We support an introduction of Medical Devices into Japanese market
1.Regulatory Approval/Certificate
2.Reimbursement Authorization as
Service Fee or Material Fee.
3.Partnership with qualified *(D)MAH
*MAH stands for “Marketing Authorization Holder” which is an official license to
manufacture, import and/or sell medical devices in Japan.
MAH license is only available for Japanese entity, but overseas company can obtain
regulatory approvals under their name through designated MAH so called “DMAH”.
If you are interested in coming into the 2nd largest market, Japan with your new medical technology, we offer you the following services to make you successful.
Preliminary market surveillance including market size, competitor and so on.
Regulatory strategy how to
obtain the marketing authorization.
Authorization Holder: Your company via DMAH, or Distributor?
What would be the range of potential
reimbursement price
by National Health Insurance system.
What is the best approach to access
to the market.
Find candidate of distributor?
Establish your own subsidiary?
We offer flexible plan to set the strategic program and scope of service for you.
Initial market research, regulatory pathway, reimbursement strategy planning and recommendation of potential distributor.
Preliminary market research, organizing regulatory and reimbursement applications, finding distribution partner and pre-market sales activities.
Full scope service: preliminary market surveillance, obtaining regulatory approval, finding distributor and acting as your in-country representative including communication bridge with your distributor and monitor their activities.
Office Trois Forêt
Principle: Yoshio Mitsumori / 3-20-1 Minami-Azabu, Minato-ku, Tokyo 106-0047, Japan / Regus Azabu Green Terrace 5-553
Tel: +81-90-8478-3636 / Email: mitsumoriy@nifty.com
Since:2016 - Copyright Office Trois Foret
