In modern times, hospitals have a close relationship with people's lives and health. Because it involves the life and safety of patients, hospitals are also very careful when choosing medical devices. In our country, medical devices are also divided into Class I, Class II and Class III. Class I, Class II, Class III is a management category, is based on the supervision and management of medical devices regulations. So, what kind of difference is there between Class I, Class II and Class III medical devices?
Class I medical devices, usually refers to medical devices whose safety can be ensured through routine management. And Class II medical device mainly refers to medical devices whose safety and effectiveness are controlled. Class III medical devices are medical devices whose safety and effectiveness must be strictly controlled. Because Class III medical devices contain implanted in the human body, so the requirements must be more stringent, otherwise it will threaten our life and health safety.
Class I, medical devices generally include basic surgical knives. such as spatulas, lancets and so on. The second class of medical devices, including general diagnostic equipment class, operating room, emergency room, diagnostic room equipment and apparatus class. For example, thermometer, sphygmomanometer, condoms, etc. are all belong to the second class of medical devices. Class III, medical devices generally include single-use sterile medical devices, single-use sterile syringes, implanted prostheses and so on.
Because the use of medical devices is directly related to the life and health of patients. So the requirements for operating these medical devices are also very strict. If you want to operate Class III medical device products. Then you need to have a state-recognized, and business products related professional qualifications. And, the education is equivalent to a college degree or above or a professional intermediate title or above. Similarly, if you want to operate the second class of medical equipment products. You also need to have a nationally recognized degree related to the management of products. Compared to the third class of medical device products business qualification requirements, the second class of medical device products business qualification has been relaxed, not so strict.