Foreign manufacturers with no local presence in Japan must appoint a Marketing Authorization Holder (MAH) or a designated MAH (dMAH) to manage their device registrations and liaise with the Pharmaceuticals and Medical Devices Agency (PMDA).
Both MAH and dMAH must be based in Japan and have an appropriate Marketing Authorization Holder license, according to the Pharmaceutical Affairs Law (PAL).
The MAH/dMAH will maintain the medical device approvals and handle any registration processes. When a medical device is approved and is marketed in Japan, the MAH/dMAH will act as the representative for that device in Japan.
The missions and duties of MAH and dMAH are similar. Both have responsibilities in Good Quality Practice (GQP) and Good Vigilance Practice (GVP). However, there are some differences:
- The MAH controls registration of the medical device. The MAH is the applicant and becomes the owner of the approval/certification.
- When the submission of a supplement application or a transfer application of the approval/certification is required, the MAH can submit such an application under their own purview. There is no requirement of getting a signature by a foreign manufacturer since the MAH is the owner of the approval.
- The foreign manufacturer controls registration of the medical device. The foreign manufacturer is the applicant and becomes the owner of the approval/certification.
- Since the foreign manufacturer cannot obtain the license as a MAH, the foreign manufacturer must appoint a Japanese company, who has an appropriate MAH license, as their dMAH.
- The dMAH acts as representative for the foreign manufacture during and after product registration.
- The application for registration requires signature by the foreign manufacture and is submitted through the dMAH.
- When a supplement application or transfer of approval is submitted, signature by the representative person of the foreign manufacturer is required although the application is submitted through the dMAH.
- If the foreign manufacturer wants to change their dMAH, it is an easier process compared to changing their MAH.
Pacific Bridge Medical can act as your dMAH in Japan.