X-ray film machine, ultrasound, microscope, biochemical instrument belongs to class II.
Class II refers to its safety, effectiveness should be controlled medical devices.
The opening of the second class of medical equipment manufacturers must have the following conditions:
(a) the person in charge of the enterprise should have secondary education or more junior title.
(B) the person in charge of the quality inspection organization should have college education or above, or intermediate or above title.
(c) the enterprise should occupy the corresponding proportion of the total number of employees of junior title or above engineering and technical personnel.
(d) enterprises should have the appropriate product quality inspection capabilities.
(E) should be compatible with the production of products and scale of production, warehousing sites and environment.
(F) has the appropriate production equipment.
(vii) The enterprise shall collect and save the laws, regulations, rules and relevant technical standards related to the production and operation of the enterprise.
(viii) the production of sterile medical devices, should have a production site in line with the provisions.
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Expanded Information
Starting a Class II, Class III medical device manufacturers, should be 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 measures), and submit the following materials:
(a) legal representative, the person in charge of the enterprise's basic information and proof of qualifications;
(ii) Administration for Industry and Commerce issued a notice of pre-approval of the name of the proposed enterprise;
(iii) production site documents;
(iv) enterprise production, quality and technical personnel in charge of the curriculum vitae, academic qualifications or title certificates; relevant professional and technical personnel, skilled workers registration form, and indicate the department and position; senior, intermediate and junior technical personnel ratio of the situation table;
(v) the scope of products to be produced, varieties and related product profile;
(vi) the main production equipment and inspection equipment catalog;
(vii) the production of quality management documents catalog;
(viii) the production of products to be produced by the process flow diagram, and indicate the main control items and control points;
(ix) the production of sterile medical devices, shall provide Production environment test report.
The applicant shall be responsible for the authenticity of all contents of its application materials.
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