1. business quality management system, working procedures and other documents directory (business quality management system, working procedures and other documents directory should include at least "medical device business quality management standard" requirements) The original (1 copy);
2. Operating and warehouse facilities, equipment catalog (table listing the name of facilities and equipment, quantity, purpose and other information.)
3. business mode and scope of business description (including the catalog of products to be operated, the catalog of products should include: product name, manufacturer, specifications, product classification, registration number, as well as the corresponding product storage conditions, requirements, etc., and at the same time the operation of the third and second class of medical devices, respectively, to produce a catalog; the product registration certificate should be true and within the validity period. 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 (stamped / clear, valid), collect the original (1);
7. "Medical Device License Application Form", collect the original (1);
8. business premises, warehouse address of the geographic location of the map, floor plan, documents proving ownership of the house or lease agreement (with documents proving ownership of the house) ([). Enterprise premises, warehouse 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) of the drug business enterprise also operates medical devices, should be carved out of the medical equipment special area or a special library, and in the declaration of the information on the application form and the warehouse floor plan is clearly marked on the location of the medical equipment special area or a special warehouse and area] entrusted storage, it should be (Submit a copy of the written agreement signed with the entrusted party, a copy of the entrusted party's medical equipment storage and dispensing enterprise filing certificate, the agreement should contain a clear quality responsibility of both parties). , receive the original (1 copy);
10. basic introduction and functional description of the computer information management system, receive the original (1 copy);
11. business premises, warehouse address of the geographic location of the map, floor plan, documents certifying the property rights of the house or lease agreement (with documents certifying the property rights of the house) (enterprise business premises, warehouse address of the lease agreement (lease term of more than one year)) Copies of the lessor's proof of ownership of the house and the geographic location map, floor plan (indicating the area) drug companies also operating medical devices, should be set aside for medical equipment special area or special library, and in the declaration of information on the application form and the warehouse floor plan is clearly marked on the location of the medical equipment special area or special library and area; entrusted to storage, should be submitted to the entrusted party to sign a copy of a written agreement, the entrusted party's medical equipment (The copy of the enterprise record certificate of proxy storage and distribution, the agreement should contain the content of the quality responsibility of both sides clearly.) (The copy (1);
12. Authorization of the operator (such as non-statutory representative of the person himself, should be submitted to the legal representative signed and stamped with the official seal of the operator's authorization certificate; legal person for the issuance of stamped with the operator's authorization certificate), receive the original (1);
13. Basic information on computer information management system and functional description (computer) Information management system and functional description of the basic information should be consistent with the requirements of the quality management standard for medical device business to ensure that the operation of the product can be traced), 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