REGULATORY REQUIREMENTS
Medical Device Regulatory Requirements in Japan
Marketing medical devices in Japan requires more than product approval, certification, or a marketing notification. You also need to address the Japan-based marketing authorization arrangements, QMS, statutory labeling, package inserts, and post-market safety management.
REGULATORY FRAMEWORK
What to check before selling a medical device in Japan
Before selling a medical device in Japan, review both the product's regulatory requirements and the Japan-based marketing authorization arrangements.
Related guide: 2025 PMD Act Amendment for Medical Device Companies
For the product, identify the generic device name, JMDN code, classification, and availability of certification standards, then determine whether approval, certification, or a marketing notification is the appropriate pathway.
Also review the Marketing Authorization Holder (MAH) or Designated Marketing Authorization Holder (DMAH), QMS, labeling and package inserts, and post-market safety management needed to support ongoing sales in Japan.
AUTHORITIES / BUSINESS STRUCTURE
Roles of the authorities and Japan-based marketing organizations
The Ministry of Health, Labour and Welfare (MHLW), the Pharmaceuticals and Medical Devices Agency (PMDA), and registered certification bodies (RCBs) have different roles in Japan's medical device regulatory system.
MAHs and DMAHs, in contrast, are not regulatory authorities. They are businesses responsible for the arrangements needed to market medical devices in Japan.
Oversees the regulatory framework, regulatory policy, and administrative procedures under the Pharmaceuticals and Medical Devices Act (PMD Act).
Conducts medical device approval reviews, consultations, QMS conformity assessments, and post-market safety activities.
Provide third-party certification for medical devices covered by certification standards.
Take responsibility for Japan-based marketing arrangements. Foreign manufacturers need to clarify these roles according to the regulatory pathway and distribution arrangements.
CLASSIFICATION
Medical device classification
Medical devices in Japan are classified as Class I, II, III, or IV under the PMD Act.
Determining the regulatory pathway requires more than the class number. Review the generic device name, JMDN code, intended use, design and operating principles, availability of certification standards, and comparison with previously approved or certified devices.
General medical devices
Marketing notification
Controlled medical devices
Certification by an RCB when the device is covered by certification standards; approval when it is not.
Specially controlled medical devices
Approval in principle. Certain designated devices may qualify for certification.
Specially controlled medical devices
Approval in principle.
The classification and regulatory pathway must be checked for each individual device.
Approval, certification, and marketing notification pathways
The main procedures for marketing medical devices in Japan are marketing notification, third-party certification, and approval.
The appropriate procedure is determined by reviewing not only the classification but also the generic device name, JMDN code, availability of certification standards, intended use, design, and operating principles.
Primarily Class I general medical devices
Submit the notification required to market the device, rather than obtaining approval or certification.
Class II and certain Class III devices covered by certification standards
An RCB assesses conformity with the certification standards.
Class II devices not eligible for certification, and Class III and IV devices, as applicable
Obtain approval from the Minister of Health, Labour and Welfare following PMDA review and other applicable assessments of quality, efficacy, and safety documentation.
Devices in the same class may follow different pathways depending on their generic device names and the availability of certification standards.
When starting regulatory work in Japan, review the following:
- Intended use, design, and operating principles.
- Generic device name and JMDN code.
- Classification.
- Availability of certification standards.
- Potential approval, certification, or marketing notification pathway.
For practical support with approval, certification, and marketing notifications, see our support page.
For an integrated registration strategy, see Japan medical device registration
Japan-based marketing authorization arrangements
Foreign manufacturers planning to sell medical devices in Japan need to review the Japan-based marketing authorization arrangements as well as product approval, certification, or marketing notification.
The MAH is responsible for marketing the product in Japan.
Depending on the application method and business structure, foreign manufacturers need to establish the appropriate Japan-based arrangements, including the roles of the MAH or DMAH.
At this stage, review not only the applicant but also QMS, post-market safety management, and the division of responsibilities with distributors.
For selection and coordination, see Japan DMAH agent requirements
QMS conformity assessment
A QMS conformity assessment may be required in connection with approval or certification to establish conformity with Japan's QMS Ministerial Ordinance.
Even when a manufacturer operates a quality management system based on ISO 13485 or another framework overseas, the QMS requirements applicable under Japan's regulatory system need to be reviewed separately.
Typical areas to review include:
- The MAH.
- Manufacturing sites in Japan and overseas.
- Manufacturing processes.
- Quality management arrangements.
- Product standard documents and related quality documentation.
- Design and manufacturing controls.
- Change control.
- Control of nonconforming products.
- Coordination with complaint handling and safety management.
Approval or certification preparation and QMS work should be coordinated, rather than handled in isolation, with attention to the product and manufacturing arrangements.
Labeling and package inserts
Review Japan-specific product labeling, package inserts, and instructions for use (IFU) before selling a medical device in Japan.
On this page, “package inserts” includes electronic package inserts.
Do not simply translate overseas labels and IFU into Japanese. Check that they are consistent with the content of the Japanese approval, certification, or marketing notification.
Typical review items include:
- Brand name.
- Generic device name.
- MAH.
- Intended use.
- Warnings and contraindications.
- Instructions for use.
- Precautions for use.
- Storage conditions.
- Shelf life and expiration date.
- Sterilization information.
- Single-use information.
For details, see the page on statutory labeling and package inserts for medical devices in Japan.
For IVD-specific guidance, see IVD labeling requirements in Japan
Clinical evaluation and overseas data
The clinical data needed for a Japanese submission depend on the device's novelty, intended use, differences from previously approved devices, and available test results.
Overseas clinical study data, literature, performance tests, and post-market data may support a Japanese submission.
However, the availability of overseas documentation does not automatically remove the need for further evaluation in Japan.
Key considerations include:
- Consistency with the intended use proposed in Japan.
- Differences in the target patient population.
- Differences in product specifications.
- Whether the overseas-approved device and the device proposed in Japan are the same.
- Differences from previously approved devices.
- Suitability of the evaluation endpoints.
- Suitability of the test methods.
- Whether evaluation based on published literature is appropriate.
- The need for additional testing.
When clinical evaluation is a significant regulatory issue, consider a PMDA consultation before submitting the formal application.
Post-market regulatory responsibilities
Regulatory responsibilities under the PMD Act continue after a medical device is placed on the Japanese market.
Typical activities include:
- Collecting malfunction and safety information.
- Making required regulatory reports.
- Handling complaints.
- Implementing recalls and other safety measures.
- Managing changes to approved or certified particulars.
- Addressing changes to manufacturing methods and sites.
- Updating package inserts and labeling.
- Maintaining the QMS.
- Evaluating information obtained after market introduction.
Obtaining approval or certification does not bring regulatory work to an end.
Plan for post-market change control and safety management during the application stage.
Explore the Japan market entry process
The market entry guide explains approval, certification, marketing notification, local arrangements, and submission documents in the context of the overall entry process.
FAQ
Questions about medical device regulation in Japan
Does overseas approval simplify the Japanese procedure?+
Overseas approval documentation may be useful, but it does not automatically determine the procedures or documents required in Japan. Review the Japanese generic device name, classification, certification standards, intended use, and other relevant factors.
When should we approach PMDA or an RCB?+
For devices covered by certification standards, consider certification by an RCB. PMDA conducts the approval review for devices that require marketing approval.
Can QMS preparation begin after the application is submitted?+
Reviewing manufacturing sites and quality documents can take time. Start QMS preparation early and coordinate it with submission preparation.
Will a clinical study in Japan be necessary?+
Whether a clinical trial is required should be determined based on the characteristics of the device, differences from previously approved devices, nonclinical test results, and available clinical data.
Official Sources
For the official regulatory basis and current procedures, refer to the following primary sources.
CONTACT
Identify the Japanese regulatory requirements for your device
We review product information, overseas approval and sales status, and your plans for Japan, then outline the regulatory procedures, documentation, QMS preparation, and local arrangements to address.
Discuss Japanese regulatory requirements