Market Authorization Holder (MAH) / Designated Market Authorization Holder (DMAH) Business

We have first class medical devices marketing license.As a Market Authorization Holder (MAH) or Designated Market Authorization Holder (DMAH), all of the medical device classes are included in our service.

What is DMAH?

Designated Market Authorization Holder
When a foreign manufacturer doesn’t have a Japanese subsidiary office to sell medical devices in Japan, the manufacturer is required to designate a company that has a medical devices marketing license. Such designated company is called DMAH.

Why DMAH is necessary?

In Japan, medical device market authorization holders are required to practice the following operations.

1. Quality management of products (QMS)
2. Safety management after sales (GVP)

In 2005 the Foreign Special Approval System was enacted with the Pharmaceutical Affairs Law of Japan. By this rule a foreign medical device manufacturer can directly file an application for approval to the Ministry of Health, Labor and Welfare (MHLW) and hold a marketing approval (SHONIN or NINSHO) of medical devices on the condition that the foreign manufacturer designates a domestic (Japanese) company which holds a medical device marketing license.

Are MAH agency services also available for domestic manufacturers?

We do business not just only with foreign manufacturers but also domestic manufacturers. We practice the role of MAH on behalf of domestic manufacturers or distributors.
Please feel free to consult with us when you have questions such as;
"I manufactured a medical device but I don't have a medical device marketing license."
"I am considering entering the medical device business, but I don't know what is needed."

MAH/DMAH’s Business Model

Advantages of outsourcing MAH and DMAH

The following procedures must be carried out in order to conduct medical device sales and marketing operations.

All of these are legal requirements and it takes a lot of effort and money to carry out.

However, outsourcing of these operations will help you to reduce a great number of human resource issues, costs and labor.

Medical devices are always facing various problems. As the strength of our company, we collaborate with our parent company. Expartner Japan Co., Ltd., a regulatory consulting company, when these problems occur.

Fixed monthly fee (license fee) system

Our fee of DMAH or MAH is a fixed monthly fee (license fee).

Consents of License Fee

1. DMAH (MAH) general operation
   Quality control operation (QMS operation)
   Post-market safety operation (GVP operation)
2. One unit of a license fee is counted for a product (For example 3 products will be counted as 3 units of a license fee)

“License Fee” doesn’t change with purchase quantity and the total amount of invoices.

The license fee will be determined after consulting with our client based on the nature of the product, risk analysis, failure probability and annual shipment quantity.

The following services are also available upon request (Additional fee will be applied.).

Example of additional services

1. Individual shipping to each store, etc.
2. Manufacturing operations (storage of final products)
   Inspection/Labelling/Attaching of the “Package Insert”/ Inventory Management, etc.

If you have any other request, we would be glad to help you.

※Manufacturing operation fee varies depending on the product and procedure. Please contact us for details.