: with the business scope and 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. Required materials: a copy of the business license; legal representative, the person in charge of the enterprise, the quality of the person in charge of the identity card, a copy of the certificate of academic qualifications or titles, etc..
Expanded Information:
Processing conditions:
To engage 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 organization or quality management personnel, quality management personnel should have a nationally recognized relevant professional qualifications or titles;
(b) with the scope of business and the scale of operation Appropriate business, storage space;
(C) with the scope of business and business scale of 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 with the appropriate professional guidance, Technical training and after-sales service capacity, 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 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.
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 of the house) copies;
(F) business facilities, equipment directory;
(vii) business quality management system, work procedures and other file directory;
(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.