三類醫(yī)療: | 許可證注冊 |
二類醫(yī)療器械: | 二類備案 |
二類三類許可證: | 注冊+轉(zhuǎn)讓 |
單價: | 2500.00元/件 |
發(fā)貨期限: | 自買家付款之日起 天內(nèi)發(fā)貨 |
所在地: | 直轄市 北京 北京昌平 |
有效期至: | 長期有效 |
發(fā)布時間: | 2023-12-14 16:51 |
最后更新: | 2023-12-14 16:51 |
瀏覽次數(shù): | 101 |
采購咨詢: |
請賣家聯(lián)系我
|
三類醫(yī)療器械經(jīng)營許可證如何辦理
1、三類醫(yī)療器械經(jīng)營許可證辦理方式如下:
(1)申請人提交申請資料到相關部門;
(2)相關部門受理申請人的申請;
(3)到實際場地進行勘察以及對產(chǎn)品進行審核;
(4)準予頒發(fā)三類醫(yī)療器械許可證。
三類醫(yī)療器械作為目前醫(yī)療器械分類中危險性最高的品類,嚴格受到相關部門的監(jiān)督和管理,但是對于很多經(jīng)營三類醫(yī)療器械的家人們來說,很多基礎性問題還不能完全掌握,今天我們就來看一看,三類醫(yī)療器械經(jīng)營范圍有哪些?又該如何申請三類醫(yī)療器械經(jīng)營許可證!
handle the business license of class III medical devices
1. The business license of Class III medical devices is handled as follows:
(1) The applicant shall submit the application materials to the relevant departments;
(2) Relevant departments shall accept the application of the applicant;
(3) Investigate the actual site and audit the products;
(4) Grant the issuance of a class III medical device license.
Three kinds of medical devices as the highest risk in the medical device classification category, strictly by the supervision and management, but for many families of three kinds of medical devices, many basic problems is not fully grasp, today we will take a look, what are three business scope of medical devices? How to apply for the three types of medical e business license again!
準備申請材料
根據(jù)相關法規(guī)和政策的要求,準備申請材料,可能包括但不限于以下內(nèi)容:
1.三個相關醫(yī)學專業(yè)畢業(yè)的大專以上(含大專)文憑產(chǎn)品質(zhì)量監(jiān)督檢測人員(其中一個為質(zhì)量檢測負責人)
2.三個質(zhì)量監(jiān)督檢測人員的身份證和畢業(yè)證復印件、工作簡歷;
3.所銷售醫(yī)療器械對方生產(chǎn)廠家的公司營業(yè)執(zhí)照、醫(yī)療器械生產(chǎn)企業(yè)許可證;
4.所銷售醫(yī)療器械對方生產(chǎn)廠家的醫(yī)療器械注冊證、醫(yī)療器械注冊登記表;
5.所銷售醫(yī)療器械對方生產(chǎn)廠家的委托銷售授權(quán)書。