MDREX JAPAN - Medical Device, Digital Health, Consulting Group

SERVICE

Solutions Provided by MDREX

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.

SERVICE 02

Licensing and Authorization

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

SERVICE 03

Quality Management

We conduct a thorough analysis of the gaps between Korean manufacturing sites and Japanese regulations.
Provide concrete recommendations for necessary improvements and support compliance with JGMP.

SERVICE 04

Insurance Listing

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

SERVICE 05

Distribution

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

List of Services

ABOUT

Leveraging a strong network with our Korean headquarters and expert knowledge in Japan, we support a one-stop solution for Korean medical devices entering the Japanese market.

Reasons to Choose MDREX Through close collaboration between our Korean headquarters and Japanese office, a team of experts well-versed in both countries provides comprehensive support across regulations, quality, insurance, and distribution.
We are a reliable partner specializing in the medical device sector, providing continuous support from initial consultation to market expansion.

About MDREX

MDREX supports the entry of Korean medical devices into the Japanese market!

SERVICE

ABOUT