Global Regulatory Pulse

Focus on Japan Series: Part II – Understanding the Designated Marketing Authorization (D-MAH) Status for Foreign Device Manufacturers

In Consulting, Regulatory by Chikako Kitayama and Kei Yoshikawa

Over the last few weeks, NAMSA’s Japanese medical device development experts have been discussing a variety of regulatory topics related to Japan’s unique product development and manufacturing landscape. This series is intended to provide helpful information and best practices that lead to successful device operations in this quickly growing device marketplace.

Introduction to D-MAH

When conducting medical device manufacturing in Japan, it is essential to identify an entity that can serve as an organization’s Marketing Authorization Holder (MAH), or alternatively, a Designated Marketing Authorization Holder (D-MAH) if a product manufacturer will relinquish the establishment of a legal Japanese branch, allowing this entity to act as the company’s designated MAH. (Please reference our previous blog, ”Important Factors for Medical Device Development in Japan,” for further clarification of MAH/D-MAH designations, including potential benefits and disadvantages of both.)

Regulatory Process for Securing a D-MAH

In order to obtain a D-MAH, which is granted by the Minister of Health and Labor Welfare (MHLW), a medical device organization must follow the steps outlined in the Japanese regulatory pathway of “Exceptional Approval for Foreign Manufacturers.”

Specifically, a product manufacturer must identify a Japanese organization that currently holds a MAH to act as the government’s main contact, or D-MAH. The designated organization is required to conduct all safety measures within the Country of Japan on behalf of the foreign product manufacturer, and must maintain systems that comply with the Japanese Quality Management System (QMS) and Good Vigilance Practices (GVP).

In addition, the D-MAH is required to identify “three key administrators,” or “San-Yaku” in Japanese, a guideline set forth by the Ministerial Ordinances. (As referenced above, see our previous blog for further information.)

Pros and Cons of D-MAH

Although a D-MAH designation provides many benefits for foreign device manufacturers, this status is far more undesirable than that of an MAH. This is partially due to the fact that a D-MAH can easily be changed if a foreign authorization holder wishes to find another entity to serve as the new D-MAH. This has resulted in a scarce number of Japanese organizations that are willing to act as a D-MAH.

In such a situation, a notification of the D-MAH change must be submitted to the Pharmaceuticals and Medical Devices Agency (PMDA) by the newly identified D-MAH within a month after the change takes place. This process is managed through Japan’s “Exceptional Approval for Foreign Manufacturers” guidelines.

Finding a Trusted D-MAH Partner

Given the scarce number of Japanese organizations that wish to serve as a foreign manufacturer’s D-MAH, it can be a challenge to secure such a partnership. NAMSA, recognizing the need for device firms to have a trusted, reliable D-MAH entity, has wide-ranging experience in assisting Japanese medical device manufacturers in identifying the best-fit D-MAH partner. Please contact us at communications@namsa.com if you would like to discuss how to navigate the Japanese regulatory and medical device development landscapes, or visit our consulting page, here, for additional information.

The above is only a snapshot of important business factors for Japanese medical device manufacturers. For our next blog in the “Focus on Japan Series,” we will highlight how a medical device organization can obtain the required Foreign Manufacturing Accreditation (FMA) in Japan.

Authors:

Chikako Kitayama currently serves as Medical Research Manager for NAMSA-Japan.

Kei Yoshikawa serves as Medical Research Manager at NAMSA's Japan location.