1. The valid identity certificate, education background, professional title certificate and health certificate, work resume, resignation certificate, employment documents and employment agreement of the new quality director ((those who engage in planting intervention must have a college degree or above in medical related major and have been trained by the manufacturer or supplier; There should be 1 person engaged in in in vitro diagnostic reagents and engaged in inspection for more than 3 years, with bachelor degree or above in inspection or related major. The business scope should meet the requirements of the above-mentioned personnel at the same time. ) original (1 copy);
2. The changed business license (clear and complete), original (1 copy);
3. Class III medical device business license (original recovered), with the original attached (1 copy);
4. Agent's authorization certificate, with original copy (1 copy);
5. List of business varieties to be added ([The list of business varieties shall include product name, manufacturer, specifications, product classification, registration number, description of storage conditions and requirements of corresponding products, etc.). ] and submit the corresponding true and valid copy of the registration certificate, which has been checked on site). Where the area of the warehouse is changed, the materials for changing the warehouse shall also be submitted. If it involves the provision of professional personnel, it shall submit the personnel qualification) and receive the original (1 copy);
6. The changed business license, new legal representative or person in charge of the enterprise, valid identity certificate, and original certificate of education or professional title (1 copy);
7. Application form for change of medical device business license (filled online (medical device production and business license (filing) information system: 8800/sign_in), printed and stamped), and received the original (1 copy);
8. Proof of the property right and use right of the new business place (warehouse). [A copy of the lease agreement (with a lease term of more than one year) of the business premises and (warehouse address) of the enterprise, the property right certificate of the lessor's house, and the geographical location map and floor plan (indicating the area). Where a pharmaceutical trading enterprise concurrently engages in medical devices, it shall set aside a special area or warehouse for medical devices, and clearly mark the location and area of the special area or warehouse for medical devices on the application form and warehouse plan]; For entrusted storage, submit a copy of the written agreement signed with the trustee and a copy of the filing certificate of the medical device storage and distribution enterprise of the trustee, and the agreement shall include the content of defining the quality responsibilities of both parties), and receive the original (1 copy);
9. Description of the change of operation mode, with the original (1 copy);
10. Medical device business license, with original (1 copy);
1 1. Basic introduction and function description of computer information management system, with original (1 copy) received;
12. Directory of documents such as management quality management system and working procedures, with the original attached (1 copy);
13. Catalogue of operating and warehouse facilities and equipment, with the original attached (1 copy);
14. Geographical location map, floor plan, house title certificate or lease agreement (with house title certificate attached) of the business premises and warehouse address, with a copy (1 copy);
15. Description of business mode and business scope, with the original attached (1 copy);
16. Description of organizational structure and department setting, with original (1 copy);
17. Copies of valid identity certificates, academic qualifications or professional titles of the legal representative, person in charge of the enterprise and person in charge of quality (1 copy);
18. Business license with copy (1 copy);
19. Application Form for License Renewal of Medical Device Business Enterprises, with the original attached (1 copy);
20. Proof of the property right and use right of the house and warehouse, with a copy (1 copy);
2 1. Where storage is entrusted, a copy of the written agreement signed with the trustee and a copy of the filing certificate of the medical device storage and distribution enterprise of the trustee shall be submitted, and the agreement shall include the contents defining the quality responsibilities of both parties. Copies should be received (1 copy).
Two. Allegations on this matter:
be free of charge
Third, the processing time limit
Time limit for acceptance: 5 working days.
Legal processing time limit: 45 working days, excluding rectification time limit.
Time limit for commitment processing: 20 working days, excluding the time limit for rectification.
Four. Processing address
Address: the comprehensive window of the comprehensive service building of Kunming Administrative Center,No. Jinxiu Street 1 (Chunrong Street 1), Chenggong New District, Kunming.
Time: 9 am -65438+ 2 pm -65438+ 3 pm
Verb (abbreviation of verb) negotiation mode
On-site consultation: comprehensive window of comprehensive service building of Kunming administrative center,No. Jinxiu Street 1, Chenggong New District, Kunming (No.Chunrong Street 1)
Online consultation: /Home/Index
Telephone consultation: 674356 15