Expanding into the Japanese medical device market requires a clear understanding and adherence to PMDA regulatory requirements, including the roles of Marketing Authorization Holder (MAH) and Designated Marketing Authorization Holder (DMAH). These roles are crucial for ensuring compliance with Japan's Pharmaceuticals and Medical Devices Act (PMD Act) and and for facilitating the smooth entry of medical devices into the Japanese market.
PMDA, Medical Devices and Marketing Authorization Holder (MAH) in Japan
The Marketing Authorization Holder (MAH) is a pivotal role in Japan's medical device regulatory framework. This role is equivalent to and has replaced the previous PMDA system known as the In-Country Caretaker (ICC) system. The Marketing Authorization Holder (MAH) is responsible for managing the regulatory approval process for medical devices.
PMDA, Foreign Manufacturers and Marketing Authorization Holder (MAH) in Japan
According to the PMDA, foreign manufacturers must appoint a local representative to register their medical devices in Japan. Domestic manufacturers can directly register their devices with the PMDA and act as their own Marketing Authorization Holder (MAH). In contrast, foreign manufacturers cannot register their medical devices directly. The PMD Act requires them to designate a local entity or individual in Japan to serve as their representative. Foreign manufacturers have the option to either appoint a MAH or a DMAH for their medical devices
Understanding the MAH, DMAH and FRAH for Medical Devices in Japan
Marketing Authorization Holder (MAH) : The Marketing Authorization Holder (MAH) is an individual or entity that holds the marketing license for a product. The MAH is responsible for overseeing and managing the manufacturer, ensuring compliance with Quality Management Systems (QMS) across all manufacturing sites, and ensuring proper product release into the market.
Foreign Restrictive Authorization Holder (FRAH) : The Foreign Restrictive Authorization Holder (FRAH) is a foreign manufacturer that holds marketing approvals for medical devices in Japan. The marketing authorization would be on FRAHs name but the domestic quality control responsibiliies lie with the DMAH. The FRAH may designate a licensed DMAH in Japan.
Designated Marketing Authorization Holder (DMAH) : If a foreign manufacturer prefers not to transfer full ownership of their product, they can appoint a DMAH to act on their behalf in Japan.The Designated MAH (DMAH), known as “Sennin Seihan” in Japanese, is an MAH appointed by the FRAH to perform required quality control duties within Japan. The DMAH is responsible for implementing measures to prevent public health and hygiene hazards in Japan that may arise from the product.
PMDA Requirements for an MAH and DMAH
The MAH or the DMAH must be based in Japan.
The MAH or / and the DMAH must maintain agreements with the manufacturer to ensure compliance. The agreement shall detail the products in scope and define the roles and responsibilities of each party.
The entities are subjected to QMS inspections
Responsibilities of MAH and / or DMAH in Japan
The MAH and DMAH role is essential for ensuring that medical devices comply with Japanese regulations and standards.
Regulatory Submissions: The MAH / DMAH is responsible for submitting necessary applications and documentation to the Pharmaceutical and Medical Device Agency (PMDA) or the relevant certification body. This includes ensuring that all regulatory requirements are met before a device can be marketed.
Compliance Management: The MAH / DMAH must ensure that the device adheres to Japanese regulations, including the Quality Management System (QMS) requirements. This involves regular inspections and compliance checks across all manufacturing sites.
Regulatory Liaison: The MAH / DMAH acts as the primary contact point between the foreign manufacturer and Japanese regulatory authorities. They facilitate communication and ensure that all regulatory requirements are met.
Document Management: The DMAH ensures that all regulatory documents and submissions are accurately prepared, translated into Japanese, and submitted to the relevant authorities.
Local Representation: They manage local compliance, including handling inspections and audits. They are responsible for taking necessary measures to prevent hazards to public health and hygiene caused by the product.
Post-Market Surveillance: After the device is on the market, the MAH is tasked with monitoring its performance and safety. This includes reporting any adverse events or issues to the PMDA and taking appropriate corrective actions.
Role of MAH and Designated Market Authorization Holder (DMAH) in Medical Device Registration in Japan
Appointment: Foreign manufacturers must appoint a DMAH before starting the registration process. Domestic manufacturers can appoint an MAH if needed.
Submission: The appointed MAH or DMAH submits required documentation to PMDA or relevant certification bodies.
Compliance: Ensure adherence to all regulatory requirements, including QMS and clinical data if applicable.
Post-Market Activities: Manage ongoing compliance, including adverse event reporting and product recalls if necessary.
Considerations for Choosing Between an Independent Entity and a Distributor as MAH or DMAH:
Control: An independent DMAH provides more control over the device approval process and distributor selection.
Flexibility: It allows flexibility in changing distributors without re-registering the device.
Confidentiality: DMAHs can handle proprietary design information confidentially.
Expertise: DMAHs are typically more experienced in regulatory responsibilities compared to distributors.Understanding and managing the roles of MAH and DMAH are crucial for successful device registration and marketing in Japan.
Artixio: Your Partner in Navigating Japanese Medical Device Regulations
By partnering with experienced regulatory professionals, manufacturers can efficiently navigate the complexities of Japanese regulations.Artixio offers comprehensive regulatory support for medical devices in Japan. Our experienced team can assist with MAH and DMAH services, ensuring a smooth and compliant entry into the Japanese market.
For more information on how we can support your regulatory needs, contact us at info@artixio.com.
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