Hello, Xiamen Dabo Yingjing Medical Devices Co., Ltd. holds a medical device production license No. 20090147
Product range: Class III 6846 implantable materials, Class II 6810 orthopedic surgery (orthopedic) surgical instruments, Class II 6826 physical therapy equipment, Class II 6865 medical suture materials, Class III 6810 orthopedic surgery (orthopedic) Surgical Instruments***
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Starting a Class II and Class III medical device manufacturer should do
(a) The person in charge of the enterprise's production, quality and technology should have the professional ability to adapt to the production of medical devices and master
National laws, rules and regulations on the supervision and management of medical devices As well as the relevant product quality, technical regulations. 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 requirements of the products
produced;
(c) the enterprise shall have the production equipment, production, warehousing sites and the environment that are compatible with the products produced and the scale of production. 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 production of products to be produced in the 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.