What kind of operations are available in your company as an Agency Service of MAH or DMAH?

Following operations are available in our company.
・Decision of market release of the product
・QMS, GVP operation (Quality control, production control, post-sales safety management)
・Shipment to designated sales distributors
・Importation from the foreign manufacturer
・QMS operation for the foreign manufacturer

How the fee system is working?

The basic fee is “fixed license fee” that is applicable to QMS and GVP operations.
Our fee is far less compared to establishing your own MAH setup including marketing license, cost of human resource and infrastructure.

Which medical device classes are included in your service?

Since we have a first-class medical device marketing license, from ClassⅠto Class Ⅳ,service for all kinds of medical devices is available in our company.

We plan to obtain our own marketing license in the future. In that case can you return the marketing approval of the product?

We can transfer the approval of medical devices class II and higher. In the case of class I medical device, you will need to make a new notification, and we will provide you a copy of our notification documents.

We are totally new in to medical device business and we don’t have knowledge about Japanese legal obligations a market. Can you support us until we actually sell our product?

Yes, in cooperation with our parent company EXPARTNER JAPAN Co.,Ltd., we will be responsible for supporting you with consulting and document preparation from registration of marketing license to obtaining product approval, importing of your product and shipping when it's needed. So please rest assured.

First of all, there’s something we would like to consult with you. Will we be charged any fee for such consultation?

There won’t be any charge before signing an agreement. So please feel free to contact us.