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Market Overview

Entering the Japanese medical device market can lead to substantial growth and revenue opportunities. Japan is the third-largest medical device market in the world and is poised for even greater  growth — forecast to increase by USD 15.56 billion, at a CAGR of 6.75% between 2024 and 2028. As a technologically advanced nation with an aging population, it places significant value on healthcare innovation.

For foreign medical device manufacturers and startups, navigating the regulatory landscape in Japan can be a complex and overwhelming process. The country’s strict constraints for medical device registration call for meticulous adherence to their guidelines. Because approval involves extensive documentation and rigorous quality control measures, having a knowledgeable partner is crucial for success. Appointing an experienced Designated Marketing Authorization Holder (DMAH) is an essential part of ensuring compliance with Japan’s medical device regulations.

JAPAN MEDICAL DEVICE MARKET INSIGHTS TO 2032

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(Source: Spherical Insights) 

  • The Japan Medical Device Market size was valued at $43.86B in 2022. 
  • The market is growing at a CAGR of 7.95% from 2022 to 2032. 
  • The Japan Medical Device Market size is expected to reach $94.23B by 2032. 

 

MEDICAL DEVICE REVENUE IN JAPAN 2018-2028, BY SEGMENT

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Source: Published by Statista Research Department, Feb 9, 2024

  • Revenue is forecast to significantly increase in all medical device segments.  
  • The market's largest segment is cardiovascular devices with a projected market volume of $5.2B in 2024. 
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Designated Marketing Authorization Holder (DMAH)


DMAH Enables More Independence in the Japanese Medical Device Market


Only a local entity qualified as a Marketing Authorization Holder (MAH), or a Designated Marketing Authorization Holder (DMAH) may import and sell medical products to the Japanese market. All foreign medical device and pharmaceutical companies selling in Japan must assign a MAH or DMAH to manage their product registrations and work with Japan’s regulatory authorities.
 

LEARN MORE ABOUT DMAH

 

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WHAT IS DMAH?

DMAH In-Country Representation enables foreign manufacturers to leverage MCRA’s domestic infrastructure and personnel to minimize initial investment and maintain control over all strategic operations. The DMAH acts as the representative for the foreign manufacturer during and after product registration.

MAIN ROLES OF DMAH: 

  • Undertaking regulatory approval submission, obtaining other permissions such as Foreign Manufacturer Registration to pursue Japan market entry
  • Management of product importation, storage, inspection and logistics
  • Maintenance of regulatory approval by change control 
  • Quality management in accordance with QMS Ordinance 
  • Post-marketing safety management in accordance with GVP Ordinance 

BENEFITS OF MCRA JAPAN’S DMAH SERVICES

  • Supporting a wide range of medical devices (Class II and above)
  • Skilled regulatory and clinical experts for submissions of new and improved, higher-class devices 
  • Talented support staff with bilingual and bicultural backgrounds for clear and efficient communication
Learn more about dmah

There are three pathways for foreign manufacturers to meet Japan in-country requirements for medical device commercialization.  
 

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