How much does it cost to register Class II medical devices in Shenzhen?

深圳二类医疗器械办理不贵，市场价格再三千五到五千，看是哪个区以及客户需要的时间来定的，注意提供的材料，我这里准备了详细的资料发不出来，有需要的企业主可以参考，每个区都是有点差异，但是大致相同，有不明白哦的随时电话联系。

二类医疗器械经营备案申请材料

Require

：

1. Class II medical device business registration form
2. Copies of business license and organization code certificate
3. legal representative、Business person in charge、质量负责人的身份㊣明、学历或者职称㊣明复印件
4. Organizational Structure and Department Setup Instructions
5. Business scope、Description of business methods;
6. Business premises、Geographical location map of warehouse address、floor plan、房屋产权㊣明文件或者由房屋租赁所出具的租赁凭㊣复印件;
7. Business facilities、Device catalog;
8. Operation quality management system、Work program and other file directories;
9. 经办人授权㊣明。

三类医疗器械经营备案注册地址有

Require

：

1. The office area is not less than 40 square meters；
2. The warehouse area is not less than 40 square meters;(Those containing in vitro diagnostic reagents require a refrigerated warehouse)
3. If disposable consumables are included

Require

The office address and warehouse area together cannot be less than 150 square meters Note：经营场所和仓库均不得设置在居民住宅内三类医疗器械经营备案人员有

Require

：1、A legal person who concurrently serves as the person in charge of an enterprise must have a college degree or above.，Not professional

Require

；2、The quality manager needs to have more than 3 years of work experience，College degree or above，相关专业毕业三类医疗器械经营仓库

Require

分类汇总：one、医疗器械设备类 《提供常温库》二、医疗器械植入介入类 《提供常温库》三、医疗器械耗材辅料类 《提供常温库》四、医疗器械体外诊断试剂类 《提供库房冷库》五、如您办理医疗器械没有地址、No competent inspector、没有医疗管理软件我们可以提供。

深圳港信通国际商务有限公司是一家专业的商务服务公司。公司开办以来为众多企业解决了问题。

医疗美容机构注册资质审批许可，口腔门诊注册资质审批许可，中医诊所备案医疗器械经营许可（从事一类的可直接在营业执照添加就可以销售、从事二类的应去当地的食药局办理二类医疗器械经营备案、从事三类的需要第一步上交材料材料通过以后等待专员上门核查核查通过以后就可以领取第三类医疗器械经营许可），如果您有以上需求本公司可以免费咨询港信通-，一次合作终身朋友。

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