DMAH Services
Role of a Marketing Authorization Holder(MAH)
The applicant of submissions for medical device approvals/certifications must have an appropriate business license; Marketing Approval Holder (MAH), according to the Japanese Pharmaceutical Affairs Law. Since only companies registered in Japan can obtain the MAH license, overseas manufacturers must appoint a Japanese company who has the license, as the MAH. Then, the MAH will maintain the medical device approval and registration process. When the medical device is approved and is marketed in Japan, the MAH will act as the representative organization in Japan, and the MAH must have responsibilities of GVP and GQP.
There are two ways to appoint MAH for overseas manufacturers; MAH or DMAH.
What are differences among DMAH and MAH?
MAH: Marketing Authorizationt Holder
- The MAH company controls registration of the medical device. The MAH is the applicant and becomes owner of the approval/certification.
- When a supplement application or transfer application of the approval is submitted, the MAH can submit the application under their responsibilities. There is no requirement of signature by overseas manufacturer, since the MAH is the owner of the approval.
DMAH: Designated Marketing Authorization Holder
- The overseas manufacturer controls registration of the medical device. The overseas manufacturer is the applicant and becomes owner of the approval/certification.
- Since overseas manufacturers cannot obtain the license of MAH, the manufacturer must appoint a Japanese company who has an appropriate MAH license, as the DMAH.
- The DMAH act as representative for the overseas manufacture during and after product registration.
- The application for registration requires signature by the overseas manufacture and is submitted through the DMAH.
- When a supplement application or transfer application of the approval is submitted, signature by the representative person of the overseas manufacturer is required. Then, the application is submitted through the DMAH.
- If the overseas manufacturer wants to change the DMAH company, it’s easier to change compared to the case in MAH.
Rolls/tasks of MAH and DMAH are almost same, such as responsibilities of GVP and GQP. But there are some differences among MAH and DMAH as mentioned in above. Therefore, it should be determined carefully, considering environment and situation of your company and your business partner (ie; subsidiary in Japan, reliability and possibility of your partner in Japan etc.)
Japan MDC is licensed as a Medical Device Marketing Authorization Holder (1st-class MAH), and provides consultation services related to the acquisition of the above licenses for companies registered in Japan.
As such, we can also work as a professional, independent DMAH for your company in Japan.
If you are thinking a distribution in Japan, we would recommend our DMAH Service as one option.
Don't hesitate to contact us concerning any questions which may arise.
Japan MDC's DMAH Service Flow
