Flying speed medical equipment consulting for your service:
First of all, you need to understand the Gansu Province on the second class of medical equipment business filing of the relevant policies. Policies vary slightly from place to place and cannot be generalized.
Secondly, around the filing of the preparation of information are not very different, which should be able to find in Gansu Pharmaceutical Supervision Bureau.
Roughly:
1, fill out and print the "Class II Medical Device Business Record Form", the enterprise login to fill out, print and upload relevant information according to the prompt directory
2, business license and organization code certificate copy;
3, legal representative, responsible person for the enterprise, responsible person in charge of quality of the identity of the person in charge of the identity card, education or title certificate copy;
4, organizational structure and departmental setup description
5, business scope, business mode description
6, business premises, warehouse address of the geographic location of the map, floor plan, documents proving ownership of the house or a copy of the lease agreement (with documents proving ownership of the house);
7, business facilities, equipment directory;
8, the quality of operations Management system, work procedures and other documents directory;
9, the operator's authorization certificate;
10, computer information management system basic information and functional description (encouraging the second class of medical devices business enterprises to establish a computer information management system that meets the requirements of the quality management of medical equipment business, such as this, can be exempted from the description);
11, other supporting materials (such as the operation of in vitro diagnostic reagents, in vitro diagnostic reagents according to the standard requirements for the operation of medical testing personnel and cold chain facilities and equipment and other additional materials).
Note: Policies vary slightly from place to place, please decide on the ground situation. Can not find the provincial drug supervision hotline to consult.
Finally, according to the information released by the Drug Administration to the Drug Administration to apply for the first access to the documents, within three months of the Drug Administration teacher will be on-site review.
If there is still no understanding, please continue to ask questions.