2025深圳第二类医疗器械经营备案凭证要什么流程

深圳二类医疗器械经营备案是法律依据医疗器械监督管理条例第三十条，相关条件从事医疗器械经营活动，应当有与经营规模和经营范围相适应的经营场所和贮存条件，以及与经营的医疗器械相适应的质量管理制度和质量管理机构或者人员。

二类医疗器械经营备案申请材料

Require

：

1. 　　
2. 第二类医疗器械经营备案表　　
3. 营业执照和组织机构代码证复印件　　
4. legal representative、Business person in charge、Proof of identity of the quality manager、学历或者职称证明复印件　　
5. 组织机构与部门设置说明　　
6. Business scope、Description of business methods;　　
7. Business premises、Geographical location map of warehouse address、floor plan、Property ownership certificate or a copy of the lease certificate issued by the house leasing agency;　　
8. Business facilities、Device catalog;　　
9. Operation quality management system、Work program and other file directories;　　
10. Certificate of authorization of the person in charge。

Process

图

1. 　　
2. 现场递交材料;　　
3. 确认受理(conform to

Require

的受理，Does not meet

Require

的退回);

1. 　　
2. Approval;　　
3. 办结打证　　办理医疗器械经营许可证需要按照经营的医疗器械产品属于几类来区分，经营类医疗器械不需许可和备案，The operation of Class II medical devices shall be subject to registration management，License management is implemented for operating Class III medical devices。

可靠的确定产品分类的方式就是问厂家。

Those engaged in the business of Class II medical devices，经营企业应当向所在地设区的市级食品药监督管理部门备案，Fill out the Class II Medical Device Business Registration Form，and submit the following information：

1. 　　
2. Copies of business license and organization code certificate；（如果公司还未注册就先走公司

Registration process

，办好公司营业执照后再办二类医疗器械经营备案）

1. 　　
2. legal representative、Business person in charge、Proof of identity of the quality manager、Copy of academic qualification or professional title certificate；　　
3. Organizational Structure and Department Setup Instructions；　　
4. Business scope、Description of business methods；　　
5. Business premises、Geographical location map of warehouse address、floor plan、Copy of property ownership certificate or lease agreement (with property ownership certificate attached)；　　
6. Business facilities、Device catalog；　　
7. Operation quality management system、Work program and other file directories；　　
8. Certificate of authorization of the person in charge；　　
9. Other supporting materials。

现在在淘宝、Tmall、京东等电商平台开店销售二类医疗器械，要先办理二类医疗器械经营备案凭证，然后进行网络销售备案。医疗器械第二类经营备案凭证和医疗器械经营企业许可证有什么不同?　　经营一类、Class II medical devices require medical device registration certificate，经营三类的医疗器械需要经营生产许可证。

Production license：生产许可证有效期为4年，期满前6个月内，须持原证重新申请，生产许可证实行年检制度。生产许可证包括许可证编号、Company name、legal representative、Business person in charge、Business type、Registered address、生产地址、生产范围、issuing authority、发证日期、有效期限等项目。

Class II medical devices：二类医疗器械是指，to its security、Medical devices whose effectiveness should be controlled。X线拍片机、B-ultrasound、microscope、生化仪属于Ⅱ类。Business Category II、第三类医疗器械应当持有《医疗器械经营企业许可证》。需要代办找林经理直接渠道加急审批，当天能批下来。价格美丽。Related products：2025深圳第二类医疗器械经营备案凭证要什么流程

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