1. business quality management system, work procedures and other documents catalog, collect the original (1);
2. business and warehouse facilities, equipment directory, collect the original (1);
3. business mode and scope of business description (including the proposed business varieties catalog, business varieties catalog should include: product name, manufacturer, specifications, product classification, registration certificate number, and the corresponding product storage conditions, requirements of the description of the contents of the catalog at the same time, while operating the third category and the second category of medical devices, respectively, the catalog; product registration certificate should be true and within the validity period.) (Operating in the scope of implantation interventions need to be equipped with a college degree or above in medical-related professions, and after the production company or supplier training of qualified personnel; operating in vitro diagnostic reagents should have a person in charge of the examiner or testing related bachelor's degree or above engaged in testing work for more than 3 years) business scope are involved in the need to meet the above staff requirements.)
6. business license, collect the original (1);
7. "Medical Device License Application Form", collect the original (1);
8. new quality person in charge of the valid proof of identity, academic qualifications, titles and health certificates, work experience, proof of departure, appointment documents and employment agreement (the scope of business with implantation interventions need) Equipped with medical-related college degree or above, and after the production company or supplier training of qualified personnel; operating in vitro diagnostic reagents should have a person in charge of the inspector or test related bachelor's degree or above engaged in testing work for more than 3 years) business scope are involved in the need to meet the above personnel requirements), receive a copy (1);
9. After the change of business license (clear) complete), receive a copy (1);
10. Class III medical device license (recall the original), receive the original (1);
11. Manager's certificate of authorization, receive the original (1);
12. Proposed increase in the catalog of business varieties ([business varieties catalog should include the name of the product, the manufacturer, specifications and models, product classification, Registration certificate number, and the corresponding product storage conditions, requirements of the description of the content] and submit the corresponding true and effective copy of the 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), receive a copy (1);
13. After the change of business license, the new legal representative or person in charge of the enterprise, a valid certificate of identity, education or title certificate, receive a copy (1);
14. Medical device business license change application form (fill in the online (medical device production and operation licensing (record)) Information System:8800/sign_in), print, stamp), receive the original (1);
15. New business premises (warehouse) of the house property rights, proof of right to use. [Business premises, (warehouse address) of the lease agreement, receive a copy (1);
16. Change of business mode of information, receive the original (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