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)負責人、質(zhì)量管理人身份證跟畢業(yè)證原件及復印件、職稱證明

3. 辦公室房產(chǎn)證、租賃合同復印件；

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

五、驗收之前需要注意的事項：

房子：

1.面積達到要求。

2. 辦公室設備設施齊全（辦公桌椅、文件柜、電腦、打印機、固定網(wǎng)絡等辦公設備）

3.門牌號、門牌logo

4.現(xiàn)場與平面圖一致；

5.不能有家居用品；

6.庫房要是空置狀態(tài)

7.擺放地拍或者貨架，溫濕度計，粘鼠板，滅火器，空調(diào)等

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evices 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 square meters in office, 40 square meters in warehouse, 20 cubic meters in cold chain. All products remain: 30 square meters in office, 40 square meters in warehouse For the three types of medical devices, what materials do you need to deliver them? Original copy of the business license, official seal Original and copy of id card of legal person, enterprise responsible pe