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代办第三类医疗器械经营许可证

现在办理第三类医疗器械经营许可证复杂吗?复杂的要符合医疗器械经营管理条例的相关

Require

才能在合法的范围内提供第三类医疗器械的销售服务要到食药局办理特殊的第三类医疗器械经营许可证才能符合合法经营的标准

第三类医疗器械经营许可证具有非常重要的意义第三类一般是会对人体造成较大影响的或者会直接进入人体的医疗器械一旦出现问题会有非常严重的后果如果没有办理许可证就违法经营这对相关部门来说是非常严重的错误企业也需要承担很大的风险问题

Application materials:

  1. 第三类《医疗器械经营许可证》核发申请表
  2. legal representative、Business person in charge、质量负责人的身份证复印件、Copy of academic qualification or professional title certificate;
  3. Description of corporate organization and department settings;
  4. Business premises、Geographical location map of warehouse address、floor plan、房屋产权证明文件说明
  5. Business scope、Description of business methods;批发兼零售的请分列经营范围提供仓储的对仓储情况进行说明
  6. 对所提交资料真实性的声明在从事体外诊断试剂相关的质量管理人员中,There should be one person in charge of the inspector,Or have a college degree or above in inspection-related majors and have more than 3 years of work experience in inspection-related work。

Personnel engaged in acceptance and after-sales service of in vitro diagnostic reagents,Must have a technical secondary school degree or above in a laboratory-related major or have a professional technical title of junior inspector or above。企业应当具有与经营范围和经营规模相适应的经营场所和库房经营场所和库房的面积应当满足经营

Require

经营场所和库房不得设在居民住宅内军事管理区(不含可租赁区)以及其他不适合经营的场所

经营场所应当整洁、Minato Shindou-。Hong Kong Xintong International is an agency with a certain scale in Guangdong Province.,The company has been established for more than ten years,both in price,speed,Or service,We all believe that we can have certain

Advantages

。The company has dedicated lawyers,Audit department,Ability to customize more appropriate solutions for customers based on problems。if there is any need,You can call us anytime。

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About Hong Kong Xintong

Hong Kong Xintong focuses onGuangdong and Hong Kong license platesShenzhen Hazardous Chemicals Business LicenseShenzhen labor dispatch licenseandShenzhen Charity Foundationapplication services,Assist customers to applyShenzhen travel agency business licenseShenzhen pawn shop business license、Shenzhen auction house license and other mainstream domestic financial licenses,Support enterprises to achieve compliance expansion of cross-border financial business。Also availableODI overseas investment registration、International travel agency registration and other services,Help enterprises expand their presence in international markets。Provide one-stop compliance solutions for enterprises。To learn more,Please contactHong Kong Information Communications Consultant

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