A. Conditions
Engaged in the operation of medical devices, should have the following conditions:
(a) with the scope of business and scale of operation of the quality management organization or quality management personnel, quality management personnel should have a nationally recognized professional qualifications or professional titles;
(b) with the scope of business and Business scale of the operation, storage space;
(C) with the scope of operation and business scale 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 device with the appropriate professional Guidance, technical training and after-sales service capacity, or agreed by the relevant organizations to 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 products operated 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.
Second, the 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, the person in charge of the enterprise, the person in charge of the quality of the identity of the certificate, education or title Proof of copy;
(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 lease agreement (with documents proving ownership of the house) copy;
(F) business facilities, equipment directory;
(F) business facilities, equipment inventory;< /p>
(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, business enterprises 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 of the eighth item.
Three, the process:
For the applicant to apply for a Class III medical device license, 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 line with the statutory form, the application shall be accepted;
(b) the application Information is incomplete or does not meet the statutory form, the applicant should be informed on the spot or within five working days of all the contents of the need to make corrections, late notification, from the date of receipt of the application information is accepted;
(c) application information can be corrected on the spot there are errors, the applicant should be allowed to make corrections on the spot;
(d) the application does not fall within the scope of this department Terms of reference, shall immediately make a decision of inadmissibility, and inform the applicant to the relevant administrative departments.
The municipal food and drug supervision and management department acceptance or inadmissibility of the application for a medical device license, shall issue a notice of acceptance or inadmissibility.
Four, the time limit:
The municipal food and drug supervision and management departments should be accepted within 30 working days from the date of application for review, and in accordance with the requirements of the quality management standard for the operation of medical devices to carry out on-site verification. The need for rectification, rectification time is not counted in the audit time limit.
Meet the prescribed conditions, according to law to make a written decision to grant permission, and within 10 working days to "medical device license"; does not meet the prescribed conditions, make a written decision not to permit, and the reasons.
V, medical device license is valid:
Valid for 5 years. Contained in the license number, enterprise name, legal representative, responsible person, residence, place of business, mode of operation, scope of business, depot address, licensing department, date of issue and expiration date and other matters. Medical device business record certificate shall contain the number, enterprise name, legal representative, person in charge of the enterprise, residence, place of business, mode of operation, business scope, depot address, filing department, filing date and other matters.
Legal basis:
"Supervision and Management of Medical Device Business" Article 7 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 should have a nationally recognized professional qualifications or titles; (b) with the scope of business and the scale of operation of the business, storage and storage of the business shall be suitable for the business. (B) with the scope and scale of business operations, storage space; (C) with the scope and scale of business storage conditions, all entrusted to other medical device business enterprise storage can not set up a warehouse; (D) with the operation of medical devices appropriate quality management system; (E) with the operation of medical devices appropriate professional guidance, technical training and after-sales service capabilities, or agreed to by the relevant agencies to provide technical support. Provide technical support. Enterprises engaged in the operation of Class III medical devices should also have to meet the requirements of quality management of medical devices business computer information management system to ensure that the operation of the product can be traced.