The distinction between Class I, II and III medical devices is based on safety and effectiveness.
Class I medical devices are medical devices whose safety and effectiveness can be ensured through routine management. Class II refers to the control to ensure the safety and effectiveness of medical devices. Class III refers to, implanted in the human body, used to support, maintain life, the human body has the potential danger, its safety and effectiveness must be strictly controlled medical devices.
Medical device specifically refers to, alone or in combination with the use of the body's instruments, equipment, appliances, materials or other items, including the software required; it is used for the human body surface or in vivo to play a role is not through the means of pharmacology, immunology or metabolism, but there may be the participation of these means and play a certain role in assisting.
Extended information:
Class I medical devices are: basic surgical knives, including scalpel handles and blades, shaving knives, pedicure knives, dermatome shaving knives, picking knives, sharpening knives, and scalpels.
The second class of medical devices are: thermometers, sphygmomanometers, operating room, emergency room, diagnostic and treatment room equipment and appliances class, medical degreasing cotton, medical degreasing gauze, blood glucose analyzers and test strips for home use.
Class III medical devices include: single-use sterile medical devices, single-use infusion sets, single-use blood transfusion sets, single-use burette infusion sets, and single-use intravenous needles.
Baidu Encyclopedia---Medical Devices