HOME最新トピックス医療機器許可の最新トピックス > How to expand medical device business to Japan DMAH (医療機器事業を日本へどう拡大するか)


How to expand medical device business to Japan DMAH (医療機器事業を日本へどう拡大するか)

Hi, this is Seika from support Gyoseishosi Law Firm.

Thank you for watching this seminar video.

Today I would like to introduce another way for forein meidcal device manufacturers to expand business to Japan.

1. 2 ways to start selling medical device to Japan MAH and DMAH

To start selling medical device to Japan, you have 2 ways.

One is to become MAH.

MAH: getting manufacturing license by yourself and become Marketing Authorization Holder, MAH in short.

In order to become MAH, you need to have branch office in Japan and hire employees such as marketing directors, quality managers and safety managers.


Another way is using DMAH.

DMAH is selecting one Japanese company who has market responsibility for your products.

The selectd one compnay is called Designated Marketing Authorization Holder and they need to have marketing license in Japan.

Forein manufacturers can be license holder for medical device approval and outsource marketing related activity to DMAH.

2.Difference from European authorized representative

DMAH is close concept for European authorized representative, but DMAH has much responsible.

For example, DMAH need to receive complaints from customers and cope with them and give feed back to forein manufacturers.

Also, they need to deal with recalls and report it to government.

On the other hand, European authorized representative is more like first contact person of government and just controll documents.

3.Advantage and disadvantage for using DMAH


Reduce cost and time for getting marketing license in Japan by your self.

As I menioned the previous video, getting necessary licenses are quite hard for foreign companies because you need to hire many resposible people and rent office in Japan.

So by using DMAH, you do not need to spend time for looking for employees or office.



Higher cost for importing medical device.

You need to pay fees for each imported product.

So it costs more for foreign manufacturers on the long perspective.


To sum up, in order to market your products, you need to be MAH or decide one DMAH in Japan.

DMAH has more responsibility than European authorized representative, so you please be careful about that.

I will continue uploading many seminar videos , so do not forget to check.