Operating Class II medical devices to which department

The operation of Class II medical devices should be filed with the municipal food and drug supervision and management department of the district where the record, fill out the Class II medical device business filing form, and submit the following information:

(a) a copy of the business license and organization code certificate;

(b) legal representative, the person in charge of the enterprise, the person in charge of quality of the identity of the proof, education or title certificate;

(3) organization and department setup description;

(4) business scope, business mode description;

(5) 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) a copy of;

(6) business facilities, equipment directory;

() (G) business quality management system, work procedures and other documents directory;

(H) proof of authorization by the operator;

(I) other supporting materials.