醫療器械注冊要多少錢？醫療器械注冊要多久？是企業普遍關心的兩個問題。近日，藥監總局發布2022年2月審結轉出注冊項目審評用時情況一覽表，一起來看一下。
備注：
1.本表涉及時間均為工作日。
The time in this table is working days.
2.補正資料平均用時=補正資料總用時/相關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=審評平均用時+專家咨詢平均用時+補正資料平均用時
Total time = average review time+ average time of expert consultation + average time of deficiency response.
4.第二和第三類產品平均用時=第二類和第三類產品用時/第二類和第三類產品總數量
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.應急審評用時不在統計范圍內
Time of emergency review is out of the scope of this statistics.