2025深圳二类医疗器械经营备案流程解析

2025深圳二类医疗器械经营备案流程解析办理所需资料有哪些医疗器械行业也是一个发展非常迅速的行业，在深圳就有很多从事医疗器械经营的企业。我们知道医疗器械行业是一个政府管控比较严格的一个行业。想要从事这个方面的业务一定要拿到相关的证书或者备案才行。

Medical devices are divided into categories、Category II、Category three、今天港信通给大家分享下二类医疗器械的备案流程和所需资料。

one、二类医疗器械备案的

Require

：

1. 具有法人主体资格，依法取得工商行政管理部门核发的工商营业执照或其他合法证明文件；
2. 商用性质地址用于办公80平，若是用于仓储则只需60平即可，Note：商住两用的房租性质不能使用；
3. 有三名大专以上医学相关专业毕业人员，并持有相关部门核发的、Professional title certificate；
4. 经营产品相关产品证书。

two、Medical device license scope：

1. Legal entities operating Class II and III medical device products、Unincorporated entities and branches established by legal entities shall apply for a "Medical Device Business Enterprise License"。Unless otherwise specified by the State Food and Drug Administration。
2. Financial leasing medical device products、A medical device operating enterprise or medical device manufacturing enterprise shall set up a business location to sell medical device products in a place other than the registered address stated in the enterprise's "Medical Device Operating Enterprise License" or "Medical Device Manufacturing Enterprise License"，and medical device manufacturers selling medical device products beyond the scope of their own products.，Should apply for a "Medical Device Business Enterprise License"。
3. Unincorporated units apply for a "Medical Device Business Enterprise License"，Only contact lenses and care solutions included in Category II medical device products or Category III medical device products。

Process the required information：

1. 《营业执照》（复印件）；
2. legal representative、Business person in charge、Proof of identity of the quality manager、Educational qualifications or professional title certificate；
3. 专业技术人员一览表及专业技术人员的身份证、Education certificate、Professional title certificate；
4. Organizational Structure and Department Setup Instructions；Business scope、Description of business methods；
5. Business premises、Geographical location map of warehouse address、floor plan、Housing property ownership certificate or a copy of the housing rental certificate issued by the housing rental agency。

It is a third-party logistics for medical devices entrusted by warehousing，Provide entrustment contract；

1. Operation quality management system、Directory of documents such as work procedures, including procurement、acceptance、Warehouse、out of warehouse、Quality tracking、User feedback、Adverse event monitoring and quality incident reporting system and other documents；
2. Basic introduction and function description of the computer information management system installed by the enterprise，Print the home page of the information management system。

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