Japanese Agent Representation for Medical Products (D-MAH)

A D-MAH is a "designated market authorization holder"; a local agent. The D-MAH can must be located in Japan and meet other criteria. It is typically a Japanese distributor or an independent third party located in Japan. Foreign medical device companies may use a D-MAH if they export their products to Japan and do not have an office there.

A D-MAH, like a MAH, is considered fully responsible for the quality and safety of the foreign company's products. However, many foreign medical device companies choose to appoint a Designated Marketing Authorization Holder (D-MAH), rather than to appoint a distributor as their MAH for strategic reasons.  If a foreign medical device company appoints a distributor as their MAH, and their contract with the distributor terminates, they lose control of their Marketing Authorization Holder (because the distributor has it). If they use a D-MAH, then the foreign company may appoint a different distributor without an adverse limiting effect on its Japanese Marketing Authorization.

1. Importation of the products from a a foreign medical device company

2. Product registration

3. Product quality and safety assurance

4. Product storage in an establishment with MAH licensing

5. Product release to distributors or other sales groups

6. Post-market surveillance

No, the licenses differ and are dependent on various factors. For a foreign company without an office in Japan, the D-MAH will need to get an appropriate Japan D-MAH license to cover different products. For example, foreign medical device companies without an office in Japan will require a "medical device D-MAH".  Also, within each D-MAH license, there are specific sub-groups of categories that need to be obtained for different medical products. For instance, a foreign company selling IVD products would require separate and different D-MAH license.

A Japanese distributor

Advantages: Cost savings. The Japanese distributor DMAH will generally register your product for free, unless local clinical trials are required. After registration, a Japanese distributor DMAH is also normally willing to perform most of the DMAH services without any charges or fees because they expect the sale of the foreign medical device company's product to be profitable.

Disadvantages: The potential privacy risks associated with the company’s confidential information. A Japanese distributor acting as your DMAH may acquire knowledge on important facts such as product development and raw materials to register your product that may expose your intellectual property. Changing distributors in the future may be a challenging process. In the future you may be in a difficult situation if you decide to change distributors since your distributor currently holds your product licenses and provides DMAH services. In many instances, when the distributor DMAH suspects a loss in profitable business, they may not be inclined to transfer the foreign medical company’s product licenses to another DMAH in Japan. A “friendly” product license transfer from the initial distributor to another new distributor can be very expensive for the foreign medical device company or lead to your products not being registered in Japan, hence hurting your sales there.

An independent third party located in Japan

Advantages: Protecting the company’s confidential product information. By using an independent third party D-MAH, it will be easier to protect your company’s confidential product information, as the independent third party is not a manufacturer and would want to preserve its reputation in the marketplace. At least in theory, such information would be safer with an independent third party D-MAH than with a distributor D-MAH, who may be acquainted with other industry professionals working in the medical manufacturing field. Another advantage to this method is that switching distributors will be much easier if the registration is in the name of the third party D-MAH, rather than in the distributor's name.

Using an independent third party entity as a Japan DMAH will require payment for its D-MAH services, in addition to the registration costs. But all costs are itemized and explained. If your distributor acts as your D-MAH, the D-MAH costs will most likely be less transparent.

The foreign medical company’s subsidiary in Japan

Advantages: This is an effective route for mid-sized to large companies who already have their own offices in Japan.

Disadvantages: This option would be very difficult and expensive for smaller companies as the foreign medical company’s office must be located in Japan and must meet the MHLW’s  MAH standards.

Three controllers make up a MAH or DMAH, each with its own role in the supervision of marketing, manufacturing and release of the product: (1) General Manager; (2) Post Marketing Safety Controller; and (3) Quality Assurance Controller. All three MAH controllers are responsible for determining when and how to report adverse events to the PMDA.

1. General Medical Devices (Class I) can have a MAH established and managed by one person. This individual acts as all three Controllers and will carry out all obligatory duties.

2. Controlled Medical Devices (Class II) must have two people as MAH – one acts as the Post-Marketing Safety Controller while the other acts as the Quality Assurance Controller. Additionally, one of these two people will also need to serve as the General Manager.

3. Highly-Controlled Medical Devices (Class III and IV) must have three people for their MAH (General Manager, Quality Manager, Safety Manager), and each individual acts as one Controller.

After the product is registered in Japan, the range of services and costs of a D-MAH will vary depending on the foreign medical device company’s products in Japan. D-MAH fees may be a flat monthly rate, or a lower monthly rate plus a percentage of sales.

Current or expected sales in Japan may be one basis for foreign companies in developing their MAH or DMAH strategy:

Foreign medical device companies with annual sales less than $1 million may choose to nominate their Japanese distributor as their Japan DMAH (to avoid DMAH fees). If a foreign company falls into this lower sales bracket but is uncomfortable with sharing confidential product information with a distributor DMAH, they may decide not to enter the Japanese market at all.

Mid-sized foreign medical device companies with annual sales between $1-3 million in Japan who do not wish to set up their own office in Japan generally choose to pay the fees for an independent third party DMAH in order to retain their confidential information and to have more control over their product registration and marketing.

Foreign medical device companies with annual sales exceeding $3 million may decide to set up a branch office or subsidiary office in Japan and use their own employees to act as the MAH. However, setting up an office in Japan can be an expensive endeavor.