Class II Medical Devices refers to the need for its safety, effectiveness should be controlled medical devices, in general, the product mechanism of Class II Medical Devices has achieved international and domestic recognition, mature technology.
Class II medical devices include thermometers, sphygmomanometers, electrocardiographic diagnostic instruments, medical cotton wool, medical gauze, thermostatic incubators, glass cupping, X-ray film machine, ultrasound, microscope, biochemistry and so on.
What is included in Class II medical devices
X-ray film machine, ultrasound, microscope, biochemical instrument belongs to Class II.
Class II refers to medical devices whose safety and effectiveness should be controlled.
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 above the intermediate 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.