醫療器械注冊要多少錢(qián)？醫療器械注冊要多久？是企業(yè)普遍關(guān)心的兩個(gè)問(wèn)題。近日，藥監總局發(fā)布2022年2月審結轉出注冊項目審評用時(shí)情況一覽表，一起來(lái)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.補正資料平均用時(shí)=補正資料總用時(shí)/相關(guān)項目審結轉出總數量

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(zhuān)家咨詢(xún)平均用時(shí)+補正資料平均用時(shí)

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

4.第二和第三類(lèi)產(chǎn)品平均用時(shí)=第二類(lèi)和第三類(lèi)產(chǎn)品用時(shí)/第二類(lèi)和第三類(lèi)產(chǎn)品總數量

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.應急審評用時(shí)不在統計范圍內

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