Medical devices are divided into three categories:
The first category is a low degree of risk, the implementation of routine management can ensure its safety and effectiveness of medical devices.
The second category is a medium risk, need to strictly control the management to ensure its safety and effectiveness of medical devices.
The third category is a higher risk, need to take special measures to strictly control the management to ensure its safety and effectiveness of medical devices.
Magnetic **** vibration equipment belongs to the third class of medical devices.
Class II medical devices are:
X-ray film machine, ultrasound, microscope, biochemistry instrument and so on.
Class III medical devices include:
Implantable cardiac pacemakers, extracorporeal shock wave lithotripters, invasive patient monitoring systems, IOLs, invasive endoscopes, ultrasound scalpels, color ultrasound imaging equipment, laser surgery equipment, high-frequency scalpels, microwave therapy devices, medical magnetic **** vibration imaging equipment and so on.
Expanded Information
The conditions required for Class II medical devices:
(a) The person in charge of the enterprise should have a secondary school education or above, or a 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 above the junior title of engineering and technical personnel.
(d) the enterprise 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.
Baidu Encyclopedia - Medical Devices
Baidu Encyclopedia - Class III Medical Devices
Baidu Encyclopedia --Class II Medical Devices