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国家药品监督管理局
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国家药监局关于发布优化全生命周期监管支持高端 ...
一、优化特殊审批程序 对符合要求的国内首创、国际领先,且具有显著临床应用价值的高端医疗器械继续实施创新特别审查,进一步优化创新审查工作,加强申请人和审查专家的沟通,强化对创新医疗器械研发和注册的技术指导。对高端创新医疗器械变更注册,按照创新特别审查程序开展审查 ...
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