Cosmetics and Medical Device
Registration Professional

We provide clients who are considering entering market
with the most cost and time effective methods.


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.


Medical Device Registration

In principle, it is necessary to take the same procedures as the drug registration, but the required time and procedure are comparatively short and simple.


Prior Certification Representation

The new amendment to the Pharmaceutical Affairs Law was enforced in April 2005, and for the Designated Controlled Medical Devices, certification (NINSYO) system is implemented.

Along with implementation of it, our company provides representative service for certification. Business contents are as follows.