Japan divides medical devices into four categories:
Category 1 is general medical equipment, that is, products with very low risk to the human body;
Category 2 is controlled medical devices, that is, products with low risk to human body. In the second category, the certification system is adopted, which does not require the approval of the minister of health, Labor and Welfare to determine the standards, and is verified by the third-party certification organizations (currently 13 organizations) that have been approved by the minister of Health, Labor and Welfare in advance.
The third category is highly regulated medical equipment, that is, products with relatively high risk to human body, which must be approved by the Minister of Health, Labor and Welfare (PMDA review);
Category 4 is highly regulated medical devices, which are highly invasive to patients and may directly endanger their lives, and require approval by the Minister of Health, Labor and Welfare (PMDA).
