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DESIGNATED MAH

Choosing a Japan DMAH Agent: Roles, Requirements and Coordination

Written and edited by MK Consulting K.K.

A DMAH (Designated Marketing Authorization Holder) is a licensed Japanese Marketing Authorization Holder designated when an overseas manufacturer uses Japan’s foreign special approval or certification framework. A DMAH agent in Japan carries applicable regulatory, quality and post-market responsibilities; the term does not describe a representative that simply forwards documents. Whether this structure is appropriate depends on the product, application route and commercial arrangement.

Before appointment, manufacturers should review the DMAH requirements, the candidate’s license and product scope, contractual responsibilities, access to regulatory records, and arrangements for change control and post-market safety.

MK Consulting K.K. supports DMAH selection and coordination. We help identify appropriate licensed Japanese organizations and coordinate registration planning, QMS activities, contractual role allocation and post-market responsibilities with the manufacturer and candidate companies. We do not act as the DMAH or hold the relevant marketing authorization. An early discussion can help clarify the structure and information needed before approaching candidates.

Need to Select or Coordinate a DMAH in Japan?

The appropriate structure depends on the product, application route and commercial arrangement.

Discuss Your Japan DMAH Structure

We help plan foreign manufacturer registration, Japan submissions, and MAH/DMAH responsibilities.

ROLE

The DMAH Takes Responsibility in Japan for Marketing the Device

When a foreign manufacturer is the applicant for marketing approval or related authorization for a foreign-manufactured medical device, a Marketing Authorization Holder in Japan is designated as the DMAH. The DMAH is not merely a domestic contact point; it is responsible for regulatory authority communication and quality and safety management in Japan.

After the product is launched, the DMAH also monitors design and manufacturing changes, device problems, and safety information from overseas, and carries out the regulatory procedures and safety measures required in Japan.

MAH vs DMAH in Japan

A Marketing Authorization Holder (MAH) is the Japanese entity responsible for placing a medical device on the Japanese market under the normal domestic application structure. Depending on the product and regulatory pathway, the MAH applies for or holds the applicable approval or certification and performs the required quality and post-market activities in Japan.

A DMAH is used when a foreign manufacturer itself becomes the holder under Japan’s foreign special approval or certification framework and designates a Japanese MAH to perform the required activities in Japan.

A DMAH is therefore still a Japanese MAH. “DMAH” describes its designated role for the foreign holder; it is not a separate category of MAH license. The designated Japanese entity must hold the medical device MAH license appropriate for the products within its scope.

Is a DMAH the Same as a Japan DMAH Agent?

“Japan DMAH agent” is a common commercial search term used by overseas manufacturers, but the word “agent” can be misleading.

A DMAH is not merely a local representative that forwards documents to PMDA or other authorities. It performs the responsibilities required of the designated Japanese MAH, including applicable quality management, post-market safety management, regulatory communication, labeling and change control, and maintenance of regulatory records.

A regulatory consultant can support the manufacturer and the DMAH with regulatory strategy, submissions and authority communication. However, regulatory consulting and the legal DMAH role are not the same unless the service provider itself holds the required MAH license and is formally designated as the DMAH.

For post-market safety reporting, recalls, and change control in Japan, see Post-Market Safety Management for Medical Devices in Japan.

For the overall Japan market-entry process, see medical device registration in Japan.

RESPONSIBILITIES

Responsibilities Continue from Before the Application Through the End of Marketing

Approval and Certification Activities

Under a system in which the foreign manufacturer is the applicant, the DMAH performs the necessary activities in Japan as the designated Marketing Authorization Holder. Because the applicant differs from the usual structure in which a domestic Marketing Authorization Holder applies, the responsibilities should be defined according to the application structure.

Quality Management

The DMAH manages quality information from overseas manufacturing sites and handles release decisions and change control.

Post-Market Safety Management

The DMAH evaluates device problems and safety information from Japan and overseas and carries out reporting and safety measures.

Labeling and Package Insert

The DMAH manages labeling documents in accordance with the approval or certification content and Japanese requirements.

Communication with Regulatory Authorities

The DMAH serves as the domestic contact point for applications, QMS conformity assessment, inquiries, device problem reporting, and recalls.

Change and Renewal Management

The DMAH assesses how changes to design, materials, manufacturing sites, processes, labeling, and other elements affect Japanese regulatory procedures.

Typical DMAH Services and Support Scope

The exact scope depends on the product, regulatory pathway and contract. Typical DMAH services may include:

  • acting as the designated Japanese MAH under the foreign special approval or certification structure
  • communication with MHLW, PMDA and other relevant regulatory bodies as applicable
  • coordination of QMS and quality management activities in Japan
  • post-market safety management and vigilance activities
  • Japanese labeling and package insert management
  • regulatory change control and maintenance of required records
  • coordination of QMS conformity inspections and other regulatory inspections when applicable
  • coordination of recalls, field safety actions or other post-market measures when required
  • support for changes to or transfer of the DMAH arrangement

Foreign manufacturers should confirm which activities are included in the service fee, which activities require separate fees, who controls the regulatory documentation, and how records and responsibilities will be transferred if the DMAH is changed.

AGREEMENT

Items to Confirm Before Contracting with a DMAH

  • Scope of services

    Specify the responsibilities for applications, QMS, labeling, post-market activities, reimbursement, and logistics.

  • Information-sharing deadlines

    Define deadlines for reporting complaints, device problems, recalls, and design or manufacturing changes.

  • Access to documentation

    Ensure access to technical documentation, test reports, manufacturing records, and audit records.

  • Decision-making process

    Define the decision and approval procedures for application strategy, labeling, changes, device problem reporting, and recalls.

  • Fees and additional work

    Clarify additional fees associated with applications, inquiry responses, audits, recalls, and transfers.

  • Transfer at contract termination

    Define the conditions and schedule for transferring approvals or certifications, records, inventory, and post-market information.

SELECTION PROCESS

From Selecting Candidate Companies to Finalizing the Contract

  1. 01

    Define the Required Role

    Based on the planned product, application structure, and marketing plan, define the scope of work expected from the DMAH.

  2. 02

    Compare the Capabilities and Contract Terms of Candidate Companies

    Compare the types of products they can support, quality and safety management systems, access to documentation, fees, and transfer conditions.

  3. 03

    Finalize the Contract and Operating Procedures

    Document the allocation of responsibilities, communication deadlines, decision-making process, change and device problem handling, and record management.

    Foreign Manufacturer Registration Application

    Procedures and forms for foreign manufacturer registration of medical devices can be checked in PMDA's guidance.

    Open PMDA guidance (Japanese)
    PMDA — Regulations and Approval/Certification of Medical Devices
    PMDA — Frequently Asked Questions (FAQ)

COMMON PITFALLS

Common Points Overlooked When Selecting a DMAH

  • Not comparing the costs of post-market activities and change control
  • No deadline defined for sharing safety information from overseas
  • The DMAH cannot access application materials or QMS records
  • The roles and contact points of the distributor and DMAH are unclear
  • Design, material, or manufacturing-site changes are reported only after implementation
  • No conditions are defined for transferring approvals, certifications, or records when the contract ends

FAQ

Frequently Asked Questions About DMAHs

Is a DMAH the Same as an Importer or Distributor?

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Not necessarily. A DMAH is a designated Marketing Authorization Holder, while sales, logistics, and commercial activities may be handled by another company.

Can an Overseas Manufacturer Hold a Japanese Approval Directly?

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For applications for marketing approval of foreign-manufactured medical devices, there is a structure in which the foreign manufacturer is the applicant and designates a Marketing Authorization Holder in Japan. This differs from the usual structure in which a domestic Marketing Authorization Holder is the applicant, so the appropriate application structure should be confirmed based on the product and business plan.

If We Select a DMAH, Will It Prepare All of the Application Documents?

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The scope depends on the contract. Confirm whether the contract includes the application form, STED, test planning, inquiry responses, translations, and related work.

Can Product Changes Be Decided Solely by the Overseas Manufacturer?

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A procedure is needed to share information with the DMAH before implementation so that the impact on Japanese approval or certification, QMS, and labeling can be assessed.

Can the DMAH Be Changed?

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When only the DMAH changes and the foreign approval or certification holder remains the same, this is distinct from transferring the approval or certification to a different holder. Confirm the procedure for changing the designated MAH, the handover of records and post-market information, and the handling of inventory.

Reviewing an existing DMAH arrangement or document handover

Alongside initial selection, you can discuss role allocation in an existing arrangement and the points to clarify before a document handover. Share available product information, application or authorization status, contractual responsibilities, a list of held documents and the issue you need to resolve.

MK clarifies required documents, gaps and the scope for dossier preparation and inquiry response support. MK does not act as the MAH or DMAH, or as the applicant or license holder. Changes and handover of records, stock and post-market information require confirmation of the parties’ responsibilities, contracts and ability to act; this does not promise management of the entire transfer.

See MK’s dossier preparation and inquiry response support

CONTACT

Need to Select or Coordinate a DMAH in Japan?

The appropriate structure depends on the product, application route and commercial arrangement. MK Consulting K.K. helps review candidate organizations, clarify responsibilities and coordinate the Japan-side regulatory work.

Discuss Your Japan DMAH Structure