Service
MDREX Japan supports every stage of entry into the Japanese market
We provide systematic support from strategic planning to licensing, insurance listing, distribution, and post-market management.

Services

DMAH
SERVICE 01

DMAH(Designated Marketing Authorization Holder)

Acting as the "official contact point" in the Japanese market, MDREX performs the functions of a Marketing Authorization Holder (MAH).
Enable product sales in Japan without establishing your own corporate entity.
Licenses & Registrations：Class I Medical Device Marketing Authorization Holder No.13B1X10468
License
SERVICE 02

Licensing and Authorization

Comprehensive support for preparing, translating, submitting, and negotiating PMDA application documents.
Achieve shorter approval timelines and higher success rates.
JGMP
SERVICE 03

Quality Management

We conduct a thorough gap analysis between Korean manufacturing sites and Japanese regulations.
We provide specific recommendations for necessary improvements and support compliance with JGMP.
Reimbursement
SERVICE 04

Insurance Listing

Expanding the market is possible through insurance coverage.
Evidence of cost-effectiveness and clinical utility is required.
Destribution
SERVICE 05

Distribution

We ensure a stable distribution network within Japan, and provide end-to-end support to secure sales channels.