All medical devices for sale in the Canadian market, whether locally produced or imported, must be licensed by Health Canada, the Canadian medical device authority. Canadian medical device management implements product registration system. Different from the United States Food and Drug Administration (FDA) government's focus on the whole, that is, the government's product registration plus the government's on-site review (GMP review), and also different from the European complete third-party notified body inspection system (CE certification), Canada implements the government registration combined with the third-party quality system review system. The third party mentioned here refers to the third party organization recognized by Canadian medical devices conformity, hereinafter referred to as cmdcas accreditation organization. According to Canadian medical device regulations, medical devices are divided into four categories: I, II, III and IV. according to the risk size, class I device is the lowest risk, and class IV device is the highest risk.