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!

平面圖（注明面積）和與被委托方簽署的書(shū)面協(xié)議復印件、被委托方的《醫療器械經(jīng)營(yíng)許可證》復印件） 6．經(jīng)營(yíng)設施、設備目錄； 7．經(jīng)營(yíng)質(zhì)量管理制度、工作程序等文件目錄； 8．計算機信息管理系統基本情況介紹和功能說(shuō)明； 9．凡申請企業(yè)申報材料時(shí)，具體辦理人員不是法定代表人或負責人本人，企業(yè)應當提交《 授權委托書(shū)》；10．申報材料真實(shí)性自我保證聲明，并對材料作出如有虛假承擔法律責任的承諾。