2025Registered medical device company transfers with Class III medical device license

《医疗器械经营企业许可证流程》准备资料—Submit application—-All materials submitted—-Registration submission—-Approved—-Below is the certificate "Transfer Target Situation of Medical Device Company" Name of transfer target of medical device company：Shenzhen XX Medical Equipment Co., Ltd. Medical equipment company transfer target business scope：”General business items： Category 1 medical device wholesale；Domestic trade (excluding franchised、monopoly、Exclusively controlled products)；Operating import and export business (legal、Administrative regulations、Except for items prohibited by the State Council’s decision，Restricted projects must obtain permission before they can be operated)。

Licensed business projects： The following projects involve matters that require licensing approval:，Relevant approval documents are required to operate:Category III medical device business。 “The registration time for medical device companies is in 2025 "Materials required for medical device operating enterprise license application"

1. "Medical Device Business Enterprise License Application Form"，"Medical Device Business Enterprise License"。
2. "Notice of Pre-approval of Enterprise Name" or "Industrial and Commercial Business License" issued by the industrial and commercial administration department。
3. Application report。
4. Business premises、Documentation proving the warehouse location，Include a copy of the property certificate or lease agreement and the lessor’s property certificate。
5. Business premises、Warehouse layout plan。
6. Person in charge of formulating the law、Business person in charge、Quality manager’s ID card、Copy of academic certificate or professional title certificate and resume。
7. List and academic qualifications of technical personnel、Copy of professional title certificate。
8. Business quality management specification document directory。
9. Enterprise installed product purchases、pin、stored information management system，Print the home page of the information management system。
10. Warehousing Facility Equipment Catalog。
11. Quality management personnel’s on-the-job self-assurance statement and self-assurance statement on the authenticity of application materials，Including the catalog of application materials and the company's commitment to bear legal responsibility if the materials are false.；
12. When applying for enterprise declaration materials，The person handling the matter is not the legal representative or person in charge himself，The enterprise should submit a "Power of Attorney"。
13. 申请《医疗器械经营企业许可证》确认书《医疗器械相关新闻》医疗器械进入数字化布局 差异化竞争成焦点数字化医疗的概念又一次烧到了医疗器械领域。 4Month 11th-14th，The 79th China International Medical Equipment (Spring) Expo (CMEF) was held in Shanghai，今年的主题为“医疗数字化时代 ·智慧医疗”。

Driven by the development of the global digital economy and industry needs，All links in the high-barrier industrial chain of medical care are also undergoing digital transformation and impact.。

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。