Marketing Authorization Holder for Medical Device Registration in Japan

Your Path to Market Entry Excellence in Japan Starts with Freyr!

Medical device manufacturers without a presence in Japan must appoint a Market Authorization Holder (MAH)/Designated Marketing Authorization Holder (DMAH) to enter the Japanese market. Freyr can act as your DMAH, aiding you in ensuring compliance and facilitating a seamless market entry.

Medical Device Registration in Japan Overview

Foreign manufacturers should appoint a Market Authorization Holder (MAH)/Japan Designated Market Authorization Holder (DMAH) agent as a pre-requisite for medical device approvals in Japan. PMDA also allows the appointment of a DMAH. In the former case, MAH owns and controls the registration and certificate/approval of the product. In the latter case, a foreign manufacturer owns and controls the registration and certificate/approval of the product, and DMAH acts as a representative in Japan. It is ideal to appoint a DMAH rather than an MAH, as the process to change a DMAH is easier than changing the MAH.

Freyr MAH/DMAH Competencies:

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    Local Agent Representation in Japan
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    Liaison with the PMDA
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    Preparation of Documentation as per the PMDA Standards
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    Post-market Surveillance Activities
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    Translation Support
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    License Renewal
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    Regulatory Advisor
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    End-to-end Registration Support

Frequently Asked Questions (FAQs)

An MAH is an entity that has obtained a marketing license for medical devices in Japan and is responsible for supervising and managing the manufacturer, ensuring compliance with Quality Management System (QMS) requirements, and proper product release to the market.

In Japan, the role of the Marketing Authorization Holder (MAH) is to obtain the marketing license for medical devices or IVDs. The Japan MAH is responsible for supervising and managing the manufacturer, ensuring compliance with the Quality Management System (QMS) of all manufacturing sites, and ensuring the proper release of the product to the market. The MAH must be based in Japan and is accountable for conducting required quality control duties and taking necessary measures to prevent hazards to public health and hygiene in Japan caused by the product.

In Japan an MAH must be based in Japan to obtain marketing approval for medical devices. A foreign manufacturer who has obtained marketing approvals for medical devices in a foreign country can designate a licensed MAH in Japan to market the product. This Designated MAH (DMAH), also known as "Sennin Seihan" in Japanese, will be responsible for supervising and managing the manufacturer, ensuring compliance with the Quality Management System (QMS) of all manufacturing sites, and ensuring proper product release to the market. The foreign manufacturer is referred to as a Foreign Restrictive Authorization Holder (FRAH), and they must ensure that the DMAH takes necessary measures for the prevention of hazards to public health and hygiene in Japan caused by the product.

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Why Freyr?

  • Independent Representation and Regulatory Support.
  • Continuous Liaison with the Agency for Submissions, Queries, and Feedback.
  • Single Point of Contact in the Country for Liaison with the Regulatory Agency.