三類(lèi)醫療器械經(jīng)營(yíng)許可證如何辦理
1、三類(lèi)醫療器械經(jīng)營(yíng)許可證辦理方式如下：
（1）申請人提交申請資料到相關(guān)部門(mén)；
（2）相關(guān)部門(mén)受理申請人的申請；
（3）到實(shí)際場(chǎng)地進(jìn)行勘察以及對產(chǎn)品進(jìn)行審核；
（4）準予頒發(fā)三類(lèi)醫療器械許可證。

三類(lèi)醫療器械作為目前醫療器械分類(lèi)中危險性最高的品類(lèi)，嚴格受到相關(guān)部門(mén)的監督和管理，對于很多經(jīng)營(yíng)三類(lèi)醫療器械的家人們來(lái)說(shuō)，很多基礎性問(wèn)題還不能完全掌握，今天我們就來(lái)看一看，三類(lèi)醫療器械經(jīng)營(yíng)范圍有哪些？又該如何申請三類(lèi)醫療器械經(jīng)營(yíng)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!

申請與受理

企業(yè)登陸北京市食品藥品監務(wù)管理局企業(yè)服務(wù)平臺進(jìn)行網(wǎng)上申報，企業(yè)根據受理范圍的規定，需提交以下申請材料:

1.《醫療器劃經(jīng)營(yíng)許可延續申請表》;

2、營(yíng)業(yè)執照和組織機構代碼證復印件;(交驗原件)

3.《醫療器成經(jīng)營(yíng)許可證》復印件;(交驗原件)

4.法定代表人、企業(yè)負責人、質(zhì)量負責人的身份證明、學(xué)歷或者職稱(chēng)證明氣印件:(交驗百件)

5.組織機構與部門(mén)設置說(shuō)明;

6.經(jīng)營(yíng)場(chǎng)所和庫房的房屋產(chǎn)權。使用權證明;跨銷(xiāo)區設庫的，應提交《醫療器材經(jīng)營(yíng)企業(yè)跨轉區設置庫房備案表》;委托貯存的，應提交含有明確雙方質(zhì)量責任