Category 1 is general medical devices, which are considered to be products with extremely low risk to human body even if an adverse event occurs, such as scalpels, in vitro diagnostic equipment that do not need to be approved etc.
Category 2 is controlled medical devices, products that are considered to have a relatively low risk to humans even if an adverse event occurs, such as electronic endoscopes and catheters for digestive organs. In Category 2, a system has been adopted whereby private third-party certification organizations (currently 13 organizations), which are registered and accepted by the Minister of Health, Labour and Welfare in advance, certify compliance with the standards without the approval of the minister who determines the standards.
Category 3 is highly regulated medical devices, which are considered to be products that pose a relatively high risk to the human body in the event of an adverse event. For example, dialyzers, artificial bones, artificial respirators, and balloon catheters for cardiac vessels are subject to approval by the Minister of Health, Labor and Welfare (PMDA review).
Category 4 is highly regulated medical devices, which are products that are highly invasive to patients and have the potential to directly cause life-threatening injuries in the event of an adverse event, such as pacemakers, artificial hearts, and stents. It is subject to approval by the Minister of Health, Labor and Welfare (PMDA review).