Legal analysis: medical device license is a medical device business enterprises must have the documents, the opening of the second class of medical equipment business enterprises, should be to the provinces, autonomous regions, municipalities directly under the Central People's Government drug supervision and management department for the record; the opening of the third class of medical equipment business enterprises, should be by the provinces, autonomous regions, municipalities directly under the Central People's Government drug supervision and management department for review and approval, and issued the "Medical Device Business Enterprise License".
Legal basis: "Supervision and Administration of Medical Devices"
Article VII engaged in the operation of medical devices, shall 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 shall have a nationally recognized professional qualifications or professional titles;
(b) (ii) with the scope of business and the scale of operation of the quality management organization or quality management personnel, quality management personnel shall have nationally recognized professional qualifications or professional titles;
(b) ) has with the business scope and scale of operation of the business, storage premises;
(c) has 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) has with the operation of the medical device quality management system;
(e) has with the business 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 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 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 directory;
(viii) computer information management system basic information and functional description;
(ix) proof of authorization by the operator;
(x) other supporting materials.
Article IX for the applicant to apply for a Class III medical device license, the municipal food and drug supervision and management department shall be dealt with in accordance with the following:
(a) the application is within the scope of its competence, the application information is complete, in accordance with the statutory form, the application shall be accepted;
(b) the application information is incomplete or does not meet the statutory form, the application shall be accepted on the spot or in the statutory form, and shall be processed on the spot or at the same time. (b) the application information is incomplete or does not meet the statutory form, the applicant shall be informed on the spot or within five working days of all the contents of the need to make corrections, and if not informed after the deadline, the application shall be accepted from the date of receipt of the application information;
(c) the application information can be corrected on the spot, the applicant shall be allowed to make corrections on the spot;
(d) the application does not fall within the purview of the department, it shall make a decision of non-admissibility and inform the applicant of the decision to notify the applicant. Acceptance of the decision, and inform the applicant to the relevant administrative departments.
Settlement of municipal food and drug supervision and management departments to accept or not accept the application for a medical device license, shall issue a notice of acceptance or inadmissibility.