二,、辦理醫(yī)療器械三類經(jīng)營許可證的流程是什么？

1. 提交申請

2. 窗口受理

3. 審核材料

4. 老師下戶現(xiàn)場檢查

5. 審批通過

6. 領(lǐng)取醫(yī)療器械三許可證

一,、什么是醫(yī)療器械,？

醫(yī)療器械：是指單獨(dú)或者組合使用于人體的儀器、設(shè)備,、器具,、材料或者其他物品，包括所需要的軟件,；其用于人體體表及體內(nèi)的作用不是用藥理學(xué),、免疫學(xué)或者代謝的手段獲得，但是可能有這些手段參與并起一定的輔助作用,。

二,、醫(yī)療器械分幾類,？

一共三類：

經(jīng)營第一類醫(yī)療器械不需許可和備案，執(zhí)照上面加上銷售醫(yī)療器械一類就可以正常銷售,；

經(jīng)營第二類醫(yī)療器械需要辦理備案；

經(jīng)營第三類醫(yī)療器械需要辦理經(jīng)營許可證,。

三,、辦公室和庫房需要多大面積？

根據(jù)最新法規(guī)要求：

6840體外診斷試劑含冷鏈：辦公室30平,，庫房40平,，冷鏈20立方米
剩下所有產(chǎn)品都是：辦公室30平，庫房40平

四,、辦理醫(yī)療器械三類,，交件需要哪些材料？

1. 營業(yè)執(zhí)照副本原件,，公章

2. 法人,、企業(yè)負(fù)責(zé)人、質(zhì)量管理人身份證跟畢業(yè)證原件及復(fù)印件,、職稱證明

3. 辦公室房產(chǎn)證,、租賃合同復(fù)印件；

4. 庫房房產(chǎn)證,、租賃合同復(fù)印件,；（委托三方儲(chǔ)存的，需要三方物流資質(zhì)復(fù)印件,、庫房的產(chǎn)權(quán)證明和租賃合同復(fù)印件,、物流服務(wù)協(xié)議和質(zhì)量保證協(xié)議復(fù)印件；）

e inspection Approval passed Get the medical device license 3 1. What is a medical device? Medical devices: refers to instruments, e, appliances, materials or other articles used individually or in combination, including required software; their use in the body is not obtained by pharmacological, immunology or metabolic means, but may participate and play a certain auxiliary role. 2. How many categories are medical devices divided into? There are three categories: The operation of the first type of medical devices does not need permission and record, the license plus the sales of medical devices can be sold normally; The operation of type II medical devices needs to be put on record; The operation of the third type of medical e requires the operation license. How much area does the office and the warehouse need? According to the latest regulatory re: 6840 In vitro diagnostic reagent includes cold chain: 30 squar