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