深圳第三类医疗器械经营许可代理

Hong Kong Xintong Peng Yi Aaron thinks，第三类医疗器械经营许可个人办理很难，但是寻求代办机构就会简单很多！一百平左右的场地，几个有相关资质的人员，只要能准备好这两样，其余的我司都可以帮你解决。如果确实找不到合适的人员和场地，我们这边也有暂时的人员可以提供。

现在是疫情期间，大家都想从医疗器械经营中分一杯羹，有关部门确实也把条件定的高了。

one、Application conditions：

1. Have operations that are commensurate with the business scope and scale of the business、storage place；
2. Have quality management organizations or quality management personnel that are commensurate with the business scope and scale of operations，Quality management personnel should have relevant professional academic qualifications or professional titles recognized by the state；
3. Have a quality management system suitable for the medical devices it operates；
4. Have professional guidance appropriate to the medical devices being operated、Technical training and after-sales service capabilities，Or agree to provide technical support from relevant institutions。
5. Have storage conditions suitable for the business scope and scale，If all storage is entrusted to other medical device operating enterprises, there is no need to set up a warehouse.；two、Declaration procedure：受理—审查—现场勘查—发证。

three、Application materials：

1. Copies of business license and organization code certificate；
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. Basic introduction and function description of computer information management system；
9. Certificate of authorization of the person in charge；
10. Other supporting materials。

Four、Legal basis：

1. "Regulations on the Supervision and Administration of Medical Devices"；
2. 《医疗器械经营监督管理办法》（国家食品药品监督管理总局令第8号）。five、承诺时限：3个工作日（现场勘查时间不计算在内）。办理深圳第三类医疗器械经营许可应当注意的问题大致就是这些，希望想要申请的企业都能顺利取得资质！

During the application process，有任何疑惑或是难题，都可以直接致电我们，相信一定可以对您有所帮助。Related products：深圳第三类医疗器械经营许可代理

About Hong Kong Xintong

Hong Kong Xintong focuses onGuangdong and Hong Kong license plates、Shenzhen Hazardous Chemicals Business License、Shenzhen labor dispatch licenseandShenzhen Charity Foundationapplication services，Assist customers to applyShenzhen travel agency business license、Shenzhen pawn shop business license、Shenzhen auction house license and other mainstream domestic financial licenses，Support enterprises to achieve compliance expansion of cross-border financial business。Also availableODI overseas investment registration、International travel agency registration and other services，Help enterprises expand their presence in international markets。Provide one-stop compliance solutions for enterprises。To learn more，Please contactHong Kong Information Communications Consultant。