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+轉讓 |
單價: | 2500.00元/件 |
發(fā)貨期限: | 自買家付款之日起 天內發(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 19:16 |
最后更新: | 2023-12-14 19:16 |
瀏覽次數(shù): | 201 |
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三類醫(yī)療器械經營許可證如何辦理
1、三類醫(yī)療器械經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)療器械經營范圍有哪些?又該如何申請三類醫(yī)療器械經營許可證!
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!
總體來說,醫(yī)療器械經營許可證的辦理過程雖然略顯繁瑣,但明確了需要提交的材料和審核標準,為醫(yī)療器械經營市場注入了必要的規(guī)范,有助于保護患者的權益和安全。
二、辦理程序:
1、開辦第二、三類醫(yī)療器體經營企業(yè),應向經營所在地食品藥品監(jiān)管分局申請并提交以下資料
(1)、《北京市醫(yī)療器材經營企業(yè)許可證申請表》;
(2)、《醫(yī)療器材經營企業(yè)許可證申請材料登記表》;
(3)、工商行改管理部門出具的企業(yè)名稱預技準證明文件成《營業(yè)執(zhí)照》氣印件(校驗口件);