Japan DMAH Practice QA

Collaborating with our colleagues in Tokyo, Japan and Taiwan, we are here to serve you:
Arranging a designated Marketing Authorization Holder (DMAH) in Japan.
Assisting with foreign manufacturer registration (FMR) in Japan.
Conducting audits for quality management systems (MHLW MO169).
Supporting the pre-market registration/certification/approval process (marketing approval).

Email: tyo4ww@evershinecpa.com
Contact : Andrea Kyu, speak both Japanese and Mandarin
Onarimon Yusen Building 7F,Nishi-Shinbashi 3-23-5,Minato-ku, Tokyo 105-0003, Japan

How to market medical devices in Japan? What are the regulatory requirements and pathways for medical devices in Japan (Japan’s PMD Act)?

The regulatory framework for the application of medical devices in Japan is primarily governed by the “Pharmaceuticals and Medical Devices Act” (PMD Act), which came into effect on November 25, 2014, replacing the previous “Japanese Pharmaceutical Affairs Law” (JPAL).

The PMD Act is formulated by the Ministry of Health, Labour and Welfare (MHLW) of Japan and implemented by the Pharmaceuticals and Medical Devices Agency (PMDA). This regulation covers pre-market application/certification/approval, manufacturer registration, Designated Marketing Authorization Holder (DMAH), quality management system, post-market surveillance, and other aspects related to medical devices, in vitro diagnostic reagents, pharmaceuticals, cosmetics, regenerative/cellular/gene therapy products, and more, to ensure the safety of the Japanese population.

If you intend to market medical devices in Japan, you need to follow the following procedures:

• You need to designate a DMAH located within Japan to act as your legal representative in Japan. The DMAH must hold the appropriate licenses and be responsible for communication with Japanese authorities, submission of application documents, implementation of the quality management system, handling post-market notifications, and other related matters.
• You need to register your manufacturing facility with the PMDA and provide relevant information such as design development, production or sterilization processes, and operating principles.
• You need to choose the appropriate pre-market review pathway based on the classification of your product. Medical devices in Japan are classified into four categories: Class I (low-risk), Class II (medium-risk), Class III (high-risk), and Class IV (highest risk). Different levels of clinical data and technical documentation are required for products of different classes, and they are reviewed by different regulatory bodies. Generally, Class I and some Class II products can undergo self-certification or be reviewed by third-party certification bodies (RCBs), while Class III and some Class II products require review by the PMDA or RCB.
• You need to comply with Japan’s quality management system requirements, specifically the MHLW Ordinance No. 169. This ordinance stipulates that manufacturers and DMAHs must establish and implement a quality management system based on ISO 13485 and Good Manufacturing Practice (GMP) principles and undergo audits by the PMDA or RCB.
• You need to conduct post-market surveillance, which includes collecting and reporting adverse events, implementing post-market changes, and complying with post-market surveillance requirements (Surveillance).

These steps are essential to navigate the regulatory landscape and market medical devices in Japan while ensuring compliance with the PMD Act and related regulations.

Why need to choose DMAH In Japan when you selling Medical Devices into Japan?

Regardless of the classification level, a Japanese representative must be designated, and there are two types: Marketing Authorization Holder (MAH), known as “Seihan” in Japanese, and Designated Marketing Authorization Holder (DMAH), known as “Sennin seihan” in Japanese.

DMAH serves as the representative of overseas manufacturers within Japan, similar to an Authorized Representative (AR) in the European Union. All applications for marketing authorization, post-marketing surveillance, and reporting are carried out through the DMAH. (Note that IVD, drug, and medical device DMAHs have different licenses.)

While Japanese overseas manufacturers are required to designate a DMAH for product marketing applications, manufacturers can utilize the Foreign Exceptional Approval System to register the product under their own name, becoming a Foreign Restrictive Authorization Holder (FRAH) instead of a DMAH.

DMAH is designated by overseas manufacturers that have obtained product marketing authorization to appoint a Japanese MAH as their DMAH within Japan. The overseas manufacturer acts as the applicant for pre-market certification/approval and is the holder of the product marketing authorization.

DMAH is authorized by the overseas manufacturer to carry out relevant operations during or after the application for marketing certification/approval.

Authorization from the overseas manufacturer is required for DMAH to transfer the product marketing authorization.

What is Foreign Manufacturer Registration (FMR) application in Japan?Procedures and required documents?

Foreign Manufacturer Registration (FMR) is part of the Pre-Market Submission (PMS) process.

Initially, it was believed that a Quality Management System (QMS) audit should precede FMR. However, according to the QMS regulation in Japan (PMDA, 2015), it states: “Manufacturer needs ‘Registration’ before the QMS inspection is conducted.”

Therefore, FMR can be likened to factory registration in Taiwan. Regardless of the classification level, all foreign medical device manufacturers responsible for design development, production, and final assembly locations must submit Form 63-5 through DMAH to MHLW to apply for Foreign Manufacturer Registration (FMR) and become an Accredited Foreign Manufacturer. This process is referred to as “Gaikoku seizo-gyosya nintei” in Japanese.

The FMR certificate is valid for 5 years, and MHLW recommends starting the renewal process 5 months before the expiration date.

Regarding the Quality Management System (MHLW MO169) audit:

The MHLW MO169 audit is part of the Pre-Market Certification (PMC) process. FMR must be completed before conducting the Quality Management System audit. All medical device manufacturers, regardless of classification level, must adhere to MHLW MO169 (Ordinance #169), which is based on ISO 13485. On March 26, 2021, MO169 was revised to harmonize with ISO 13485:2016, with a transition period of 3 years. Therefore, DMAH must comply with this version of MO169 by March 25, 2024, at the latest. (For version differences, please refer to PMDA’s “Revision of Japanese Medical Device QMS requirements.”)

Chapter 3 of MO169 includes additional requirements for QMS documentation/record retention, adverse event reporting, Good Vigilance Practice (GVP), and more, specifically for (D)MAH. (For details, please refer to PMDA’s “Tentative translation of MHLW MO 169 Chapter 3, as revised in 2021.”)

Most Class II medical devices (Specified Controlled) have their QMS audited by RCB, while some Class II (Controlled) and Class III, Class IV manufacturers require audits by PMDA. These audits are conducted before issuing product marketing approval and may involve on-site audits or document audits, depending on factors such as ISO 13485 compliance, incident reporting, recalls, or the complexity of the manufacturing process. PMDA generally conducts document audits for overseas manufacturers, verifying the following information during the audit:

Overview of manufacturing facilities Organizational structure Quality manual List of quality documents Manufacturing processes (including validation) MAH contracts Post-marketing surveillance procedures

If the manufacturing facility already has a Medical Device Single Audit Program (MDSAP) audit report, it can generally be exempt from duplicate audits.

QMS certificates are valid for 5 years and should be renewed starting 6 months before the expiration date.

After getting FMR approval, What application needed before formally selling MD into Japan?

Pre-Marketing Approval (PMA) refers to the process that a product must undergo before being marketed.

Pre-Market Approval (PMA) DMAH is a Designated Marketing Authorization Holder appointed by an overseas manufacturer that has obtained product marketing authorization for their product in Japan. The overseas manufacturer is also the applicant for pre-market certification/approval and holds the product’s marketing authorization. DMAH, with the authorization from the overseas manufacturer, carries out relevant operations either before or after applying for marketing certification/approval. Authorization from the overseas manufacturer is necessary for DMAH to transfer the product’s marketing authorization.

Contact Us

Tokyo Evershine BPO Service Limited Corp.

E-mail: tyo4ww@evershinecpa.com
Contact : Andrea Kyu, speak both Japanese and Mandarin
Onarimon Yusen Building 7F,Nishi-Shinbashi 3-23-5,Minato-ku, Tokyo 105-0003, Japan

or
For investment structure relevant with multi-national tax planning and Financial & Legal Due Diligence for M&A (Merge and Acquisition), send an email to HQ4tyo@evershinecpa.com
Dale Chen, Principal Partner/CPA in Taiwan+China+UK will be accountable to your case.
Email address:dalechen@evershinecpa.com
Linkedin address: Dale Chen

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(version: 2024/07)

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