Do you know what materials are needed to register a medical device company in Shenzhen?

你知道在深圳注册医疗器械公司需要什么材料吗？ 作为远东地区第一大城市——深圳。老龄化问题尤为严重，越来越多的老年人注重对身体健康的投资，所以在深圳医疗器械市场格外繁荣，也给了许许多多从事医疗器械行业的小伙伴们更多创业的机会。 怎样办理医疗器械许可证一类,Category II,Category three,What's there

Require

Woolen cloth?

one、二类医疗器械经营备案有

Require

：

1. The office area is not less than 50 square meters；
2. The warehouse area is not less than 50 square meters；(Those containing in vitro diagnostic reagents require a refrigerated warehouse)
3. If disposable consumables are included

Require

办公地址和仓库面积一起不能低于150平方 注：经营场所和仓库均不得置在居民住宅内 二、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

；

1. The quality manager needs to have more than 3 years of work experience，College degree or above，Graduated from related majors； Medical device related majors：medical device、biomedical engineering、mechanical、electronic、medicine、Bioengineering、Chemical、Nursing、recovery、Laboratory Science、manage、计算机等专业 三、For the second type of medical device business registration materials, there are

Require

：

1. Class II medical device business registration application form
2. Copies of business license and organization code certificate；
3. legal representative、Business person in charge、Identity of quality manager、Copy of academic qualification or professional title certificate；
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、Copy of property ownership certificate or lease agreement (with property ownership certificate attached)；
7. Business facilities、Device catalog；
8. Operation quality management system、Work program and other file directories；
9. 授权证明；
10. 计算机信息管理系统基本情况介绍和功能说明（鼓励第二类医疗器械经营企业建立符合医疗器械经营质量管理

Require

computer information management system，如无此项，可免说明）；

1. Other supporting materials (such as operating in vitro diagnostic reagents，According to the business standards for applying for in vitro diagnostic reagents

Require

Provide additional materials such as medical laboratory personnel and cold chain facilities and equipment)

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