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；）

五、驗收之前需要注意的事項：

房子：

1.面積達(dá)到要求。

2. 辦公室設(shè)備設(shè)施齊全（辦公桌椅、文件柜、電腦、打印機(jī)、固定網(wǎng)絡(luò)等辦公設(shè)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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三類醫(yī)療器械經(jīng)營許可證辦理流程及條件

國家對經(jīng)營和銷售醫(yī)療器械的企業(yè)按照風(fēng)險程度分為三類進(jìn)行管理，這也就導(dǎo)致很多人認(rèn)為醫(yī)療器械經(jīng)營許可證也分為三類.

 ownership certificate and lease contract; Copy of the property ownership certificate and lease contract; (for the three parties, copy of the logistics , property right certificate and lease contract, copy of logistics service agreement and assurance agreement;) 5. Note before acceptance: house: 1. The area meets the re 2. Complete office e and facilities (office desks and chairs, file cabinets, computers, printers, fixed network and other office e) 3. Door plate number and door plate logo 4. The site is consistent with the floor plan; 5. No household items; 6. If the warehouse is empty 7. Put floor photos or shelves, hygrometer, sticky mouse board, fire extinguisher, air conditioning, etc about the handling of medical devices is not clear, you can contact me at any time, more than ten years of business focus on the handling of medical devices, Beijing district policy is very understanding, full of experience, for you to solve a variety of difficult problems!!! Procedures and conditions for handling the business license of Class III medical devices The state manages the enterprises that operate and sell medical devices into three categories according to the risk degree,