DMAH: Designated Marketing Authorization Holder-Summary Ver.
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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).

The Most Advantageous Market Entry Route

• Among the three main routes, the "Foreign Special Approval System" using a DMAH is the most strategically advantageous option.

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Why?

• It allows overseas manufacturers to secure the product's marketing approval for themselves
• This is possible without establishing a legal entity in Japan.
• Complex domestic regulatory affairs are outsourced to a specialized company (the DMAH).
• This is considered the most rational and superior route for many overseas manufacturers.

What is the DMAH System?

• Foreign Special Approval System:
  • A system that allows overseas medical device manufacturers without a business office in Japan to enter the market while holding the product approval themselves
  • https://www.pmda.go.jp/review-services/drug-reviews/foreign-mfr/0008.html 

 

• Designated Marketing Authorization Holder (DMAH):
  • When using this system, it is legally required to designate a DMAH. 
  • The DMAH must hold a Marketing Authorization Holder license. 
  • They are the entity responsible for all regulatory duties within Japan.

DMAH Responsibilities
The DMAH assumes full responsibility within Japan on behalf of the overseas manufacturer, including: 

• Carrying out procedures for obtaining product marketing approval
• Performing quality control (QMS) after approval
• Performing post-market safety management (GVP)
• Serving as the official liaison with regulatory authorities (like the PMDA)
  
  
  

Key Distinction: DMAH vs. MAH
The owner of the product approval is different:

• General MAH (Marketing Authorization Holder):
  • The MAH is the owner of the product's marketing approval.
• DMAH Model (Foreign Special Approval System):
  • The DMAH is not the owner of the product approval. 
  • The overseas manufacturer is the owner of the marketing approval.

Advantages of the DMAH Model

• Maintain Market Control: The overseas manufacturer holds the product approval, which is the greatest advantage.
• Flexible Sales Strategy: Approval is not tied to a specific sales partner, allowing you to appoint multiple distributors or change them freely.
• Reduced Cost & Time: Initial investment is significantly reduced compared to establishing a Japanese subsidiary, enabling faster market entry.
  
  

Disadvantages of Distributor as MAH Model

• The Risk: The distributor holds the product approval.
• Loss of Control: The manufacturer becomes dependent on the distributor.
• Switching Barriers: If you want to change distributors, you may restart the regulatory process from scratch with the new partner, costing time and money.
  
  

Disadvantages of Japanese Subsidiary Model

• This model requires enormous initial costs and time for
  • Establishing the company and office
  • Hiring specialized personnel required by the PMD Act
  • Obtaining the Marketing Authorization Holder license
  • The subsidiary must also be responsible for all product quality and safety post-market (in case of being MAH itself). 
• This is an extremely high barrier to entry, especially for SMEs and startups.

Key Steps Related to DMAH

• Select a DMAH Partner
  • This is the first and primary thing to do.
  • All applications to Japanese regulatory authorities must go through a licensed domestic entity, so you must select a DMAH and conclude a contract first.
• Foreign Manufacturer Establishment Registration (FMER)
  • Before the product approval application, the overseas manufacturing facility must be registered with the MHLW.
  • The DMAH usually handles this application on the manufacturer's behalf.
    
    

Key Criteria for Selecting a DMAH (1/2)

• Type and Scope of License:
  • Confirm the DMAH's license matches your product's classification.
    • Type 1: Class III & IV
    • Type 2: Class II
    • Type 3: Class I
• Experience and Expertise:
  • Check their track record with similar devices.
  • Verify they have experience negotiating with the PMDA.
  • Experience collaborating with overseas manufacturers is particularly important.

Key Criteria for Selecting a DMAH (2/2)

• Personnel Structure:
  • Verify they have qualified personnel for the "Three Roles" (San-yaku) required by the PMD Act.
• Communication Ability:
  • Assess their system for reporting and coordinating smoothly in foreign languages (e.g., English).
• Transparency of Fee Structure:
  • Confirm the fee structure is clear.
  • Monthly fixed costs (retainer fees) and variable costs (for applications, etc.) should be clearly distinguished.

Recommended Actions for Market Entry

1. Basic Understanding: Gather information on Japanese laws and regulations.
2. Confirm Product Class: Check your product's applicability and classification as a medical device/IVD roughly.
3. Select DMAH: Use web searches, events like Bio
4. Select Distributor (as needed): It is advisable to leverage the DMAH's network.

Others

• Special Case: Outsourcing to a Japanese Manufacturer
  • This applies if an overseas company outsources manufacturing to a domestic Japanese manufacturer.
  • The Japanese manufacturer requires a "Manufacturing License".
  • The QMS conformity assessment applies to the Japanese facility, not the overseas one.
  • A documented quality agreement between the DMAH and the domestic manufacturer is mandatory.
  • Consult with the DMAH first, about the appropriate scheme.​

​@K.Kamitani

Categorization of DMAH by backbone business