HOME最新トピックス医療機器許可の最新トピックス > 海外医療機器メーカーの日本進出(How to start selling medical devices in Japan)


海外医療機器メーカーの日本進出(How to start selling medical devices in Japan)

I would like to introduce how to start selling medical devices in Japan.


This video will be helpful for medical device manufacturing companies who have already been marketing medical devices out side of Japan and thinking of expanding business to Japan but they are not sure how to do that.


This slide shows necessary steps for start selling medial devices for foreign manufacturing company.

Step1 Survey

First of all, you need to have reserch on if your products are categorized as medical device in Japan or not.


Every medical device in Japan has caterogy name called JMDN code, so you need to identify which JMDN code are suitable for your products.


Also you need to search if similar products are already registered in Japan.

Step2 Getting necessary lisence

After you conduct research and decide to enter Japanese market, you need to get necessary lisence.


I will explain neessary lisence by using this chart.


This chart shows Flow of Medical device from manufacturing to use.


First, medical device are mainly assembled in a manufacturer and they are shipped to Japan and stored in a warehaouse in Japan.


And your products are finally released to the market by a company called marketing authorization holder in Japan.


Then, your products are distributed to dealers and reached to final users such us clinics or individuals.


If you are manufacturer who mainly assembled the products, you need to get Foreign manufacturer lisence. Also if you want to store your products and put package and labbeling, you need to get manufacturing licensse in Japan.


In addition, you need to get marketing license to import and market your products by yourself.


And if you want to sell your products directly to final users by a shop or online, you need to get selling license.

Step3 Product registration

After obtainig necessary license, you need to register your products one by one.


If you products are Class1, you just need to submit basic notification, so relatively easy.


But if your prducts are Class 2,3 or 4, you need to prepare many kinds of documents and testing reports.


Anyway, that medical device license system is much different from other countries.


I will upload many sereis of video about medical device system in Japan, so please Check!