Support for obtaining and maintaining business licenses

To market a medical device in Japan, it is necessary to have the appropriate licenses.
Each license has requirements (e.g. personnel, facilities) that depend on the classification of the product submitted.  We provide consulting and preparation services for such licenses.

1) MAH (Marketing Authorization Holder)
Only companies who have a MAH license can apply for and obtain regulatory approval for medical devices. It is necessary to be licensed as a MAH in order to obtain medical device approval. Three qualified staff must be licensed, such as the general manager, the person in charge of quality control, and the person in charge of post-marketing safety.
Note: only companies legally registered in Japan can obtain a MAH license.

2) A-MAH (Appointed MAH)
If a foreign company intends to obtain medical device approval, it must find a MAH license-holder company and appoint that company as the A-MAH.
In this case, the foreign company can apply for and obtain approval, and have the A-MAH company represent it in Japan. The requirements for A-MAH status are the same as those for MAH.

3) Foreign manufacturer accreditation
A medical device manufacturer intending to export its medical devices to Japan (i.e. a foreign manufacturer) must be accredited by the Japanese authority. The relevant procedures can be carried out by a Japanese agent.

4) Medical device manufacturer warehouse
A medical device manufacturer license must be obtained for warehouses in Japan. A staff member in charge of quality control is also required.

5) Medical device retailer
A company that intends to sell medical devices to end users must be licensed as a retailer.
The difference between a MAH and a retailer:
A MAH is an approval holder and importer with responsibility for quality control and post-marketing safety. It imports medical devices and sells them through retailers.
(An A-MAH is a party that represents a foreign manufacturer as an approval holder, and is an importer with responsibility for quality control and post-marketing safety.).