(a) with the scope of business and business scale of the quality management organization or quality management personnel, quality management personnel should have a nationally recognized professional qualifications or titles;
(b) with the scope of business and business scale of the business, storage space;
() (C) with the business scope and scale of operation of the storage conditions, all entrusted to other medical device business enterprise storage can not set up a warehouse;
(D) with the operation of the medical device quality management system;
(E) with the operation of the medical device appropriate professional guidance, technical training and after-sales service capabilities, or agreed by the relevant organizations Provide technical support.
Enterprises engaged in the operation of Class III medical devices should also have a computerized information management system that meets the quality management requirements for the operation of medical devices, to ensure that the operation of the product can be traced. Encouraged to engage in the first class, the second class of medical devices business enterprises to establish a quality management of medical equipment business in line with the requirements of the computer information management system.
Article VIII engaged in the operation of Class III medical devices, the business enterprise shall apply to the municipal food and drug supervision and management department of the location of the district and submit the following information:
(a) business license and organization code certificate copy;
(b) legal representative, responsible person for the enterprise, the person in charge of quality of the identity of the certificate, academic or professional title certificate Copies;
(C) organization and departmental setup description;
(D) business scope, business mode description;
(E) business premises, warehouse address geographic location map, floor plan, documents proving property rights or lease agreement (with documents proving property rights) copies;
(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.
Freda sincerely for your service.