Japanese regulation requires a Market Authorization Holder (MAH) located in
Japan for your products.
The MAH license has 3 levels which defines what classes of medical device can
be handled by the MAH:


Type 1 license: “Specially Controlled Medical Devices” and other low risk
devices (All classes of Ⅰ, Ⅱ, Ⅲ and Ⅳ)
Type 2 license : “Controlled Medical Devices” and lower risk devices
(Class Ⅰ and Ⅱ)
Type 3 license : “General Medical Devices”(ClassⅠdevices only)
The MAH is legally responsible for the device and adverse event reporting.....

株式会社医療機器法規制QMS研究所」”：“MiRQ" "Medical Devices Institute of RA & QMS Co., Ltd." .... Documentation translation into Japanese. ...
meddevmirq.com/EnglishHomePage20090717.aspx -