Designated Marketing Approval Holder
Foreign companies, who are trying to get an approval or certification for their product in Japan,
can obtain Approval / Certification directly (Foreign Restrictive Approval.)
However it is required to appoint a marketing approval holder (D-MAH) in Japan and only the marketing approval holder
is able to “marketing” the imported medical device (Pharmaceutical Affairs Law Article 19-2).
The company who obtained this approval is called “Foreign restrictive approval holder”
and the Designated Marketing Approval Holder is called “D-MAH".
D-MAH has to obtaining the license according to the classification of the product to be handled.