找到了！申请三类医疗器械公司的难点在

找到了！申请三类医疗器械公司的难点在 找到了！申请三类医疗器械公司的难点在 不知道你有没有发现一个事实，就是现在的人们寿命总是比古代的人更加的长，究其原因只有一个，那就是现在的医疗水平远远超过过去，from childhood to adulthood，各种预防，科学的研究也是其中不可或缺的一部分。

第三类医疗器械许可证办理所需条件：

1. Apply for a medical device business license，首先要有地址，三类医疗器械又分为三小类。每个类别的地址面积

Require

All different。但是租个160平的地址准没错。

1. 地址搞定，就是人员啦，人员至少3名，

Require

是医疗相关行业毕业的。

1. 最后一点，像医疗器械这类型的必须要有产品证书。

第三类医疗器械许可证办理所需材料：

1. "Medical Device Business Enterprise License Application Form"。
2. 《企业名称预先核准通知书》或《工商营业执照》。
3. Business premises、Documentation proving the warehouse location，Include a copy of the property certificate or lease agreement and the lessor’s property certificate。
4. Business premises、Warehouse layout plan。
5. Person in charge of formulating the law、Business person in charge、Quality manager’s ID card、Copy of academic certificate or professional title certificate and resume。
6. Technical personnel search list and academic qualifications、Copy of professional title certificate。
7. Business quality management specification document directory。
8. Enterprise installed product purchases、pin、stored information management system，Print the home page of the information management system。
9. Warehousing Facility Equipment Catalog。
10. Quality management personnel’s on-the-job self-assurance statement and self-assurance statement on the authenticity of application materials，Including the catalog of application materials and the company's commitment to bear legal responsibility if the materials are false.。

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