{"id":12279,"date":"2026-05-14T14:43:50","date_gmt":"2026-05-14T05:43:50","guid":{"rendered":"https:\/\/microncro.com\/?post_type=solutions&p=12279"},"modified":"2026-06-10T20:51:51","modified_gmt":"2026-06-10T11:51:51","slug":"mah_dmah","status":"publish","type":"solutions","link":"https:\/\/microncro.com\/en\/solutions\/mah_dmah\/","title":{"rendered":"MAH\u30fbDMAH"},"content":{"rendered":"\n

MAH\u30fbDMAH<\/h2>\n\n\n\n

In Japan, a Marketing Authorization Holder (MAH) is required to place medical devices on the market and is legally responsible for regulatory submissions as well as post-market quality and safety management.<\/p>\n\n\n\n

As a licensed medical device MAH, Micron provides comprehensive, end-to-end support covering the entire lifecycle of medical devices\u2014from regulatory submissions to post-market quality and safety management.
We support both Marketing Authorization Holders (MAH) and Designated Marketing Authorization Holders (DMAH).<\/p>\n\n\n\n

Marketing Authorization Holder (MAH)<\/h3>\n\n\n\n

A Marketing Authorization Holder (MAH) is the legal entity responsible for placing medical devices on the Japanese market.
The MAH assumes full legal responsibility for the product, including regulatory approval, post-market safety management, and quality management.<\/p>\n\n\n\n

Designated Marketing Authorization Holder (DMAH)<\/h3>\n\n\n\n

A Designated Marketing Authorization Holder (DMAH) structure is used when an overseas company acts as the business owner.
In this arrangement, a designated MAH in Japan assumes the legal responsibility for regulatory approval and post-market activities on behalf of the overseas client.<\/p>\n\n\n\n

Regarding the System<\/h2>\n\n\n\n

MAH<\/h3>\n\n\n
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\"Organizational<\/figure>\n<\/div>\n\n\n

DMAH<\/h3>\n\n\n
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\"Regulatory<\/figure>\n<\/div>\n\n\n

Why Choose Micron<\/h2>\n\n\n\n
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One-stop support from system construction to regulatory affairs, minimizing time loss<\/figcaption><\/figure>\n\n\n\n
\"\"
A solid operational foundation covering Class II Medical Device Marketing Authorization, manufacturing, and sales\/lease business activities<\/figcaption><\/figure>\n\n\n\n
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A stable and reliable operational framework designed with post-approval operations in mind<\/figcaption><\/figure>\n<\/figure>\n\n\n\n

Micron’s Track Record<\/h2>\n\n\n\n
<\/th>Generic Device Name<\/th>Class<\/th>Manufacturer Country<\/th>Application Type<\/th>MAH\/DMAH<\/th><\/tr><\/thead>
1<\/td>General-purpose Diagnostic Imaging Workstation Software<\/td>Class\u2161<\/td>Belgium<\/td>Certification<\/td>MAH<\/td><\/tr>
2<\/td>General-purpose Diagnostic Imaging Workstation Software<\/td>Class\u2161<\/td>United States<\/td>Certification<\/td>DMAH<\/td><\/tr>
3<\/td>General-purpose Diagnostic Imaging Workstation Software<\/td>Class\u2161<\/td>United States<\/td>Approval<\/td>DMAH<\/td><\/tr>
4<\/td>General-purpose Diagnostic Imaging Workstation Software<\/td>Class\u2161<\/td>Japan<\/td>Certification<\/td>Our Product<\/td><\/tr>
5<\/td>MR Imaging Workstation Software<\/td>Class\u2161<\/td>Netherlands<\/td>Certification<\/td>DMAH<\/td><\/tr>
6<\/td>Ultrasound Imaging Workstation Software<\/td>Class\u2161<\/td>Netherlands<\/td>Certification<\/td>DMAH<\/td><\/tr>
7<\/td>X-ray Diagnostic Imaging Workstation Software<\/td>Class\u2161<\/td>South Korea<\/td>Certification<\/td>DMAH<\/td><\/tr>
8<\/td>MR Imaging Workstation Software<\/td>Class\u2161<\/td>South Korea<\/td>Certification<\/td>DMAH<\/td><\/tr>
9<\/td>Respiratory Gas Analyzer<\/td>Class\u2160<\/td>Singapore<\/td>Certification<\/td>MAH<\/td><\/tr>
10<\/td>Body Fat Measurement Device<\/td>Class\u2160<\/td>South Korea<\/td>Notification<\/td>MAH<\/td><\/tr>
11<\/td>X-ray Diagnostic Imaging Workstation Software<\/td>Class\u2161<\/td>Taiwan<\/td>Certification<\/td>DMAH<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\t
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Solutions<\/h2>\n\t\t\t\t