江苏省政府办公厅印发《关于全面推进药品医疗器械监管深层次改革促进医药产业高质量发展若干政策措施的通知》。《通知》提到,符合条件的集团企业在境内已注册产品来苏申报的,5个工作日内完成技术审评。简化低风险类别产品注册申报资料。第二类医疗器械拟上市注册与生产许可申报并联审评审批,延续、变更注册事项合并办理。有源类医疗器械平均检验时限由85个工作日缩短为60个工作日。
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