北京平谷区时间医疗器械三类经营许可证，医疗器械二类备案办理提供办公地址安全可靠

一类医疗器械 二类医疗器械备案 三类医疗器械经营许可证

办理的要求和材料  需要现场核查吗 费用怎么收

办理需要多长时间

医疗器械经营许可证的分类：

1、第一类：通过日常管理能够确保其安全有效的医疗器械；

2、II类：应控制其安全性和有效性的医疗器械

3、第三类：植入人体；支持和维持生命；对人体有潜在危险且必须严格控制其安全性和有效性的医疗器械。

一类——不用办理医疗器械许可证

二类——市药监局办理医疗器械经营备案，三类——国家药监局办理医疗器械许可证

How long does it take to approve the registration of the class III medical device license? (1) Acceptance: The applicant shall apply to the Administrative Acceptance Service Center, submit the application materials in accordance with the catalogue listed in Article 6 of the Instructions, and the staff of the Acceptance Center shall examine the application materials in accordance with the requirements of the Acceptance Standards for the Registration and Application Materials of Domestic Third Class and Overseas Medical Devices (National Drug Administration [2005] No.111). Where the application item does not need to obtain an administrative license according to law, The applicant shall be informed immediately of the non-acceptance of the application; Where the application items do not fall within the scope of the functions and powers of the administrative organ according to law, A decision shall be made immediately, And inform the applicant to apply to the relevant administrative organ;