Japan MAH & DMAH for Medical Devices
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Choose the Japanese marketing-authorization structure and define quality, safety, evidence and local commercial interfaces before filing.
Japan MAH versus DMAH: select the authorization structure first
Japan requires an appropriate domestic marketing-authorization structure for medical-device supply. A Marketing Authorization Holder (MAH) is a licensed Japanese entity with defined quality and safety responsibilities. A Designated Marketing Authorization Holder (DMAH) performs specified domestic functions in the applicable foreign-holder arrangement. Neither is simply a generic name for any distributor.
The PMDA device-route overview and official foreign-holder/DMAH explanation help distinguish the structures. Determine the eligible model before assuming who will hold the product authorization or control future changes.
MAH and foreign-holder/DMAH comparison
| Decision | Conventional MAH structure | Applicable foreign-holder/DMAH structure |
|---|---|---|
| Authorization model | Japanese MAH holds the applicable marketing authorization | Eligible foreign holder uses a designated licensed Japanese MAH for required domestic functions |
| Domestic quality/safety | MAH performs the required functions | DMAH performs the designated domestic functions; foreign-holder duties remain |
| Evidence access | Agreement with manufacturer supports the MAH obligations | Foreign holder and DMAH define access, decisions and communications |
| Distribution | Commercial model can be separate | Commercial model can be separate |
The appropriate structure depends on the actual notification/certification/approval route and parties. Confirm eligibility and current requirements with the Japanese regulatory team; a label such as “independent DMAH” does not itself settle the authorization model.
Route and site requirements remain separate
Use Japan classification to confirm JMDN, class, certification standards and the applicable notification, Registered Certification Body or MHLW/PMDA approval pathway. IVDs and specialized products need their own route analysis. A foreign FDA or EU authorization does not replace it.
Assess foreign manufacturing-site registration and the relevant Japanese QMS conformity requirements. A product decision, a site registration and a MAH business licence are distinct records. Reconcile legal names, sites, processes, device categories and responsibility for keeping each record current.
What the agreement should make operational
| Interface | Questions to resolve before filing |
|---|---|
| Dossier and consultation | Who controls the file, signs submissions and approves responses? |
| Release and quality | Who verifies the configuration, site evidence and release conditions? |
| Safety | How do complaints, reportable events and field actions reach the responsible people? |
| Changes | Who decides the regulatory impact and prevents premature implementation? |
| Commercial handover | What records, approvals, labels and inventory must transfer if the arrangement changes? |
Define access to Japanese translations and source evidence, confidentiality, escalation times, backups and record retention. A distributor’s commercial rights should not silently prevent the regulatory role from obtaining technical or safety information.
Plan lifecycle and transfer work from the start
Maintain the authorized device scope, Japanese product information, quality records and manufacturing sites. Software, intended-use, design or site changes may affect the product authorization and require assessment before implementation. An appointment alone does not complete those changes.
For a transfer or new distributor, assess the applicable product, site, licence and local-record procedures and how safety responsibilities continue during handover. Do not promise that every authorization can move by a private contract alone. Use the Japan market guide for the wider evidence program. Pure Global can support structure selection, responsibility mapping, dossier readiness and local coordination within the chosen route.
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Frequently asked questions
No. DMAH is a designated licensed role within the applicable foreign-holder structure, with domestic regulatory, quality and safety functions. A distribution contract alone does not create that arrangement.
No. The product still needs the applicable notification, certification or approval route, manufacturing/site and quality requirements, and compliant Japanese information. The appointment is one part of the program.
No. Assess the actual authorization structure and applicable regulatory procedures. Plan product/site records, quality and safety handover, labels and inventory rather than assuming all rights move automatically with a new agreement.
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