Processing conditions:
Engaged in the operation of medical devices, should have the following conditions:
(a) with the scope of business and the scale of operation of the quality management institutions or quality management personnel, quality management personnel should have a nationally recognized relevant professional qualifications or titles;
(b ) with the scope and scale of operation of the business, storage space;
(C) with the scope and scale of operation of the storage conditions, all entrusted to other medical device business enterprises can not set up storage;
(D) with the operation of the medical device quality management system;
(E) with the operation of the Medical devices appropriate professional guidance, technical training and after-sales service capabilities, or agreed to provide technical support by the relevant organizations.
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 products operated can be traced. Encouraged to engage in the first class, the second class of medical devices business enterprises to establish a computerized information management system in line with the quality management requirements of medical device business.
Required materials:
Engaged in the third class of medical devices business, business enterprises should be located in the municipal food and drug supervision and management department to apply, and submit the following information:
(a) a copy of the business license;
(b) legal representative, responsible person for the enterprise, the person in charge of quality of the identity of the person in charge of the identification, education or 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.
Note: engaged in the operation of Class II medical devices, the business enterprise should be located in the municipal food and drug supervision and management department for the record, fill out the Class II medical device business filing form, and submit in addition to the above materials in the eighth item.
Process:
For the applicant to apply for a Class III medical device license application, the municipal food and drug supervision and management department should be based on the following circumstances were dealt with:
(a) the application is within the scope of its competence, the application information is complete, in accordance with the statutory form, the application should be accepted;
(b) the application information is not complete or does not meet the statutory form, the application should be accepted;
(ii) the application information is not complete or does not meet the statutory form. complete or does not meet the statutory form, the applicant shall be informed on the spot or within five working days at a time of all the contents of the need to make corrections, late notification, from the date of receipt of the application information shall be accepted;
(c) application information there can be corrected on the spot error, the applicant shall be allowed to correct on the spot;