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深圳三类医疗器械经营许可证代办

港信通国际九年专注于广东省深圳和广州等地区内医疗器械许可正代理申请包含二类医疗器械三类医疗器械许可证申请、Add items、变更以及注销业务,Rich window service experience、熟悉各项工商

Process

从咨询、Additional conditions、备齐材料到审核发放资质港信通国际始终秉承一站式服务理念港信通国际成熟的办理模式是服务行业价格

Advantages

key,Welcome further communication。

深圳三类医疗器械经营许可证代办的条件

  1. The usable area of ​​the business premises should be no less than 40 square meters,The usable area of ​​the business premises of a branch of a legal entity shall be no less than 25 square meters.(Except for those set up across districts and cities);Dealer of hearing aids,The usable area of ​​the business premises should not be less than 25 square meters;Those who deal in contact lenses and care solutions,The usable area of ​​the business premises should not be less than 10 square meters。
  2. The usable area of ​​the warehouse should be no less than 30 square meters;Dealing in disposable sterile medical equipment,The warehouse should be in the same building,The usable area should be no less than 200 square meters。
  3. quality manager、The person in charge of the quality organization should have a nationally recognized、Majors related to product management,College degree or above or intermediate technical title or above in related majors。

Dealing in disposable sterile medical equipment,还应当有一名以上持有医疗器械质量管理体系内审员正书的内审员等其他相关

Application conditions

  企业主如果担心:The materials submitted for approval are not up to standard! The business address is not up to standard! There is no warehouse! The warehouse is unqualified! Worry without a professional quality manager!

请致电我们港信通国际商务有限公司:A professional team will assist you throughout the entire process,Let your business be put into operation as soon as possible,Relieve your worries and worries!

港信通协助代理

Application process

time flow:签订服务合同→准备申请资料→提交政府主管单位审核→通过初审→预约专管官员现场审查→审查通过进行复审→复审通过取正书医疗器械二类、Application time for three categories respectively:Class II medical device registration can be completed within one day after receiving the information.。The application for Class III medical devices can be completed within 40 working days after receiving the information.。

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