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北京平谷区材料医疗器械三类经营许可证,医疗器械二类备案办理提供软件售后保障

北京三类医疗器械经营许可证如何办理?

在北京怎么申请办理三类医疗器械经营许可证?

医疗器械经营许可证是指在国家药品监督管理局颁发的一种证书,给予符合条件的医疗器械经营单位在法定范围内经营医疗器械的资格。如果您想经营医疗器械,那么您必须持有相应的许可证。下面我详细说一下北京医疗器械资质怎么办理这个问题。

一、《医疗器械经营许可证》怎么办理?

医疗器械企业办理的程序主要包括以下3个步骤:

1.申请营业执照

执照经营范围带第一类医疗器械销售:第二类医疗器械销售;第三类医疗器械经营。

2.准备资质许可证申请材料

医疗器械经营许可申请表;法定代表人、企业负责人、质量负责人的中华人民共和国居民身份证、学历或者职称证书;企业基本情况;企业设施设备情况;企业对所提供材料真实性的声明

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; 


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