1: Article 22 of the "Medical Device Business License" expires need to continue, medical equipment business enterprises should be in the expiry of six months before the expiry date, to the original licensing department to submit a "Medical Device Business License" renewal application.
Now your license is about to expire, not too good to do not be able to re-apply for a new one.
2: Article 8 engaged in the third class of medical equipment business, business enterprises should be located in the municipal food and drug supervision and management department to submit an application, and submit the following information:
(a) business license and organization code certificate copy;
(b) legal representative, responsible person for the enterprise, responsible for the quality of the person in charge of the identity card, education or professional title certificate Copies;
(C) organization and departmental setup description;
(D) business scope, business mode description;
(E) 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);
(F) business facilities, equipment directory;
(vii) business quality management system, work procedures and other documents catalog;
(viii) computer information management system basic information and functional description;
(ix) proof of authorization of the operator;
(x) other supporting materials.
3: If you are dealing with Class II medical devices, now managed by filing. The difference with the license is that you do not need the eighth item above: the basic information on the computer information management system and functional description.