DMAH: Empowering Medical Device and In-Vitro Diagnostics (IVD) Companies in Japanese Market Access 

Kyrie Mattos

 June 2, 2023

The Japanese medical device and IVD market, the third largest globally, possesses unique complexities that device companies need to navigate. This is where the Drug Market Authorization Holder (DMAH) in Japan plays a pivotal role. The Japan DMAH is an entity integral to the process of introducing new medical devices and IVDs into the Japanese market, managing a multitude of critical responsibilities.

Understanding the Role of the DMAH in Japan

The Core Functions and Responsibilities

Primarily, the Japanese Designated Marketing Authorization Holder operates as an intermediary between foreign device companies and the Pharmaceuticals and Medical Devices Agency (PMDA). They effectively communicate the relevant information regarding new device applications and ongoing approvals. Further, the DMAH in Japan manages the critical process of device and IVD approval.

This role encompasses coordinating pre-clinical studies, clinical trials, regulatory reviews, and post-marketing surveillance – all stages intrinsic to the lifecycle of a device product. Moreover, the DMAH ensures adherence to Japan’s stringent regulations. They maintain a comprehensive understanding of these rules, diligently monitoring updates and changes to ensure compliance. They are also responsible for facilitating market access, often navigating intricate regulatory procedures.

Navigating the Unique Japanese Market

Understanding and adapting to the distinct regulatory environment of Japan is a task of paramount importance. A proficient DMAH expedites the approval process by leveraging its intricate knowledge of the Japanese regulatory framework. Their expertise translates into a smoother, faster route to market access, an essential advantage for device and IVD companies looking to make an impact in Japan.

The Device and IVD Approval Process in Japan

Pre-clinical Studies

The pre-clinical studies phase is a crucial step in the device and IVD approval process, assessing the safety and effectiveness of potential products. The DMAH may take on a vital role in coordinating and overseeing these studies, ensuring adherence to Japanese guidelines and regulations. Their expertise in designing study protocols, analyzing results, and preparing comprehensive reports for PMDA review is instrumental in supporting the smooth progression of the device development process.

Clinical Trials

Following successful pre-clinical studies, the device advances to the clinical trials phase, involving human subjects. The DMAH takes charge of ensuring compliance with Japanese regulations and ethical standards.

Regulatory Review

The regulatory review stage is a pivotal point in the device approval process, where the DMAH’s expertise shines. They meticulously compile the comprehensive application for the PMDA, including all essential data, results, and supporting documentation. Their in-depth understanding of Japanese regulatory requirements and their attention to detail significantly reduce the risk of application rejection due to incomplete or inaccurate data. The DMAH’s role in preparing a well-structured and comprehensive application strengthens the chances of a successful review and paves the way for the potential device or IVD approval in Japan.

Post-marketing Surveillance

Once a device or IVD is approved and enters the market, the responsibility of the Designated Marketing Authorization Holder in Japan doesn’t end. They conduct post-marketing surveillance to monitor the

device’s safety and effectiveness in a larger population. This continuous monitoring helps in identifying any potential issues that may develop.

The Value of a Competent DMAH in Japan

A proficient DMAH can significantly enhance a device or IVD company’s prospects in Japan. Whether a company aims to introduce an innovative device or launch an established product into the Japanese market, the DMAH’s expertise can provide critical advantages. Facilitating a smooth device approval process and ensuring regulatory compliance, a competent DMAH aids in accelerating the time it takes for a device to reach the market. Their experience in navigating Japan’s unique device and IVD landscape can streamline the device launch process, leading to cost savings and better market positioning.

Emerging Trends in the Japanese Device and IVD Sector

In the rapidly evolving Japanese device sector, staying ahead of industry trends is paramount. DMAHs, as knowledgeable regulatory partners, are at the forefront of these changes. They closely monitor shifting regulatory policies, keeping device companies informed and helping them adapt their strategies accordingly. Staying abreast of advancements in device manufacturing technology, DMAHs assist in implementing innovative approaches to meet evolving quality standards and manufacturing processes.

Moreover, the increasing emphasis on post-marketing safety measures requires a proactive approach from DMAHs. They play a vital role in supporting the device’s efforts, ensuring timely reporting of adverse events, and facilitating effective risk management strategies. In guiding device companies through these safety measures, DMAHs help maintain product safety and compliance, bolstering the confidence of regulatory authorities and healthcare professionals.

Through their expertise and comprehensive understanding of the Japanese medical device landscape, DMAHs enable medical device companies to navigate the complexities of the industry successfully. By aligning regulatory strategies, manufacturing practices, and safety measures with the changing landscape, DMAHs contribute to the continued competitiveness and success of their device and IVD products in the ever-evolving Japanese market.

Embracing the Unique Characteristics of the Japanese Market

Entering the Japanese market demands a strategic and comprehensive understanding of its unique needs and preferences. International companies must not only comply with local regulations but also consider potential collaborations with local entities or influencers to enhance market acceptance.

The Designated Marketing Authorization Holder in Japan can serve as a guide in this regard, supporting device and IVD companies in navigating legal and regulatory hurdles while identifying potential partnership opportunities. A strategic approach, coupled with the expertise of a competent DMAH, can significantly ease the path toward successful market penetration in Japan’s bustling medical device and IVD sector.

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