How long does it take to apply for a Class II medical device license?

Materials required for Category II application filing：

1. Class II medical device business registration form；
2. Copies of business license and organization code certificate；
3. Identity and academic qualification certificate of the legal representative or person in charge of the enterprise；
4. Description of corporate organization and department settings；
5. Business scope、Method description；
6. Business premises、Warehouse address rental voucher、House property ownership documents；
7. Business premises、Facilities at warehouse address、is cataloged；
8. Certificate of authorization of the person in charge；How long does it take to apply for a Class II medical device license?
9. Commitment materials for the authenticity of application materials，Signature and seal of legal person；
10. Other supporting materials。

监督检查的主要内容包括：

1. Company name、企业法定代表人或者负责人及质量管理人员变动情况。
2. 企业注册地址及仓库地址变动情况。
3. business place、存储条件及主要储存设施、设备情况。
4. 经营范围等重要事项的执行和变动情况。
5. 企业产品质量管理制度的执行情况。
6. 其他需要检查的有关事项。
7. 二类医疗器械许可证代办时间多长五、补证:How long does it take to apply for a Class II medical device license?
8. A copy of the loss statement (public media) (proofread original)；
9. A letter of authorization (with a copy of the handling person’s ID card)；
10. An application form for renewal of certificate；
11. One copy of the original "Business License" (proofread original)。

six、Log out：How long does it take to apply for a Class II medical device license?

1. A letter of authorization (with a copy of the person’s ID card attached)；
2. Cancellation application form in triplicate；
3. "Medical Device Business Enterprise License"、copy。The content of this article is strictly prohibited from being reproduced by any website or individual.，Violators will be prosecuted。Related products：Medical device transfer , Medical device registration , Apply for medical devices

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