D-MAH gives you more independence in the Japanese medical device market

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In Japan, a manufacturer must have a local address and certified organization in order to be a Marketing Authorization Holder (MAH = license holder) for an approved medical device.

Common options for a foreign manufacturer are to 1) entrust a local distributor to hold your license, or 2) invest in local infrastructure to obtain your own certification with 3 mandatory staff positions: General Production and Marketing Manager (Soseki)*1, GVP Controller (Anseki)*2 and QA Controller (Hinseki)*3.

*1  Abbreviated Japanese term for “Sokatsu-Seizohanbai-Sekinin-Sha”

*2  Abbreviated Japanese term for “Anzen-Kanri-Sekinin-Sha”

*3  Abbreviated Japanese term for “Kokunai-Hinshitu-Gyomu-Un’ei-Sekinin-Sha”

A third option is to appoint a qualified local D-MAH (Designated Marketing Authorization Holder) to maintain your approval in your name. This solution enables foreign manufacturers to minimize initial investment and maintain control over all strategic options.

※“Marketing Authorization Holder (MAH)” is the license holder for which the regulatory approval of medical device is granted. Distribution of medical device will not be allowed in Japan without the MAH, who is comprehensively responsible for the quality of the device, logistics and post-marketing safety management.

※“Designated Marketing Authorization Holder (D-MAH)” is similar to an MAH, having overall responsibility for the quality of the approved medical device, logistics and post-marketing safety management. A D-MAH is not the approval holder, but a Japanese local presentative acting on behalf of the foreign manufacturer. 

The main roles of a D-MAH are:

  • Undertaking regulatory approval submission, obtaining other business permissions necessary for domestic distribution

  • Management of product importation, storage, inspection and logistics

  • Quality management in accordance with QMS Ordinance

  • Post-marketing safety management in accordance with GVP Ordinance

Vorpal's D-MAH Services

  • Supporting a wide range of medical devices including Classes II-IV, specially-controlled medical devices, specially-designated medical devices requiring maintenance and In-Vitro Diagnostics (IVD)

  • Highly skilled and experienced regulatory and clinical experts for submissions of new and improved, higher class devices  

  • Bilingual and bicultural background staff ensure clear and efficient communication

Third Party Logistics

Foreign

Manufacturer

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Sales

(Distributor)

PMDA/MHLW

RA/QA

Vorpal’s Roles & Responsibilities

Regulatory Actions:

•RA Services

•Data Gathering

•Field Services

•File Maintenance

•Japan Business Support

Logistics:

•Importation

•WH Management/Controlling

•Inspection & Market Releasing

•Transaction/Record keeping

•GVP monitoring & management

•Nonconformity Handling

•Return/Disposition Management

•others where necessary