Need MAH License (Type 1, 2 and 3)

MAH is a marketing authorization holder and can only market medical devices in Japan

Need Manufacturer Registration

"Manufacturer" is not a same meaning outside of Japan and is an organization manufacturing medical devices

In case of foreign manufacture, need Foreign Manufacturer Registration

Need Repairer License for applied 9 categories

Only licensed repairer can repair medical devices manufactured outside of Japan though domestic manufacturer can repair medical devices by themselves without repairer license

Need Distributor Registration

or License for handling a Highly Controlled Medical Device and/or a Specially Designated Maintenance Control Required Medical Device