北京昌平中盛启诚医疗器械专业代理》医疗器械二，三类经营许可证》售前有沟通，售后有保障，事事有回应，专业快捷方便

国家对经营和销售医疗器械的企业按照风险程度分为三类进行管理，这也就导致很多人认为医疗器械经营许可证也分为三类.

在北京如何办理三类医疗经营许可证，办理许可证又有哪些条件及流程，小编带着满满的干货知识与您分享。

什么叫做医疗器械?医疗器械是指直接或者间接用于人体的仪器、设备、器具、体外诊断试剂及校准物、材料以及其他类似或者相关的物品，包括所需要的计算机软件。而医疗器械经营许可证是三类医疗器械经营企业必须具备的证件。

国家对医疗器械按照风险程度实行分类管理。

经营一类医疗器械不需许可和备案，执照上面加上销售医疗器械一类就可以正常销售；

经营二类医疗器械需要办理备案；

经营三类医疗器械需要办理经营许可证。

办理二类备案您需要提供：

1.法人身份信息；

2.质量员身份信息；

3.公司营业执照正副本以及公章；

4.库房地址材料；

窗口交件后当天拿二类备案。

三类医疗器知械许可证注册所需材料

1、医疗器械产品注册证书、供应商营业执照、许可证及授权书;

2、质量管理文件等;

3、2个或以上医学專业或相关專业人员证书、身份证明与简历;

4、符合医疗器械经营要求的办公场地及仓库证明;

5、其它相道关材料。

窗口交件后5个工作日核查，核查通过后下证。

关于在京办理三类医疗器械经营许可证的更多问题，欢迎私信小编，

The state classifies enterprises engaged in the operation and saleof medical devices into three categories for management based onthe degree of risk, which has led many people to believe thatmedical device operating licenses are also classified into threecategories

How to apply for three types of medical business licenses inBeijing, and what are the conditions and procedures for obtaininglicenses? With a wealth of practical knowledge, I will share withyou.

Firstly, what is a medical device? Medical devices refer toinstruments, equipment, tools, in vitro diagnostic reagents andcalibrators, materials, and other similar or related items directlyor indirectly used for the human body, including the requiredcomputer software. The medical device operating license is anecessary document for three types of medical device operatingenterprises.

The state implements classified management of medical devicesaccording to their level of risk.

Operating a type of medical device does not require a license orfiling, and adding the category of selling medical devices to thelicense allows for normal sales;

Registration is required for the operation of Class II medicaldevices;

Operating three types of medical devices requires obtaining abusiness license.

To apply for Class II filing, you need to provide:

1. Corporate identity information;

2. Identity information of the quality officer;

3. Original and duplicate copies of the company's business licenseand official seal;

4. Warehouse address materials;

After submitting the documents at the window, register them asClass II on the same day.

Materials required for registration of Class III medical devicelicense

1. Medical device product registration certificate, supplierbusiness license, permit, and authorization letter;

2. Quality management documents, etc;

3. Two or more medical or related professional certificates,identification documents, and resumes;

4. Proof of office space and warehouse that meet the requirementsfor medical device operation;

5. Other related materials.

After submitting the documents at the window, it will be verifiedwithin 5 working days. Once the verification is passed, thecertificate will be issued.

For more questions about obtaining the business license for threetypes of medical devices in Beijing, please feel free to send aprivate message to the editor,