怎么办理医疗器械经营许可证|要看场地吗（附详细流程）

怎么办理医疗器械经营许可证|要看场地吗（附详细流程）怎么办理医疗器械经营许可证|要看场地吗（附详细流程）申请《医疗器械经营企业许可证》的场地

Require

：办公室实用面积80平以上，仓库40平以上，commercial use，提供房产证复印件和租赁合同（或场地使用证明），有相应办公和仓库设施；申请《医疗器械经营企业许可证》的人员

Require

：法人1位（提供身份证和毕业证），企业负责人1位、质量负责人1位、专业技术人员3位、提供毕业证，ID card，体检报告，social security certificate；​申请《医疗器械经营企业许可证》的条件：1、Have a quality management organization or full-time quality management personnel that is suitable for the business scale and scope of business。

Quality management personnel should have relevant professional academic qualifications or professional titles recognized by the state；

1. Have a relatively independent business location that is commensurate with the business scale and scope of business；
2. Have storage conditions suitable for the business scale and business scope，Including products that comply with the characteristics of medical devices

Require

storage facilities、equipment；

1. A sound product quality management system should be established，including procurement、Incoming goods acceptance、Warehousing and storage、Warehouse review、Quality tracking system and adverse event reporting system, etc.；
2. Should have technical training and after-sales service capabilities suitable for the medical device products it operates.，Or agree to have a third party provide technical support。

申请《医疗器械经营企业许可证》时，应当提交如下资料：

1. "Medical Device Business Enterprise License Application Form"；
2. 工商行政管理部门出具的企业名称预核准证明文件；
3. ID card of the quality management personnel of the proposed enterprise、Copies of academic qualifications or professional title certificates and resume；
4. The organizational structure and functions of the proposed enterprise；
5. Proposed business registration address、Geographical location map of warehouse address、Floor plan (specify area)、房屋产权证明（或者租赁协议）复印件；
6. 拟办企业产品质量管理制度文件及储存设施、Device catalog；
7. 拟办企业经营范围。

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