What kind of license is necessary for importing and selling medical devices? 

In order to import and sell medical devices, a license for each business office should be obtained from the prefectural governor. Besides, an approval for manufacture (import) for each item should be obtained from the Minister of Health,Labour and Welfare, except for some medical devices. If wrapping, labeling, or storage operation is carried out after importation but before distribution, a manufacturing permit is also required.

1. To import and sell medical devices, a permit issued by a prefectural governor for manufacturing/selling business on a product-by-product basis is required. If wrapping, labeling, or storage operation is carried out after importation but before distribution, a manufacturing permit is also required. A permit application, including the application and other attached documents, should be submitted to the governor of the prefecture in which the business office resides, by way of the pharmaceutical affairs section of the prefectural administration. In addition, prior to customs clearance, documents including the import notification, with name and residence of the manufacturing/selling business entity and other items, must be submitted to either the Kanto-Shinetsu Regional Bureau of Health and Welfare, or the Kinki Regional Bureau of Health and Welfare.

2. Medical devices as a whole covers devices from band-aids with limited impact on the body to pacemakers with tremendous impact on the body. Examinations therefore cannot be conducted uniformly, and hence established is the tiered examination based on the risks the devices carry. Medical devices are classified into three categories (general medical devices, controlled medical devices and highly advanced controlled devices), and of the controlled medical devices, approvals for those which the Minister of Health, Labor and Welfare designated are issued by third-party approval agencies (general medical devices do not carry any approval requirements; highly advanced controlled medical devices carry requirements for approval by the Minister of Health, Labor and Welfare).
(Classification and examples)
General medical devices: surgical knives, tweezers, dental laboratory equipment
Controlled medical devices: MRI, ultrasonic diagnostic equipment, dental metal alloys
Highly advanced controlled medical devices: cardiac pacemakers, artificial heart valves, dialysis machines