Japan PMDA Medical Device Registration

Regulatory Framework of MHLW and PMDA

The Japanese medical device market is regulated by the Ministry of Health, Labour, and Welfare (MHLW), which oversees the implementation of health policies and the safety of medical products. The Pharmaceuticals and Medical Devices Agency (PMDA) serves as the technical executive arm, conducting scientific reviews of applications for drugs and medical devices, as well as managing post-market safety. The primary legal foundation for these activities is the Act on Securing Quality, Efficacy, and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics, commonly referred to as the PMD Act.

Under the PMD Act, all medical devices must be evaluated for safety and effectiveness before they can be legally commercialized in Japan. The regulatory pathway is determined by the classification of the device, which dictates whether the review will be performed by the PMDA for high-risk products or by a Registered Certification Body (RCB) for lower-risk, standardized products.

Risk Classification and Technical Requirements

Japan utilizes a risk-based classification system that categorizes medical devices into four distinct classes. This system aligns with international principles but features specific Japanese nomenclature and criteria.

Classification Categories under the PMD Act

Class I devices include extremely low-risk products such as scalpels and thermometers. Class II devices represent low-to-medium risk, including technologies like ultrasonic diagnostic equipment and digestive catheters. Class III covers medium-to-high risk products, such as artificial hip joints and bone plates. Class IV is reserved for the highest-risk devices, including pacemakers and artificial heart valves. Each class requires different levels of technical evidence, ranging from simple notification (Todokede) for Class I to complex approval (Shonin) for Class III and IV.

Quality Management System and Ordinance 169

A critical component of Japanese registration is the requirement for a Quality Management System (QMS) that complies with MHLW Ministerial Ordinance #169. While this ordinance is largely harmonized with ISO 13485:2016, Japan requires additional documentation, such as the Japanese Medical Device Master File. Manufacturers must undergo a QMS conformity investigation conducted by the PMDA or an RCB. Japan also participates in the Medical Device Single Audit Program (MDSAP), and a valid MDSAP audit report can often simplify the Japanese QMS evaluation process.

Market Access and Licensing Procedures

Achieving market access in Japan requires a structured approach that involves both product-specific licenses and entity-specific authorizations.

Appointment of a MAH or D-MAH

For manufacturers based outside of Japan, appointing a Marketing Authorization Holder (MAH) or a Designated Marketing Authorization Holder (D-MAH) is a mandatory legal requirement. The MAH must be a legal entity based in Japan and is responsible for the quality and safety of the devices on the market. The MAH manages the registration process, handles import procedures, and serves as the primary liaison with the PMDA and MHLW.

Registration Certificates and Maintenance

Once the PMDA or RCB completes its review, a registration certificate is issued. While the device registration itself does not have a formal expiration date, the associated QMS Conformance Certificate must be renewed every five years to ensure continued compliance with Ordinance 169. Manufacturers must also submit annual reports and notify the authorities of any significant changes to the device design or manufacturing site.

Proregulations' Japan PMDA Registration Services

Our standardized service process facilitates the efficient navigation of the Japanese regulatory landscape to ensure your products meet all requirements of the PMD Act. We offer an expanded suite of professional solutions to manage your Japanese market access:

• Initial product classification and regulatory strategy
  We analyze your device technology against the 16 rules of the PMD Act to determine the correct risk class and optimal registration pathway (Todokede, Ninsho, or Shonin).
• MAH and D-MAH liaison and coordination
  We assist in the selection and management of your Japanese Marketing Authorization Holder, ensuring clear communication and compliance with local representative obligations.
• Ordinance 169 QMS compliance and MDSAP support
  Our experts provide gap analysis between ISO 13485 and Japan's Ordinance 169, including the preparation of the Japanese Medical Device Master File and support for MDSAP report submissions.
• Preparation of Shonin and Ninsho dossiers
  We manage the compilation of comprehensive technical dossiers, ensuring that all clinical data and testing reports are presented according to PMDA expectations.
• Japanese labeling and IFU localization
  We provide professional translation and localization services to ensure all user-facing documentation meets Japanese linguistic and regulatory standards.
• Post-market vigilance and renewal management
  We help establish systems for adverse event reporting and manage the five-year renewal cycles for your QMS certificates to ensure uninterrupted market access.

If you are interested in our Japan PMDA registration services and wish to secure your market position in Japan, please feel free to contact us.