DMAH: Designated Marketing Authorization Holder
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​ ​-The most efficient entry pathway for foreign medical device & IVD firms

*Please note that the majority of references are in Japanese. This is due to accuracy and a significant lack of official documents available in English.
*Communication with regulatory authorities and other organizations is mostly in Japanese. Also, given the subtle nuances and business customs that are hard for non-Japanese to grasp, I recommend you to secure a Japanese person (even on a part-time or contract basis).

Among the three main routes for overseas medical device manufacturers to enter the Japanese market, utilizing the "Foreign Special Approval System" involving a DMAH (Designated Marketing Authorization Holder) is the most strategically advantageous option. The reasons become clear when compared to the other two models. Because it allows overseas manufacturers to secure the most crucial asset—the product's marketing approval—for themselves without establishing a legal entity in Japan, while outsourcing complex domestic regulatory affairs to a specialized company (DMAH), it can be considered the most rational and superior route to the Japanese market for many overseas manufacturers.


Foreign Special Approval System and Designated Marketing Authorization Holder (DMAH)
The Foreign Special Approval System is a system that allows overseas medical device manufacturers without a business office in Japan to enter the Japanese market while holding the product approval themselves. When using this "Foreign Special Approval System," it is legally required to designate a "Designated Marketing Authorization Holder (DMAH)," who holds a Marketing Authorization Holder license, as the entity responsible for regulatory duties within Japan.
The DMAH not only carries out the procedures for obtaining product marketing approval on behalf of the overseas manufacturer but also, after approval is obtained, performs quality control (QMS) and post-market safety management (GVP), serves as the official liaison with regulatory authorities (such as the PMDA), and assumes full responsibility within Japan.
The difference from a general MAH (Marketing Authorization Holder) is that whereas the MAH is the owner of the product's marketing approval (approval certificate/certification document), under the Foreign Special Approval System/DMAH model available only to overseas companies, the DMAH is not the owner of the product approval; the overseas manufacturer is the owner of the marketing approval.
Pharmaceuticals and Medical Devices Agency (PMDA) "Regarding Application for Registration of Foreign Manufacturers of Medical Devices, etc." https://www.pmda.go.jp/review-services/drug-reviews/foreign-mfr/0008.html 1

Advantages of the Foreign Special Approval System/DMAH Model
In this model, the overseas manufacturer itself holds the product approval. This is the greatest advantage and allows them to maintain control in the market. Since the product approval is not tied to a specific sales partner, they can implement flexible sales strategies, such as appointing multiple distributors or changing them freely based on performance. Furthermore, compared to establishing a Japanese subsidiary, initial investment can be significantly reduced, enabling faster market entry.

Disadvantages of the Model Where a Distributor Becomes the MAH
The biggest risk is that the distributor holds the product approval. This makes the manufacturer completely dependent on the distributor, losing control in the market. If they wish to change distributors, it is highly likely they will have to restart the product approval process from scratch with a new partner, forcing them to spend significant time and money, and temporarily withdraw from the market.

Disadvantages of the Model Where a Japanese Subsidiary is Established
While market control can be maximized, establishing the company, securing office space, and hiring specialized personnel required by the PMD Act, as well as obtaining the Marketing Authorization Holder license, require enormous initial costs and time. Furthermore, even after obtaining marketing approval, the MAH must be responsible for the product's quality and safety. These factors become extremely high barriers to entry, especially for small to medium-sized enterprises (SMEs) and startups that are not familiar with the Japanese market environment and lack resources.


Steps Related to DMAH
The first and primary thing to do is to select a DMAH.
Selection of a DMAH Partner
Since all applications to Japanese regulatory authorities must be made through a licensed domestic entity, the first step is to select a DMAH partner and conclude a contract.
Foreign Manufacturer Establishment Registration (FMER)
Prior to the product approval application, the overseas manufacturing facility itself that manufactures the product must be registered with the Ministry of Health, Labour and Welfare (MHLW). This procedure is called "Foreign Manufacturer Establishment Registration," and the DMAH usually handles the application through the PMDA on behalf of the overseas manufacturer.


Key Criteria for Evaluating and Selecting a DMAH Partner
When evaluating potential DMAH candidates, it is important to check the following points.

• Type and Scope of License: Confirm that the type of "Marketing Authorization Holder License" held by the DMAH corresponds to the classification of your product. A "Type 1" license is required for Class III and IV (Specially Controlled Medical Devices), "Type 2" for Class II (Controlled Medical Devices), and "Type 3" for Class I (General Medical Devices).
• Experience and Expertise: Check if they have a track record of obtaining approval for similar medical devices and if they have extensive experience negotiating with the relevant review divisions of the PMDA or specific third-party certification bodies. Experience collaborating with overseas manufacturers is particularly important.
• Personnel Structure: Verify that qualified specialized personnel who meet the requirements for the "Three Roles" (San-yaku) stipulated by the PMD Act—namely, the General Marketing Manager (Soukatsu Seizou Hanbai Sekininsha), the Quality Assurance Manager (Kokunai Hinshitsu Gyoumu Unei Sekininsha), and the Safety Management Manager (Anzen Kanri Sekininsha)—are appropriately assigned. These roles form the core of the DMAH's regulatory compliance capabilities.
• Communication Ability: Assess whether they have a system in place to report and coordinate smoothly and in a timely manner in foreign languages, such as English, regarding the progress of regulatory applications and post-market safety information. Close communication between the manufacturer and the DMAH is essential for rapid responses to inquiries from regulatory authorities.
• Transparency of Fee Structure: Confirm that the fee structure is clear. Monthly fixed costs (retainer fees) and variable costs for individual tasks such as applications and inspection responses should be clearly distinguished, and a detailed estimate should be provided.

​Recommended Actions for the Best Cost and Time Performance When Entering the Japanese Market
Basic Understanding of Japanese Laws, Regulations, and Market Environment

• Gather information from web.
• (If understanding is insufficient, seek free advice from public supporting organizations as needed.)

Confirm the Applicability of Your Product as a Medical Device and its Class

• If cost is not a concern, you may entrust this to a DMAH from this point.
• Check the "how to determine if a product is a medical device" on your own.
• If necessary, seek advice from public supporting organizations. 
• *Note: The final decision is made by the regulatory authorities.  You can't rely on anybody else!

Selection of DMAH

• Web search, networking at events.
• You can also ask help from consultants, or public organizations like embassies for business matching. 

Selection of Distributor (as needed)

• It is advisable to leverage the DMAH's network.
• Web search, networking at events.

Others
In Case of Outsourcing to a Japanese Manufacturer Instead of an Overseas Factory
When an overseas company outsources manufacturing to a domestic Japanese manufacturer to sell its own products, the basic framework is the same, but some procedures differ.

• The domestic Japanese manufacturer becomes a "Manufacturer" under the PMD Act (Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices) and requires a "Manufacturing License."
• The subject of the QMS (Quality Management System) conformity assessment, conducted as part of the product approval/certification review, becomes the outsourced Japanese manufacturing facility, not the overseas facility. It is mandatory to exchange documented agreements regarding quality control between the DMAH and the domestic manufacturer.
• Products manufactured at the domestic facility are shipped directly to distributors or medical institutions after undergoing the "Market Release Judgment" by the DMAH.
• Whether Foreign Manufacturer Establishment Registration (FMER) is necessary depends on factors such as which parts of the manufacturing process are outsourced to the Japanese manufacturer. Consultation with the DMAH is required.

@K.Kamitani
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Categorization of DMAH by backbone business