外购取证的产品做成组合包，自己需要做临床吗

如愿1

我中心静脉导管包，外购别人已经取证的导管包里面的导管，，，自己包装成组合包，，，自己需要做临床吗？因为查询免临床目录，导管没有免临床
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ldt2008

公司 A 研发注册产品 W 时是否需要做临床，需依据具体情况判断：

通常情况需进行临床评价。例如，产品 W 中的中心静脉导管与已上市的同品种医疗器械相比，工作机理明确、设计定型，生产工艺成熟，已上市的同品种医疗器械临床应用多年且无严重不良事件记录，并且公司 A 未改变其常规用途；或者公司 A 通过非临床评价，如对产品的物理性能、化学性能、生物相容性、生物安全性等方面的研究，能够证明产品 W 中的中心静脉导管安全、有效。：根据《医疗器械注册与备案管理办法》规定，除特定情形外，医疗器械产品注册、备案，应当进行临床评价。如果公司 A 的产品 W “组合包” 中的中心静脉导管不属于免于进行临床评价的情形，且通过非临床评价无法证明该医疗器械安全、有效，那么通常应当开展临床试验，以确认其在适用范围内的安全性和有效性。
特殊情况可免于临床评价：若公司 A 能证明产品 W 符合以下情况，则有可能免于进行临床评价。例如，产品 W 中的中心静脉导管与已上市的同品种医疗器械相比，工作机理明确、设计定型，生产工艺成熟，已上市的同品种医疗器械临床应用多年且无严重不良事件记录，并且公司 A 未改变其常规用途；或者公司 A 通过非临床评价，如对产品的物理性能、化学性能、生物相容性、生物安全性等方面的研究，能够证明产品 W 中的中心静脉导管安全、有效。

虽然公司 B 的导管已取证，但组合成产品 W “组合包” 后，公司 A 需按照相关法规和指导原则的要求，对产品 W 整体进行评估，以确定是否需要开展临床试验。建议公司 A 咨询当地省药品监督管理部门，以获取更准确的指导。