One, how to apply for a medical device license
"Medical Device License Application Form";
Administration for industry and commerce issued by the pre-approval of the enterprise name documents;
Proposed quality of the business enterprise ID card, academic qualifications, copies of professional title certificates and personal resume of the administrator;
The organization and functions of the proposed enterprise;
The registered address of the proposed enterprise, the warehouse address of the geographic location map, floor plan (with area), a copy of the certificate of property rights of the house (or lease agreement);
The proposed enterprise product quality management system documents and storage facilities, equipment inventory;
Proposed enterprise quality management system;
Proposed enterprise quality management system documents and storage facilities, equipment directory;< /p>
The business scope of the proposed enterprise.
With quality management organization or full-time quality manager appropriate to the scale and scope of business. Quality management personnel should have a nationally recognized relevant professional or professional title;
with business norms and business scope of the relatively independent premises;
with business norms and business scope of the storage conditions, including storage facilities, equipment, in line with the requirements of the characteristics of the medical device products;
should be established and sound product quality Management system, including procurement, purchase and acceptance, warehousing and storage, out of the warehouse review, quality tracking and quality of bad time reporting system;
Should have the appropriate technical training and after-sales service capabilities of its medical device products, or agreed by the third party to provide technical support
Two, the medical device production license
Medical device manufacturing license is Medical device manufacturers must hold a document, issued by the local Drug Administration audit. The opening of medical device manufacturers should be in line with national medical device industry development planning and industrial policy. The State Food and Drug Administration should be in accordance with the "supervision and management of medical devices regulations" of the provisions of the start-up conditions of medical device manufacturers to make specific provisions for different categories of medical devices to develop appropriate quality management standards for the production of medical devices, and organization and implementation.
The second class, the third class of medical device manufacturers
(a) the production of enterprises, quality and technical personnel should have the production of medical devices and the production of appropriate professional competence, and to master the national supervision and management of medical devices, laws, rules and regulations, as well as related product quality, technical regulations. The person in charge of quality shall not be concurrently responsible for the production;
(2) the enterprise above junior title or technical personnel with secondary education or above as a proportion of the total number of employees should be compatible with the requirements of the products produced;
(3) the enterprise should have with the products produced and the scale of production and production of equipment, production, warehousing sites and the environment. Enterprises producing medical devices have special requirements for the environment and equipment, etc., should be in line with national standards, industry standards and relevant state regulations;
(d) the enterprise should set up a quality inspection organization, and with the production of varieties and production scale of the quality inspection capabilities;
(e) the enterprise should be preserved with the production and operation of medical devices related to the laws, rules and regulations, rules and Relevant technical standards.
The opening of the third class of medical device manufacturers, in addition to the above requirements should be met, but also should have the following conditions:
(a) meet the requirements of the quality management system of the internal auditor not less than two;
(b) the relevant professional title above the intermediate level or college degree or above of full-time technical staff not less than two.
To start the second, third class medical device manufacturer, should fill out the "Medical Device Manufacturer License (start-up) Application Form" and submit the following materials:
(a) legal representative, the person in charge of the enterprise's basic information and proof of qualifications;
(b) industrial and commercial administration issued by the proposed pre-approval of the name of the enterprise notification;
(C) documents proving the production site;
(D) resume, education or title certificates of the person in charge of production, quality and technology of the enterprise; registration form of relevant professional and technical personnel, skilled workers, and indicate the department and position; the ratio of senior, intermediate and junior technicians table;
(E) the scope of the products to be produced, varieties and related product profile;
(F) the main production equipment and inspection equipment catalog;
(VII) the production of quality management documents catalog;
(VIII) the proposed production of products, process flow diagrams, and indicate the main control items and control points;
(IX) the production of sterile medical devices, should provide the production of environmental testing reports.
The applicant shall be responsible for the authenticity of all contents of its application materials.