2025深圳如何办理三类医疗器械许可证_办理材料

2025深圳如何办理三类医疗器械许可证_办理材料 2025深圳如何办理三类医疗器械许可证_办理材料 医疗器械经营许可证是医疗器械经营企业必须具备的证件，Establishing a second-category medical device operating enterprise，必须取得备案；Establishing a third-category medical device operating enterprise，必须取得医疗器械经营许可证。

一类医疗器械不需要备案或者审批，直接在执照经营范围上添加即可。（以上均指销售医疗器械的） 审批部门：深圳各区食品药品监督管理局 有效期：二类备案 长期有效 ；三类许可证 5年有效期 审批时间：25个工作日 医疗器械属于 后置审批，先办公司，再办理备案或者审批。

深圳三类医疗器械许可

Application conditions

：

1. The usable area of ​​the business premises should be no less than 40 square meters，法人单位分支机构的经营场所使用面积应当不小于25平方(Except for those set up across districts and cities);Dealer of hearing aids，The usable area of ​​the business premises should not be less than 25 square meters;经营隐形眼镜及护的，经营场所使用面积应当不小于平方米。
2. The usable area of ​​the warehouse should be no less than 30 square meters;Dealing in disposable sterile medical equipment，The warehouse should be in the same building，面积 应当不小于200平方米。
3. quality manager、The person in charge of the quality organization should have a nationally recognized、Majors related to product management，College degree or above or intermediate technical title or above in related majors。

Dealing in disposable sterile medical equipment,There should also be more than one internal auditor holding a medical device quality management system internal auditor certificate and other relevant

Application conditions

。

深圳三类医疗器械许可证申请所需材料：

1. Company name and business scope，Registered capital and shareholder capital contribution ratio，股东等身份正明；
2. Medical device product registration certificate、Supplier business license、Licenses and Authorizations；
3. Quality management documents, etc.；
4. 2Certificates for one or more medical majors or related professionals、身份正明与简历；
5. Comply with medical device business

Require

的办公场地及仓库正明；

1. Articles of Association、Shareholders' meeting resolutions, etc.；
2. 财务人员身份证与上岗证；
3. Other related materials； 深圳三类医疗器械许可证

Application process

：

1. Applicants submit application materials to relevant departments；
2. Relevant departments accept applicants’ applications；
3. Go to the actual site to conduct surveys and review products；
4. Approved to issue Class III medical device license；
5. Issuance of Class III medical device license。

以上是深圳如何办理三类医疗器械许可证详细介绍，可关注留言哦 搜索“马德仪”“申与城”

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