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

三類(lèi)醫(yī)療器械作為目前醫(yī)療器械分類(lèi)中危險(xiǎn)性最高的品類(lèi)，嚴(yán)格受到相關(guān)部門(mén)的監(jiān)督和管理，但是對(duì)于很多經(jīng)營(yíng)三類(lèi)醫(yī)療器械的家人們來(lái)說(shuō)，很多基礎(chǔ)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(yī)療器械經(jīng)營(yíng)范圍有哪些？又該如何申請(qǐng)三類(lèi)醫(yī)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!

總體來(lái)說(shuō)，醫(yī)療器械經(jīng)營(yíng)許可證的辦理過(guò)程雖然略顯繁瑣，但明確了需要提交的材料和審核標(biāo)準(zhǔn)，為醫(yī)療器械經(jīng)營(yíng)市場(chǎng)注入了必要的規(guī)范，有助于保護(hù)患者的權(quán)益和安全。

二、辦理程序:

1、開(kāi)辦第二、三類(lèi)醫(yī)療器體經(jīng)營(yíng)企業(yè)，應(yīng)向經(jīng)營(yíng)所在地食品藥品監(jiān)管分局申請(qǐng)并提交以下資料

(1)、《北京市醫(yī)療器材經(jīng)營(yíng)企業(yè)許可證申請(qǐng)表》;

(2)、《醫(yī)療器材經(jīng)營(yíng)企業(yè)許可證申請(qǐng)材料登記表》;

(3)、工商行改管理部門(mén)出具的企業(yè)名稱(chēng)預(yù)技準(zhǔn)證明文件成《營(yíng)業(yè)執(zhí)照》氣印件(校驗(yàn)口件);