Class II medical devices are medical devices whose safety and effectiveness should be controlled. Including X-ray film machine, ultrasound, microscope, biochemistry instrument are classified as Class II medical devices.
"Supervision and Administration of Medical Devices Regulations" Article 30 provides that: engaged in the operation of Class II medical devices, by the business enterprise to the municipal people's government of the location of the food and drug supervision and management department for the record and submit the conditions of its conformity with the provisions of Article 29 of the Regulations.
"Supervision and Administration of Medical Devices Regulations" Article 29 provides that: engaged in the operation of medical devices, there should be with the scale and scope of business operations and storage conditions, as well as with the operation of medical devices and quality management system and quality management organizations or personnel.
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Expanded Information
Starting a Type II Medical device manufacturers must have the following conditions:
1, the person in charge of the enterprise should have a secondary school education or junior title or above.
2, the person in charge of the quality inspection organization should have a college degree or above or intermediate or above title.
3, the enterprise should occupy the corresponding proportion of the total number of employees above junior title engineers and technicians.
4, the enterprise should have the appropriate product quality inspection capabilities.
5, there should be with the production of products and the scale of production, warehousing sites and environment.
6, with the appropriate production equipment.
7, the enterprise should collect and save and enterprise production, business related laws, regulations, rules and relevant technical standards.
8, the production of sterile medical devices, should have a production site in line with the provisions of the
/baike.baidu.com/item/%E4%BA%8C%E7%B1%BB%E5%8C%BB%E7%96%97%E5%99%A8%E6%A2%B0/8544474 "target= "_blank "title="Baidu Encyclopedia - Class II Medical Devices">Baidu Encyclopedia - Class II Medical Devices