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 firm/person with Japanese regulatory knowledge.

The Most Advantageous Market Entry Route

• Among several routes, the "Foreign Special Approval System" using a DMAH service is the most strategically advantageous option.
• Why?
  • It allows overseas manufacturers to secure the product's marketing approval for themselves (Under this system, an oversea manufacturer is called ”Foreign Special Approval Holder”). 
  • This is possible without establishing a legal entity in Japan. 
  • Complex domestic regulatory affairs are outsourced to a specialized company (Japanese firms who offer DMAH service).

What is DMAH?

• Foreign Special Approval System:
  • A system that allows overseas manufacturers without a business office in Japan to enter the market while holding the product approval themselves.
  • medical devices/IVDs
    • Article 23-2-17 (Marketing Approval for Medical Devices Produced in Foreign Countries)
    • https://www.pmda.go.jp/review-services/drug-reviews/foreign-mfr/0008.html
  • pharmaceuticals
    • Article 19-2 (Marketing Approval for Pharmaceuticals, Quasi-Pharmaceutical Products or Cosmetics Manufactured in Foreign Countries) ​
• Designated Marketing Authorization Holder (DMAH):
  • When using Foreign Special Approval System, it is legally required to designate MAH corresponding to the specific product category (Pharmaceuticals, Medical Devices, or IVDs) and its risk classification.
  • They are your representative in Japan, and responsible for all regulatory duties.
  • MAH Licenses
    • Medical Devices
      • First-class Medical Device MAH License: all medical devices from Class I to Class IV
      • Second-class Medical Device MAH License: Class I and Class II
      • Third-class Medical Device MAH License Class I only
    • In-Vitro Diagnostics (IVD)
      • IVD MAH License: all IVD
    • Pharmaceuticals
      • First-class Pharmaceutical MAH License: all pharmaceuticals
      • Second-class Pharmaceutical MAH License: Over-the-Counter (OTC) drugs and quasi-drugs, except prescription-only drugs

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 (GQP/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

• License Ownership & Control: The overseas manufacturer remains the official "Approval Holder." This prevents the risk of the product license being "held hostage" by a local partner.
• Sales Channel Flexibility: By decoupling regulatory responsibility from sales operations, the manufacturer can appoint, change, or manage multiple distributors freely.
• Cost-Effective Market Entry (vs. Setting up a Subsidiary): Eliminates the need to establish a physical office and hire full-time "Three Key Controllers" in Japan, significantly reducing fixed overhead and time-to-market compared to direct investment.

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.
  • Please refer to the following "Key criteria for selecting a DMAH".
• 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

• Type of MAH License:
  • Confirm their MAH license corresponding to your product category and class. 
• Personnel Structure:
  • Verify they have qualified personnel for the "Three Roles" (San-yaku) required by the PMD Act. 
  • Since these are prerequisites for the license, holding the appropriate MAH license means the requirements should be met.
• 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.
• 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

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

Categorization of DMAH by business origin