二、醫療器械分幾類？

一共三類：

經營第一類醫療器械不需許可和備案，執照上面加上銷售醫療器械一類就可以正常銷售；

經營第二類醫療器械需要辦理備案；

經營第三類醫療器械需要辦理經營許可證。

三、辦公室和庫房需要多大面積？

根據最新法規要求：

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
剩下所有產品都是：辦公室30平，庫房40平

四、辦理醫療器械三類，交件需要哪些材料？

1. 營業執照副本原件，公章

2. 法人、企業負責人、質量管理人身份證跟畢業證原件及復印件、職稱證明

3. 辦公室房產證、租賃合同復印件；

4. 庫房房產證、租賃合同復印件；（委托三方儲存的，需要三方物流資質復印件、庫房的產權證明和租賃合同復印件、物流服務協議和質量保證協議復印件；）

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、固定網絡等辦公設備）

3.門牌號、門牌logo

4.現場與平面圖一致；

5.不能有家居用品；

6.庫房要是空置狀態

7.擺放地拍或者貨架，溫濕度計，粘鼠板，滅火器，空調等

關于辦理醫療器械還有不清楚的，可以隨時聯系我，十余年經營專注于辦理醫療器械，北京各區政策十分了解，經驗十足，為您解決各種疑難問題?。?！

三類醫療器械經營許可證辦理流程及條件

國家對經營和銷售醫療器械的企業按照風險程度分為三類進行管理，這也就導致很多人認為醫療器械經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,