D-MAH gives you more independence in the Japanese medical device market
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 representative 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
Vorpal’s Roles & Responsibilities
•Japan Business Support
•Inspection & Market Releasing
•GVP monitoring & management
•others where necessary