区：把\"公司在韩国注册\"\"医院有诊疗资质\"当成细胞处理许可。三者是不同的东西，应分别索取书面凭证。</p>","format":"paragraph","confidence":75,"verified_at":null,"updated_at":"2026-09-20 17:11:10"},"sources":[{"id":262,"title":"제대혈 관리 및 연구에 관한 법률 (Act on Cord Blood Management and Research, Law No. 10130)","url":"https://ko.wikisource.org/wiki/%EC%A0%9C%EB%8C%80%ED%98%88_%EA%B4%80%EB%A6%AC_%EB%B0%8F_%EC%97%B0%EA%B5%AC%EC%97%90_%EA%B4%80%ED%95%9C_%EB%B2%95%EB%A5%A0","publisher":"Wikisource (Korean) – statutory text","type":"other","accessed_at":"2026-09-19 18:00:29"},{"id":88,"title":"첨단재생의료 및 첨단바이오의약품 안전 및 지원에 관한 법률 제15조(첨단재생의료세포처리시설)","url":"https://casenote.kr/%EB%B2%95%EB%A0%B9/%EC%B2%A8%EB%8B%A8%EC%9E%AC%EC%83%9D%EC%9D%98%EB%A3%8C_%EB%B0%8F_%EC%B2%A8%EB%8B%A8%EB%B0%94%EC%9D%B4%EC%98%A4%EC%9D%98%EC%95%BD%ED%92%88_%EC%95%88%EC%A0%84_%EB%B0%8F_%EC%A7%80%EC%9B%90%EC%97%90_%EA%B4%80%ED%95%9C_%EB%B2%95%EB%A5%A0/%EC%A0%9C15%EC%A1%B0","publisher":"CaseNote (법령 원문)","type":"other","accessed_at":"2026-09-19 18:01:23"},{"id":94,"title":"첨단재생의료 및 첨단바이오의약품 안전 및 지원에 관한 법률의 개정 및 시행과 그 시사점","url":"https://www.shinkim.com/kor/media/newsletter/2728","publisher":"법무법인(유) 세종","type":"industry","accessed_at":"2026-09-19 18:01:25"}],"published_at":"2026-09-20 08:11:10"}