醫(yī)療器械注冊要多少錢？醫(yī)療器械注冊要多久？是企業(yè)普遍關(guān)心的兩個(gè)問題。近日，藥監(jiān)總局發(fā)布2022年2月審結(jié)轉(zhuǎn)出注冊項(xiàng)目審評用時(shí)情況一覽表，一起來看一下。

備注：

1.本表涉及時(shí)間均為工作日。

The time in this table is working days.

2.補(bǔ)正資料平均用時(shí)=補(bǔ)正資料總用時(shí)/相關(guān)項(xiàng)目審結(jié)轉(zhuǎn)出總數(shù)量

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

3.總用時(shí)=審評平均用時(shí)+專家咨詢平均用時(shí)+補(bǔ)正資料平均用時(shí)

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

4.第二和第三類產(chǎn)品平均用時(shí)=第二類和第三類產(chǎn)品用時(shí)/第二類和第三類產(chǎn)品總數(shù)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.應(yīng)急審評用時(shí)不在統(tǒng)計(jì)范圍內(nèi)

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