(a) a copy of the business license and organization code certificate;
(b) legal representative, responsible person for the enterprise, responsible person in charge of quality of the identity of the certificate, a copy of proof of academic qualifications or professional titles;
(C) organization and departmental setup description;
(D) business scope, mode of operation description;
(E) business premises, warehouse address geographic location map, floor plan, documents proving property rights or lease agreement (with documents proving property rights) a copy of;
(F) business facilities, equipment directory;
(VII) ) business quality management system, work procedures and other documents directory;
(h) computer information management system basic information and functional description; (two types of filing can be provided without)
(ix) proof of authorization of the operator;
(j) other supporting materials.
Article XVI of the "Medical Device License" matters of change is divided into changes in licensing matters and changes in registration matters.
License changes include business premises, business mode, business scope, warehouse address changes.
Registration changes refer to changes in matters other than the above.
Article XVII of the licensing matters change, should be made to the original licensing department, "Medical Device License" to change the application, and submit the provisions of Article VIII of these measures involves changes in the content of the relevant information.
Trans-administrative areas to set up warehouses, should be to the warehouse where the municipal food and drug supervision and management department for the record.
The original licensing department shall receive the application for change within 15 working days from the date of review, and make a decision to grant changes or not change; need to carry out on-site verification in accordance with the requirements of the Code of Practice for the Management of Quality of Medical Devices, from the date of receipt of the application for change 30 working days from the date of change to make a decision to grant changes or not change. Do not change, should be written and inform the applicant of the reasons. After the change of "medical device license" number and validity of the same.
Article XVIII of the newly established independent business premises, should apply for a separate medical device license or record.
Article XIX of the change in registration matters, medical equipment business enterprises should be timely to the municipal food and drug supervision and management department for change procedures.