2, what are class II medical devices.
3, what is class II medical device products.
4, what is the meaning of class II medical device.
1. X-ray film machine, ultrasound, microscope, biochemical instrument belongs to class II.
2. Class II means that the safety and effectiveness of medical devices should be controlled.
3. The opening of the second class of medical device manufacturers must have the following conditions: (a) the person in charge of the enterprise should have secondary education or above, or more than junior title.
4. (B) the person in charge of the quality inspection organization should have college education or above, or more than intermediate title.
5. (C) the enterprise should occupy the corresponding proportion of the total number of employees above the junior title of engineering and technical personnel.
6. (D) The enterprise should have the appropriate product quality inspection capabilities.
7. (E) There should be and the production of products and scale of production, warehousing sites and environment.
8. (F) with the appropriate production equipment.
9. (VII) enterprises should collect and save and enterprise production, business-related laws, regulations, rules and relevant technical standards.
10. (H) the production of sterile medical devices, should have to comply with the provisions of the production site.
11. Extended information to start the second, third class medical device manufacturers, should be to the enterprise's location in the provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management department to apply, fill out the "Medical Device Manufacturer License (start-up) Application Form" (see Annex 2 of these methods), and submit the following materials: (a) legal representative, the person in charge of the enterprise's basic information and qualifications. .
12. (B) the administrative department for industry and commerce issued a notice of pre-approval of the name of the proposed enterprise.
13. (C) production site documents.
14. (D) enterprise production, quality and technical personnel in charge of the resume, education or title certificate.
15. Relevant professional and technical personnel, skilled workers registration form, and indicate the department and position.
16. Ratio of senior, intermediate and junior technicians table.
17. (E) the scope of products to be produced, varieties and related product profile.
18. (F) the main production equipment and inspection equipment catalog.
19. (VII) production quality management documents catalog.
20. (H) the proposed production of products and process flow diagrams, and indicate the main control items and control points.
21. (Ix) the production of sterile medical devices, should provide production environment test report.
22. The applicant shall be responsible for the authenticity of all the contents of its application materials.