2025Operation Guide for Medical Device Business License Application

2025Operation Guide for Medical Device Business License Application Materials for Medical Device Business License：

1. 　　
2. Fill out the "Medical Device Business Enterprise License" application form in triplicate (copies are invalid)； 　　
3. 1 application report；Find Xixing Investment Processing
4. Enterprise self-examination summary (compare with the "Shanghai Municipal Medical Device Business Enterprise Qualification Accreditation Implementation Rules" and "Shanghai Municipal Audit、Replacement and Acceptance Standards》

Require

) 1 serving；

1. 　　
2. One copy each of the articles of association of the enterprise (company) and the latest capital verification report (the balance sheet and profit and loss statement of the enterprise for certificate renewal)；
3. business、Warehouse property ownership certificate or lease agreement and 1 copy of floor plan； 　　
4. technology、List of maintenance personnel and their diplomas、One copy of each professional title certificate (stamped with the official seal of the unit)；
5. 1 detailed written preliminary acceptance report from the Municipal Drug Administration； 　　
6. Various management rules and regulations。
7. Quality responsibility and veto system，
8. Warehouse acceptance、Storage and warehouse review system，(3)Quality analysis and feedback system，(4)Validity period management system，(5)Store sales quality management system，(6)special、Imported medical device management system，(7)Service (Installation、Use technology training、maintainance、Maintenance, etc.) system，(8)Implantation and special medical device quality tracking and adverse reaction reporting system，(9)return the goods、Unqualified、Expiration date or obsolete medical device disposal reporting system，⑽Health management system； 　　
9. 1 copy of the business name industrial and commercial pre-registration certificate or a copy of the "Legal Person Business License"； 　　
10. Statement of self-assurance regarding the authenticity of the information provided。

three、Declaration information

Require

1. 　　
2. All agents of Xixing Investment；The application report content should include：economic nature of enterprise、Brief introduction of the main person in charge、Department settings、Branch settings、Main business areas and main sales targets、Main business varieties、Specification、Warehousing place and surrounding environment
3. business、Warehouse floor plan：business、The storage location must indicate the length of、Width (meters)、Business layout and shelf placement，Fire equipment location、Five defense facilities, etc.。
4. technology、Maintenance personnel list：It specifically refers to science and engineering、medicine、Pharmacy、Engineering technicians，

Require

list names、gender、age、Later graduating school、Educational qualifications、major、Technical title、Company position、ID number。

1. All application materials must be printed on A4 paper，And stamp the company、Official seal of the unit or superior supervisory unit，Enterprise name industrial and commercial pre-registration certificate or copy of legal person business license、Technical and Maintenance Personnel Diploma、Copies of professional title certificates, etc.，The reporting unit should indicate on the copy”The copy matches the original”words and stamped with the official seal，Binned in order。

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