医疗器械注册要多少钱？医疗器械注册要多久？是企业普遍关心的两个问题。近日，药监总局发布2022年2月审结转出注册项目审评用时情况一览表，一起来看一下。

备注：

1.本表涉及时间均为工作日。

The time in this table is working days.

2.补正资料平均用时=补正资料总用时/相关项目审结转出总数量

average time of deficiency response = total time of deficiency response /total number of completed and transferred submissions with deficiencies.

3.总用时=审评平均用时+专家咨询平均用时+补正资料平均用时

Total time = average review time+ average time of expert consultation + average time of deficiency response.

4.第二和第三类产品平均用时=第二类和第三类产品用时/第二类和第三类产品总数量

Average time for Class II and III products = total treview time of class II and III products/the total number of class II and III product submissions.

5.应急审评用时不在统计范围内

Time of emergency review is out of the scope of this statistics.