1 is a general medical device, and it is considered that products with extremely low risk to human body even if adverse events occur, such as scalpels and in-vitro diagnostic equipment, do not need approval.
The second category is controlled medical devices, which are considered to have low risk to human body even if adverse events occur, such as electronic endoscopes and digestive organ catheters. In the second category, the system of non-governmental third-party certification institutions (existing 13 institutions) registered and accepted by the Minister of Health, Labor and Welfare in advance is adopted to certify that it meets the standards, without the approval of the Minister who determines the standards.
The third category is highly regulated medical devices, which are considered to be products with high risk to human body when adverse events occur. Such as dialyzers, artificial bones, artificial respirators, balloon catheters for cardiovascular diseases, etc. , must be approved by the Minister of Health, Labor and Welfare (PMDA Review).
The fourth category is highly controlled medical devices, which are highly invasive to patients. Once adverse events occur, they may directly lead to life-threatening products, such as pacemakers, artificial hearts and stents. It must be approved by the Minister of Health, Labor and Welfare (PMDA Review).