深圳二类医疗器械备案难办吗

注册深圳公司二类医疗器械备案需要哪些资料？深圳市办理二类医疗器械备案需要什么条件和资料?深圳二类医疗器械备案怎么办理？一定要准备商用房产证或者场地使用证明才可以办理二类医疗器械经营备案吗？想必这些都是大家想要了解的问题。

眼下深圳市医疗器械发达，二类医疗器械新兴发展，尤其是现在京东及淘宝客户加盟和审核需要，都需要办理二类医疗器械经营备案！

one、For Class II medical device business registration registration address:

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

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（很多电商朋友达不到这个

Require

，没有关系，现在地址也是可以**的）二、For Class II medical device business registration personnel, there are

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，Graduated from related majors；Medical device related majors：medical device、biomedical engineering、mechanical、electronic、medicine、Bioengineering、Chemical、Nursing、recovery、Laboratory Science、manage、Computer and other majors 3、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、Proof of identity of the 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. Certificate of authorization of the person in charge；
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）；11、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)。

Related products：Class II medical devices

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