MAH・DMAH

MAH・DMAH

In Japan, a Marketing Authorization Holder (MAH) is required to place medical devices on the market and is legally responsible for regulatory submissions as well as post-market quality and safety management.

As a licensed medical device MAH, Micron provides comprehensive, end-to-end support covering the entire lifecycle of medical devices—from regulatory submissions to post-market quality and safety management.
We support both Marketing Authorization Holders (MAH) and Designated Marketing Authorization Holders (DMAH).

Marketing Authorization Holder (MAH)

A Marketing Authorization Holder (MAH) is the legal entity responsible for placing medical devices on the Japanese market.
The MAH assumes full legal responsibility for the product, including regulatory approval, post-market safety management, and quality management.

Designated Marketing Authorization Holder (DMAH)

A Designated Marketing Authorization Holder (DMAH) structure is used when an overseas company acts as the business owner.
In this arrangement, a designated MAH in Japan assumes the legal responsibility for regulatory approval and post-market activities on behalf of the overseas client.

Regarding the System

MAH

DMAH

Why Choose Micron

Micron’s Track Record

	Generic Device Name	Class	Manufacturer Country	Application Type	MAH/DMAH
1	General-purpose Diagnostic Imaging Workstation Software	ClassⅡ	Belgium	Certification	MAH
2	General-purpose Diagnostic Imaging Workstation Software	ClassⅡ	United States	Certification	DMAH
3	General-purpose Diagnostic Imaging Workstation Software	ClassⅡ	United States	Approval	DMAH
4	General-purpose Diagnostic Imaging Workstation Software	ClassⅡ	Japan	Certification	Our Product
5	MR Imaging Workstation Software	ClassⅡ	Netherlands	Certification	DMAH
6	Ultrasound Imaging Workstation Software	ClassⅡ	Netherlands	Certification	DMAH
7	X-ray Diagnostic Imaging Workstation Software	ClassⅡ	South Korea	Certification	DMAH
8	MR Imaging Workstation Software	ClassⅡ	South Korea	Certification	DMAH
9	Respiratory Gas Analyzer	ClassⅠ	Singapore	Certification	MAH
10	Body Fat Measurement Device	ClassⅠ	South Korea	Notification	MAH
11	X-ray Diagnostic Imaging Workstation Software	ClassⅡ	Taiwan	Certification	DMAH