Class I, Class II and Class III medical devices are classified according to their safety in use.
The first category refers to medical devices that can ensure their safety and effectiveness through daily management. Generally, it is approved by the US Food and Drug Administration and issued a registration certificate.
The second category refers to medical devices whose safety and effectiveness should be controlled. Generally, the provincial food and drug administration will approve and issue a registration certificate.
The third category refers to implantation into the human body; Used to support and sustain life; Medical devices that are potentially dangerous to the human body and whose safety and effectiveness must be strictly controlled. Generally, it is approved by the State Food and Drug Administration of the United States and issued a registration certificate.
However, the approval of medical devices is not fixed for life, but determined by their safety. The National Bureau has the right to change its classification. For example, masks are generally classified into one category, but they were classified into the second category during SARS!