Port communication医疗器械经营许可办理须知 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。
address
Require
： 注册地址和实际经营地址必须一致 二类地址： 办公30平 仓库15平 （抽查） 普通三类地址： 办公30平 仓库15平（现场核查） 特殊三类地址：办公100平 仓库60平 人员
Require
： Category II
Require
质管员1名：medicine、护理专业、College degree or above。
Category three
Require
质管员、质检员各一名：medicine、护理专业、College degree or above。
Materials required：
- Original business license、复印件（分公司的话还需另提供总公司证件）
- official seal
- legal representative、Business person in charge、Proof of identity of the quality manager、Copy of academic qualification or professional title certificate；
- 组织机构示意图（重点质量管理部门）和部门设置职能和人员组成说明
- 产品分类目录编号、分类名称，及产品注册证复印件（加盖供应商公章）
- business address、Geographical location map of warehouse address
- Business premises、库房地址的内部平面布局图（注明使用面积）；
- Business premises、库房地址房屋产权证明文件或者租赁协议（附房屋产权证明文件）复印件，如为转租需提供产权人的相关同意转租文件；如为租赁协议即将到期需提供产权人同意续租证明等。
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。
