1. new quality person in charge of the valid proof of identity, academic qualifications, title and health certificate, work resume, proof of departure, appointment documents and employment agreement ((business with implantable interventions need to be equipped with the scope of)). College degree or above in medicine-related professions, and after the production company or supplier training of qualified personnel; operation of in vitro diagnostic reagents should have a person in charge of the inspector or test related bachelor's degree or more engaged in testing work for more than 3 years) business scope are involved in the need to meet the above personnel requirements), receive the original (1);
2. After the change in the business license (clear and complete)
3. Class III medical device license (recall the original), the original (1);
4. The operator's authorization certificate, the original (1);
5. proposed to increase the catalog of business varieties ([business varieties catalog should include the product name, manufacturer, specifications, product classification, registration number, and the corresponding product storage conditions, requirements, etc.);
6. the business scope of the proposed increase in the catalog of business varieties, including product name, manufacturer, specifications, product classification, registration number, and the corresponding Product storage conditions, requirements of the description of the content] and submit a copy of the corresponding real and effective registration certificate has been on-site verification). Involving changes in the storage area should also be submitted to change the storage materials. (Involving the provision of professional staff, the need to submit personnel qualifications), the receipt of the original (1);
6. After the change of the business license, the new legal representative or person in charge of the enterprise, a valid proof of identity, education or title certificate, the receipt of the original (1);
7. Medical device business license change application form (fill in the online (medical device production and operation licensing (for the record) information system:) 8800/sign_in), print, stamp), receive the original (1);
8. new business premises (warehouse) of the house property rights, the right to use the certificate. [business premises, (depot address) of the lease agreement ((lease term of more than one year) copies of the lessor's proof of ownership of the house and geographic location map, floor plan (indicating the area) drug companies also operating medical devices, should be set aside a special area for medical equipment or special library, and in the declaration of the information on the application form and the depot floor plan is clearly labeled with the location of the medical equipment special area or special library and the area of the]; commissioning Storage, should be submitted to the commissioned party signed a written agreement with a copy of the commissioned party, the commissioned party's medical equipment storage and distribution of enterprise record copies, the agreement should contain clear quality responsibility of both parties), the receipt of the original (1);
9. business mode change description, the receipt of the original (1);
10. "Medical Device Business License", the receipt of the original (1)
11. Basic information and functional description of the computer information management system, receive the original (1);
12. Operating quality management system, work procedures and other documents catalog, receive the original (1);
13. Operating and warehouse facilities, equipment catalog, receive the original (1);
14. Operating premises, warehouse address of the Geographic location map, floor plan, documents proving property rights or lease agreement (with documents proving property rights), receive a copy (1);
15. Business mode and scope of business description, receive the original (1);
16. Organizational structure and departmental setup description, receive the original (1);
17. Legal representative, person in charge of the enterprise, quality The person in charge of the valid proof of identity, education or title, receive a copy (1);
18. business license, receive a copy (1);
19. medical device license renewal application form, receive the original (1);
20. business premises and storage of the property rights of the house, the right to use the certificate, receive a copy (1);
21. Commissioned storage, should be submitted to the commissioned party signed a written agreement with a copy of the commissioned party's medical equipment storage and distribution of enterprise record copies, the agreement should contain a clear responsibility for the quality of both sides of the content of the receipt of a copy (1).
Second, the matter of fees:
No fee
Third, the processing time limit
Acceptance time limit: 5 working days.
Statutory processing time limit: 45 working days, rectification time limit is not counted.
Commitment processing time limit: 20 working days, the rectification time limit is not counted.
Four, address
Address: 1 Jinxiu Street, Chenggong New District, Kunming (Chunrong Street No. 1) Kunming Municipal Administrative Center, Comprehensive Services Building Comprehensive Window
Time: 9:00 a.m.-12:00 p.m. 13:00-17:00 p.m.
Five, consulting
On-site consulting: 1 Jinxiu Street, Chenggong New District, Kunming (Chunrong Street No. 1) Avenue No. 1 (Chunrong Street No. 1) Kunming Municipal Administrative Center Comprehensive Service Building Comprehensive Window
Online Consultation:/Home/Index
Telephone Consultation:67435615