北京房山中盛启诚医疗器械专业代理》医疗器械二，三类经营许可证，医疗器械网络销售备案》专业快捷方便

开办第三类医疗器械经营企业，应当经省、自治区、直辖市人民政府药品监督管理部门审查批准，并发给《医疗器械经营许可证》。

依据《医疗器械经营监督管理办法》，开设三类医疗器械运营公司，食品类药品监督管理局单位将会对经营地开展当场审查。对不符合要求标准的，明确提出整顿规定或未予批准。根据《药品医疗器械飞行检查办法》，食品类药品监督管理局单位将会对医疗机械销货方式合理合法、工作人员在职人员在职、拿货检查、运送储存等层面开展不事先告之的监督管理。三类医疗器械的界定

依据《医疗器械监督管理条例》，第三类医疗器械是具备较高危，必须采用非常对策严控管理方法以确保其安全性、合理的医疗机械。例如普遍的注射器、注射针、静脉留置针、心脏支架、麻醉机、CT、磁共振等。

怎样办理许可证？

01.

1、一类——不用办理医疗器械许可证 类医疗器械是风险程度低、实行常规管理可以保证其安全有效的医疗器械

，比如手术刀、手术剪、手动病床、医用冰袋、降温贴等，其产品和生产活动由所在地设区的市级食品药品监管部门实行备案管理。经营活动则全部放开，既不用许可也不用备案，只需取得工商部门核发的营业执照即可。

02.

二类——市药监局办理医疗器械经营备案第二类医疗器械是具有中度风险，需要严格控制管理以保证其安全有效的医疗器械，比如我们日常生活中常见的创可贴、避孕套、体温计、血压计、制氧机、雾化器等，其产品和生产活动由省级食品药品监管部门实行许可管理，分别发给《医疗器械注册证》和《医疗器械生产许可证》。经营活动由设区的市级食品药品监管部门实行备案管理;

03.

三类——国家药监局办理医疗器械许可证第三类医疗器械是具有较高风险，需要采取特别措施严格控制管理以保证其安全有效的医疗器械，比如常见的输液器、注射器、静脉留置针、心脏支架、呼吸机、CT、核磁共振等，其产品和生产经营活动分别由国家zongju、省级食品药品监管部门和设区的市食品药品监管部门实行许可管理，分别发给《医疗器械注册证》、《医疗器械生产许可证》、《医疗器械经营许可证》。

办理医疗器械三类经营许可证需要哪些材料？

1.法定代表人、企业负责人、质量负责人、售后服务人员等人员的身份证明、学历或者职称证明原件照片或复印件

2.组织机构与部门设置说明

3.经营范围、经营方式说明

4.经营场所、库房地址的地理位置图、平面图、房屋产权证明文件或者租赁协议（附房屋产权证明文件）复印件

5.经营设备、设备目录

6.经营质量管理制度、工作程序等文件目录

7.计算机信息管理系统基本情况介绍和功能说明

8.经办人授权证明

9.材料真实性声明

办理医疗器械三类经营许可证的流程是什么？

1. 提交申请

2. 窗口受理

3. 审核材料

4. 老师下户现场检查

5. 审批通过

6. 领取医疗器械三许可证

申请三类医疗器械经营许可证需要满足相关的资质要求和管理要求，申请过程比较复杂，建议企业在申请前了解相关政策法规，以及咨询的医疗器械代办公司或律师事务所，提高申请成功率

To establish a third category medical device operatingenterprise, it shall be reviewed and approved by the drugregulatory department of the provincial, autonomous region, ormunicipality directly under the Central Government, and issued aMedical Device Operating License.

How to apply for a license?

one

1. Class I - Medical Device License Not Required. Class Imedical devices are those with low risk and can be ensured to besafe and effective through routine management

For example, surgical knives, surgical scissors, manual hospitalbeds, medical ice packs, cooling patches, etc., their products andproduction activities are subject to record management by the foodand drug regulatory department at the city level where they arelocated. All business activities will be fully opened up, withoutthe need for permits or filing. Only the business license issued bythe industry and commerce department is required.

two

Class II - Medical Device Operation Filing by the MunicipalMedical Products Administration. Class II medical devices havemoderate risks and require strict control and management to ensuretheir safety and effectiveness. For example, commonly seen in ourdaily lives, such as band aids, condoms, thermometers, bloodpressure monitors, oxygen concentrators, nebulizers, etc., theirproducts and production activities are subject to licensingmanagement by provincial food and drug regulatory departments,which issue "Medical Device Registration Certificate" and "MedicalDevice Production License" respectively. Business activities aresubject to record management by the food and drug regulatorydepartments at the city level with districts;

three

Three categories - National Medical Products Administrationapplies for medical device license. The third category of medicaldevices has high risks and requires special measures to strictlycontrol and manage them to ensure their safety and effectiveness,such as common infusion sets, syringes, intravenous catheters,heart stents, ventilators, CT scanners, magnetic resonance imaging,etc. Their products and production and operation activities aresubject to licensing management by the General Administration ofChina, provincial food and drug regulatory departments, anddistrict level city food and drug regulatory departments, and areissued with "Medical Device Registration Certificate", "MedicalDevice Production License", and "Medical Device Business License"respectively.

What materials are required to apply for a Class III businesslicense for medical devices?

1. Original photos or copies of identity certificates,educational background or professional title certificates of legalrepresentatives, enterprise leaders, quality managers, after-salesservice personnel, etc

2. Explanation of Organizational Structure and DepartmentSettings

3. Business scope and mode of operation description

4. Copy of geographical location map, floor plan, propertyownership certificate or lease agreement (with property ownershipcertificate attached) of the business premises and warehouseaddress

5. Operating equipment and equipment catalog

6. Catalog of documents such as management quality system andwork procedures

7. Introduction and Function Description of Computer InformationManagement System

8. Authorization Certificate of the Agent

9. Material Authenticity Statement

What is the process for obtaining a Class III business licensefor medical devices?

1. Submit an application

2. Window acceptance

3. Review materials

4. Teacher's on-site inspection upon arrival

5. Approval passed

6. Obtain the three licenses for medical devices