1
follow
453
views

创面敷贴产品预期用途与《医疗器械分类目录》一致,但是申报产品中含有高分子材料,是否可以豁免临床评价?

You haven't logged in yet! only 1 answers can be viewed temporarily

go Sign in! No accountgoregister

Alone 一阶会员 User from: 广东省深圳市
2024-09-09 22:54

应根据产品的具体材料确定。如产品不超过《免于临床评价医疗器械目录(2023年)》所述范围,且已有与拟申报产品具有等同性的同类产品上市,则可以豁免临床评价。如果拟申报产品与目录或已上市产品存在差异,应考虑对差异部分进行评价,必要时进行临床评价或开展临床试验。


About the author

冒牌货 二阶会员

This guy is lazy,Introduction has not been set

Problem dynamics

Release time
2024-09-09 22:51
Update time
2024-09-09 22:54
Focused
1 people pay attention to