The first class of medical device manufacturers
Starting the first class of medical device manufacturers, should have with the production of products compatible with the production conditions, and should be in the receipt of business license within 30 days, fill out the "first class of medical device manufacturer registration form" to the location of the provinces, autonomous regions, municipalities directly under the Central Government (food) drug Supervision and management department in writing.
The second class, the third class of medical device manufacturers
(a) the enterprise's production, quality and technical personnel should have the production of medical devices and the production of appropriate professional competence, and master
State laws, rules and regulations relating to the supervision and management of medical devices, as well as related product quality, technical provisions. The person in charge of quality shall not
simultaneously serve as the person in charge of production;
(b) the proportion of technical personnel with junior title or technical secondary education or above in the enterprise shall be compatible with the production of products
requirements;
(c) the enterprise shall have the production of products and production scale of the production of equipment, production, warehousing sites and environment. Enterprises
Enterprise production of medical devices have special requirements for the environment and equipment, 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 laws and regulations, rules and regulations and relevant technical standards (E) the enterprise shall keep and medical device production and operation of relevant laws, 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, should also have the following conditions:
(a) in line with the quality management system requirements of the internal auditor of not less than two;
(b) the relevant professional title above the intermediate level or college education of not less than two full-time technical staff.
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 department issued a notice of pre-approval of the name of the proposed enterprise ;
(iii) documents proving the production site;
(iv) 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 and skilled workers
with departments and positions indicated; the ratio of senior, intermediate and junior technicians in the table;
(v) the scope of the products to be produced, varieties and related products;
(F) the main production equipment and inspection equipment catalog;
(VII) the production of quality management documents catalog;
(VIII) the proposed production of products and 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.