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北京平谷区流程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服务周到

发布时间: 2023-10-19 13:57 更新时间: 2024-12-01 07:09



4. 申请递交:将准备好的申请材料递交给北京市食品药品监督管理局或相应的区县级药监部门。

 

5. 审核及评审:申请材料递交后,相关部门会进行审核和评审,包括对质量管理体系的合规性、产品技术的合规性、生产场所的合规性等方面的审查。

 

报告批准:如果申请符合相关要求,审核通过后,相关部门会向申请人颁发三类医疗器械许可证。

1. What is a medical device? Beijing wants to understand the enterprises to see here Medical device: refers to instruments, equipment, appliances, materials or other articles used individually or in combination, including required software; their function on the surface of the body is not obtained by pharmacological, immunology or metabolic means, but may participate and play a certain auxiliary role. 2. How many categories are medical devices divided into? There are three categories: The operation of the first type of medical devices does 


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