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)出注冊項目審評用時情況一覽表，一起來看一下。
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(guān)項目審結(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=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(chǎn)品平均用時=第二類和第三類產(chǎn)品用時/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)急審評用時不在統(tǒng)計范圍內(nèi)
Time of emergency review is out of the scope of this statistics.