二类医疗器械备案申请

Hong Kong Xintong Peng Yishuo Resources：With the development of society，Major companies have emerged one after another，而一个企业如果没有资质是一定无法在市场上立足的。有了资质，It is equivalent to having certification，是企业运行的必要证明文件。

For Class II medical device business registration registration address:

Require

2113：

1. 　　
2. The office area is not less than 40 square meters;　　
3. 仓库面积不少于15平方;如果仓储委托第三方物流公司，需要有医疗器械许可资质的物流公司即可。

For Class II medical device business registration personnel, there are

Require

：

1. 　　
2. 具有医疗器械、medicine、药学专业大学本科以上或中级以上技术职称人员1名，作为质量负责人　　
3. 具有高中以上学历2名，作为质量管理员;医疗器械经营备案凭证所需要1653的申请材料：
4. Class II medical device business registration form
5. Copies of business license and organization code certificate
6. legal representative、Business person in charge、质量负责人的身份证明版、Copy of academic qualification or professional title certificate
7. Organizational Structure and Department Setup Instructions
8. Business scope、Description of business methods;
9. Business premises、Geographical location map of warehouse address、floor plan、Property ownership certificate or a copy of the lease certificate issued by the house leasing agency;
10. Business facilities、Device catalog;在办理资质的时候会遇到各种各样的麻烦，In order to solve this problem，资质代办公司营运而生，Hong Kong Xintong International is one of them。

如果有需要要做二类医疗器械备案申请，You can contact me directly。Related products：二类医疗器械备案申请

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