Apply for a medical device license

For medical equipment license process, what information is required? for "medical device license business license" required materials:

1. an original business license, "Medical Device License Application Form"

2. a copy of the business license of the "business license";

3. a copy of the organization code certificate;

4. legal representative, the person in charge of the enterprise, the person in charge of the quality of the identity of the person in charge of the certificate, academic or professional title certificate Copy;

5. quality management personnel resume (an original);

6. list of professional and technical personnel (an original), professional and technical personnel ID card, certificate of education, title certificate each;

7. organizational structure and departmental setup instructions;

8. scope of business, the business mode of description;

9. business premises, warehouse address of the geographic location of the map, Floor plan, documents proving ownership of housing or housing rental company issued a copy of the lease certificate. Medical device warehousing entrusted to a third-party logistics, provide a copy of the commissioning contract;

10. Business facilities and equipment directory;

11. Business quality management system, work procedures and other documents directory, including procurement, acceptance, warehousing, storage, quality tracking, feedback from the user, monitoring of adverse events and quality incident reporting system.

12. for medical device license companies have installed computer information management system basic information and functional description, print the first page (the original one);

13. Where the application for the enterprise declaration materials, if not the legal representative or person in charge of himself, should be submitted to a "letter of authorization";

14. self-assurance of the authenticity of the declaration of materials, including the directory of application materials and enterprises such as providing false materials. And enterprises such as the provision of false material commitment (an original);

What materials are required for the medical device license?

Application ---- submit materials ---- registration submission ---- audit ---- complete the application

Applicants submit materials application form

1, "Medical Device Business License", "Medical Device Business License Application Form";

2, where the application for the enterprise declaration of materials, non-statutory representative or the person in charge of the person himself, should be submitted to the "letter of authorization

3, "Medical Device Business License" confirmation;

4, apply for a license report;

5, business premises / warehouse documents, property certificates or lease agreements and the lessor's copy of the property certificates;

6, the business premises / warehouse floor plan;

7, the quality of the managers in the post self-assurance statement and the authenticity of the application material self-assurance Statement, including the directory of application materials and business commitment to bear legal responsibility for any false;

8, the legal person in charge, the person in charge of the enterprise, quality management personnel, a copy of ID card, a copy of the certificate of academic qualifications or professional title certificate and resume;

9, a list of technical personnel and a copy of the academic certificate;

10, to obtain the industrial and commercial administration issued by the "License business license" or "pre-approval of enterprise name notification Or "pre-approval notice of enterprise name";

11, business quality management standardized document catalog;

12, the enterprise has installed the product procurement, sales, storage information management system, printed on the first page of the information management system;

13, warehouse equipment catalog;