三类医疗器械许可证申请条件

详细介绍申请材料

1. 《医疗器械经营许可证申请表》（原件1份）。
2. 《营业执照》（复印件）。
3. Organization code certificate (copy)
4. ID card of the legal representative of the enterprise (1 copy，(check the original)。
5. Business person in charge、ID card of quality management personnel、Education certificate or professional title certificate (1 copy，(check the original)；Quality management personnel’s resume (1 original copy)。
6. List of professional and technical personnel (1 original) and ID cards of professional and technical personnel、Education certificate、Professional title certificate (1 copy each)，(check the original)。
7. Business premises、Floor plan of the warehouse site and documents proving the property or use rights of the warehouse (1 copy)。It is a third-party logistics for medical devices entrusted by warehousing，Provide entrustment contract (1 copy，(check the original)。
8. Organizational Structure and Department Setup Instructions
9. Business scope、Description of business methods
10. Business facilities、Device catalog
11. 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 (1 original copy)。
12. Basic introduction and function description of the computer information management system installed by the enterprise，Print the home page of the information management system (1 original copy)。
13. When applying for enterprise declaration materials，The person handling the matter is not the legal representative or the person in charge of the enterprise himself，The enterprise should submit a "Power of Attorney" (1 original copy)。
14. Self-guarantee 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 (1 original copy)

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。