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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 (MAH) in Japan and only
the marketing approval holder is able to gmarketingh the imported medical device) (Pharmaceutical Affairs Law Article 19-2).

The company who obtained this approval is called gForeign restrictive approval holderh
and the Appointed Marketing Approval Holder is called gAMAH".

AMAH has to obtaining the license according to the classification of the product to be
handled.