深圳经营哪些医疗器械需要办理许可证？

深圳经营哪些医疗器械需要办理许可证？一、什么是经营性医疗器械许可证？

A medical device business license is a must-have document for medical device operating companies.，Establishing a second-category medical device operating enterprise，should report to the province、autonomous region、Registration with the Drug Supervision and Administration Department of the People's Government of the Municipality directly under the Central Government；Establishing a third-category medical device operating enterprise，Should reflect on、autonomous region、Review and approval by the drug regulatory department of the municipal people’s government，And issued a "Medical Device Business Enterprise License"。

Medical device business license is now post-approval，The industrial and commercial administration department shall apply for approval after issuing a business license.。The "Medical Device Business Enterprise License" is valid for 5 years。

Medical devices are divided into three categories：A category、Category II、Category three，Currently, operating a category of products does not require a medical device business license.，Operating Category II products requires a Category II medical device business registration certificate，Only those who operate three types of products need to apply for a medical device business license.，So what materials do medical device operating companies need to submit when applying for Class II medical device business registration and Class III medical device business licenses??two、第二类医疗器械第二类医疗器械是具有中度风险，Medical devices that require strict control and management to ensure their safety and effectiveness，For example, the common band-aids in our daily life、thermometer、sphygmomanometer、oxygen concentrator、Atomizer, etc.，Its products and production activities are licensed and managed by provincial food and drug regulatory authorities.，Issue "Medical Device Registration Certificate" and "Medical Device Production License" respectively。

Business activities are subject to registration management by the districted municipal food and drug regulatory authorities.;提交二类经营备案需要满足以下资料：

1. business license；
2. legal representative、Business person in charge、Proof of identity of the quality manager、Educational qualifications or professional title certificate；
3. Organizational Structure and Department Setup Instructions；
4. Business scope、Description of business methods；
5. Business premises、Geographical location map of warehouse address、floor plan、House property rights certificate or lease agreement (with house property rights certificate attached)；–必须是商业用地，有红本的租赁凭证，
6. Business facilities、Device catalog；
7. Operation quality management system、工作程序制度等文件；
8. Basic introduction and function description of computer information management system；（可以不用提供）
9. Certificate of authorization of the person in charge；
10. Other supporting materials。

three、第三类医疗器械第三类医疗器械是具有较高风险，Medical devices that require special measures to be strictly controlled and managed to ensure their safety and effectiveness，For example, a common infusion set、syringe、intravenous indwelling needle、heart stent、Ventilator、CT、NMR, etc.，Its products and production and operation activities are separately controlled by the State Administration of、Provincial food and drug regulatory authorities and districted city food and drug regulatory authorities implement licensing management，Issue "Medical Device Registration Certificate" separately、"Medical Device Production License"、"Medical Device Business License"。

提交三类经营备案需要满足以下资料：

1. 第三类《医疗器械经营许可证》核发申请表（一式贰份，不得手工填写）。
2. Copy of business license、组织机构代码证副本复印件（核对原件）；分支机构还需要提供总公司营业执照副本和第三类《医疗器械经营许可证》复印件（核对原件）分支机构的企业名称请事先征得营业执照管理部门认可。
3. legal representative、Business person in charge、质量负责人（或质量管理人员）的身份证复印件（正反面复印）、学历或者职称证明复印件（核对原件）。
4. Description of corporate organization and department settings。
5. Business scope、经营方式说明（明确品种、销售对象、经营模式;经营方式对照《医疗器械经营监督管理办法》第六十二条解释进行确定;批发兼零售的，请分列经营范围；提供仓储的，对仓储情况进行说明,仓储信息化建设情况可以参照《医疗器械经营质量管理规范》第三十一条作简要概述）。

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