Establish Business in Japan
Points to Note for Overseas Companies Looking to Establish Business in Japan
Overseas medical device manufacturers have three options to market their medical devices in Japan as described below.
(1) A Japanese company with a MAH license becomes the approval holder
(i.e., the approval applicant).
The overseas manufacturer enters a distribution agreement with a MAH-licensed company in Japan.
The MAH company submits applications for regulatory approval (certification). After obtaining such approval (certification), only the MAH company can import and distribute the medical devices, acting as an exclusive import agent (see Fig. 1 for Case 1).
(2) The foreign manufacturer becomes the approval holder.
Foreign manufacturers can become approval holders, although MAH licenses apply only to Japanese companies.
A foreign manufacturer planning to submit its own application for approval must assign a Japanese company with appropriate MAH licensing as a DMAH to act as its representative, as shown in Fig. 2 for Case 2.
(3) A subsidiary is established in Japan and obtains a MAH license
(i.e., the subsidiary in Japan becomes the approval holder).
This is the simplest way.
Foreign manufacturers establish their own subsidiaries in Japan; the subsidiary obtains a MAH license and acts as a MAH, as in Case 1.
In this case, the subsidiary (i.e., the MAH) becomes the approval holder.
In order to establish a subsidiary with a MAH license in Japan, appropriate offices and qualified personnel are required.
The actual requirements for MAH licensing depend on the classification (Class 1, 2 or 3 MAH licenses).
*Differences between Case 1 and Case 2 above
A Japanese company with a MAH license becomes the approval holder.
Accordingly, applications (including those for partial changes) should be submitted as the responsibility of the MAH company.
The MAH company must manage approvals, GQP (Good Quality Practice) and GVP (Good Vigilance Practice).
The MAH company has the right to transfer approval to other companies with MAH licenses.
The foreign manufacturer becomes the approval holder, and a Japanese company with a MAH license acts as a representative in Japan (i.e., a DMAH).
Applications (including partial change applications) should be submitted as the responsibility of the foreign manufacturer.
The DMAH company must manage GQP (Good Quality Practice) and GVP (Good Vigilance Practice).
The overseas company has the right to change from the DMAH company to another company with an MAH license.