The Role of Designated Marketing Authorization Holders (DMAH) in Japan’s Medical Device Industry

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Japan’s medical device industry is renowned for its rigorous regulatory framework, ensuring the safety and efficacy of medical devices. A crucial aspect of this system is Japan’s Designated Marketing Authorization Holders (DMAHs). In this blog post, we will delve into the role of DMAHs in Japan’s medical device industry and highlight the significance of understanding their function for manufacturers and patients alike.

Overview of the Designated Marketing Authorization Holders System in Japan

The DMAH system plays a pivotal role in the medical device registration process in Japan, facilitating the approval and commercialization of medical devices. Under this system, DMAHs act as intermediaries between manufacturers and regulatory authorities, streamlining the regulatory process and ensuring compliance with relevant regulations. Compared to other regulatory frameworks, the DMAH system provides distinct advantages for manufacturers seeking to enter the Japanese market.

Primary Responsibilities of DMAHs

DMAHs have several responsibilities, including the following:

Marketing Authorization Process

The DMAHs shoulder the responsibility of submitting applications for medical device registration to the regulatory authorities in Japan. They collaborate closely with manufacturers to compile and organize the necessary documentation, ensuring compliance with stringent requirements. By serving as a liaison between manufacturers and regulatory agencies, DMAHs facilitate efficient communication and expedite the approval process.

Post-Market Surveillance and Vigilance

They play a critical role in monitoring the safety and performance of medical devices after they have been approved for marketing. They proactively collect and assess information on adverse events and product performance, promptly reporting any concerns to the regulatory authorities. This vigilance enables swift actions to be taken, ensuring the continued safety and effectiveness of medical devices in the Japanese market.

Regulatory Compliance and Quality Management

Another key responsibility of DMAHs is to ensure regulatory compliance and maintain robust quality management systems. They assist manufacturers in adhering to complex regulatory requirements, overseeing activities such as labeling, packaging, and manufacturing processes. DMAHs work closely with manufacturers to implement quality management systems, ensuring ongoing compliance with Japanese regulations.

Advantages of the DMAH System for the Medical Device Industry

For medical device manufacturers, the DMAH system provides numerous benefits. Some of the most significant advantages include:

  • Improved Market Access for Manufacturers – It offers a streamlined pathway for manufacturers to enter the Japanese market. By leveraging the expertise and knowledge of DMAHs, manufacturers can navigate the complex regulatory landscape more effectively. This facilitates market access, providing opportunities for innovation and growth in the medical device industry.
  • Streamlined Regulatory Processes – Collaborating with DMAHs simplifies the regulatory processes associated with medical device approval in Japan. DMAHs possess in-depth knowledge of the regulatory requirements, enabling them to guide manufacturers through the intricacies of the system. Their involvement expedites the approval process, reducing time-to-market for medical devices.
  • Enhanced Patient Safety and Product Quality – The DMAH system prioritizes patient safety and product quality. DMAHs actively engage in post-market surveillance activities, promptly reporting any adverse events or product issues. By ensuring compliance with regulatory standards and implementing quality management systems, DMAHs contribute to the overall safety and effectiveness of medical devices in Japan.

Entities Eligible to Serve as DMAHs

These entities are eligible to serve as DMAHs:

  • Domestic Manufacturers as DMAHs – Domestic manufacturers in Japan can take on the role of DMAHs for their own products. This option provides manufacturers with a deeper understanding of their products and allows for greater control over the regulatory processes. However, manufacturers must meet specific qualifications and fulfill requirements set by the regulatory authorities.
  • Importers as DMAHs – Importers also have the opportunity to act as DMAHs for medical devices they bring into Japan. Importers play a crucial role in ensuring the compliance and safety of imported medical devices. They must fulfill eligibility criteria and take on the responsibility of registering the devices and overseeing regulatory compliance on behalf of the manufacturers.
  • Third-Party Organizations as DMAHs – In addition to manufacturers and importers, third-party organizations can serve as DMAHs in Japan. These organizations specialize in regulatory affairs and have expertise in navigating the Japanese medical device approval process. Choosing a third-party DMAH allows manufacturers to leverage the knowledge and experience of regulatory professionals, easing the burden of regulatory compliance.

If you register via a third-party DMAH, the registrations will be in your name, intellectual property will be protected, and you can change distributors more easily.

Effective Collaboration with DMAHs

Conducting Thorough Research and Due Diligence

Before selecting a DMAH, it is crucial for manufacturers to conduct thorough research and due diligence. Understanding the reputation, experience, and track record of potential DMAHs is essential. Manufacturers should consider factors such as their expertise, resources, and ability to provide effective support throughout the regulatory journey.

Consulting with Regulatory Experts

Navigating the Japanese medical device registration process can be complex, and manufacturers should seek guidance from regulatory experts. DMAHs who have professionals who are well-versed in Japanese regulations and have experience working with the PMDA or Japanese notified bodies can provide valuable insights and ensure a smoother and more efficient process.

Understanding the Obligations of DMAHs

Manufacturers should have a clear understanding of the obligations and responsibilities of DMAHs. This includes knowing the scope of their involvement in the marketing authorization process, post-market surveillance activities, and regulatory compliance. Open and transparent communication with the DMAH is crucial to establish a strong working relationship and ensuring regulatory compliance.

Establishing Clear Communication Channels

Maintaining clear communication channels with the DMAH is essential for a successful collaboration. Regular updates, prompt sharing of information, and addressing any concerns or questions in a timely manner will help foster a productive relationship. Effective communication ensures that manufacturers and DMAHs are aligned throughout the approval and post-market phases.

Ensuring Regulatory Compliance

Preparing Comprehensive Documentation

Manufacturers must diligently prepare and submit comprehensive documentation for medical device registration. This includes technical documentation, clinical data, labeling, and instructions for use. Working closely with the DMAH, manufacturers can ensure that the documentation meets the stringent requirements of the regulatory authorities in Japan.

Adhering to Labeling and Packaging Requirements

Accurate and compliant labeling and packaging are essential for medical devices marketed in Japan. Manufacturers should collaborate with their DMAH to ensure that the labeling and packaging meet the specific regulatory guidelines, including language requirements, safety symbols, and product identification information.

Conducting Post-Market Surveillance Activities

Post-market surveillance is a critical aspect of regulatory compliance in Japan. Manufacturers, in collaboration with the DMAH, should establish mechanisms to monitor the safety and performance of their medical devices in the market. This includes collecting data on adverse events, conducting investigations when necessary, and promptly reporting any concerns to the regulatory authorities.

Regular Audits and Quality Control Measures

Maintaining ongoing compliance requires regular audits and quality control measures. Manufacturers, with the support of the DMAH, should implement robust quality management systems to ensure that their manufacturing processes, distribution channels, and post-market activities align with regulatory requirements. This includes periodic internal audits, continuous improvement initiatives, and adherence to good manufacturing practices.

Designated Marketing Authorization Holders (DMAHs) play a pivotal role in Japan’s medical device industry, facilitating the regulatory approval and post-market surveillance of medical devices. By understanding the responsibilities and advantages of working with DMAHs, manufacturers can navigate the complex landscape of medical device registration in Japan more effectively. Thorough research, consultation with regulatory experts, and a collaborative approach with DMAHs are crucial to ensuring regulatory compliance and successfully bringing medical devices to the Japanese market. By prioritizing patient safety, product quality, and compliance, manufacturers can contribute to the advancement of healthcare in Japan.

Tran Doan – Director, Pacific Bridge Medical (PBM)
Ms. Doan leads Asian market research, regulatory, and consulting projects at PBM. She graduated with a B.A., Phi Beta Kappa, in Mathematics and Economics from Franklin and Marshall College.

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