The authorization of medical devices in Japan represents a challenge for European and international manufacturers. But it's not one they should shy away from, because Japan is one of the 10 biggest markets in the world.
This comprehensive guide gives you an overview of the requirements you have to meet and the best way to overcome the hurdles in your submission process. We'll explore the regulatory framework, device classification, clinical trial regulations, and the pre-market approval pathway.
Understanding the Japanese regulatory landscape is essential for successful market entry and long-term commercial success in this critical market.
Regulatory Authority in Japan
The Pharmaceuticals and Medical Devices Agency (PMDA) is Japan's regulatory authority responsible for medical device authorization. It is subordinate to the Ministry of Health, Labour and Welfare (MHLW). The PMDA, which was created in 2004, is responsible for the actual tasks within the authorization procedures for medicinal products, medical devices and regenerative medicine products for the Japanese market.
PMDA Responsibilities and Functions
The PMDA performs review, inspection, and consultation about medical devices, whereas the MHLW regulates the law and performs ultimate governmental actions based on evidence provided by PMDA. The PMDA and MHLW work together to govern the pharmaceutical and medical device market.
MHLW Mission and Tasks:
The mission of the MHLW is to protect the population of Japan against health hazards caused by medical devices and pharmaceutical products that are not sufficiently safe or effective or not of sufficiently high quality.
Regarding the regulation of medical devices, the MHLW's tasks include:
- Establishing regulatory frameworks and standards for medical device safety and efficacy
- Reviewing an d approving medical device applications submitted by manufacturers
- Conducting inspections and surveillance of medical device manufacturing facilities
- Monitoring post-market safety and performance of approved devices
- Taking enforcement actions when necessary to protect public health
Key Legislation and Nomenclature
The Pharmaceutical and Medical Device Act (PMD Act) has been the most important law governing medical devices in Japan. It replaced the Pharmaceutical Affairs Law (PAL) and provides the legal framework for device classification, approval, and post-market surveillance.
In contrast to the EU but like in the USA, devices are classified using predefined product codes: the Japanese Medical Device Nomenclature (JMDN). The JMDN was published in 2005 and is based on the fourth version of the Global Medical Device Nomenclature (GMDN).
The JMDN does not just include the eight-digit JMDN code itself, it also contains:
- Device name and description
- Intended use and indications
- Device classification (Class I, II, III, or IV)
- Regulatory pathway requirements
- Applicable standards and guidelines
If no JMDN code is available, a risk-based classification based on Global Harmonization Task Force (GHTF) rules should be used to determine the appropriate regulatory pathway.
Classification for Medical Devices in Japan
There are four classes of medical devices in Japan. The required procedure for pre-market approval depends on the device classification. Understanding your device's classification is critical to planning your regulatory strategy and timeline.
The Four-Class System
The PMD Act differentiates between three types of medical device: general, controlled and specially-controlled medical devices. These are divided into four classes: I (low risk), II, III, IV (high risk).
| Class | Risk Level | Examples | Regulatory Pathway |
|---|---|---|---|
| Class I General Medical Device |
Very low risks in the human body even if device malfunction occurs | In vitro diagnostic medical devices, scalpels, X-ray films, etc. | Notification (No approval needed) |
| Class II Controlled Medical Device |
Relatively low risks in the human body even if device malfunction occurs | MRI, electronic endoscopes, ultrasound diagnostic equipment, etc. | Certification by third-party certification body / Approval from the minister* |
| Class III Specially Controlled Medical Device |
Relatively high risks in the human body if device malfunction occurs | Dialyzers, ventilators, artificial bones, etc. | Approval from the minister |
| Class IV Specially Controlled Medical Device |
Highly invasive, risks in the human life if device malfunction occurs | Pacemakers, heart valves, stent grafts, etc. | Approval from the minister |
*Medical devices that are applied to certification standards will be certified by third-party certification bodies. Medical devices that don't have or are not applicable to certification standards will be reviewed and approved by PMDA.
Comparison: Japan vs. EU vs. USA
Understanding how Japanese classifications compare to other major markets is essential for global regulatory strategy:
| Regulator | Classification System | Number of Classes |
|---|---|---|
| USA (FDA) | Class I, Class II, Class III | 3 classes |
| Japan (PMDA, MHLW) | Class I, Class II, Class III, Class IV | 4 classes |
| EU (Notified Body) | Class I, Class IIa, Class IIb, Class III | 4 classes |
Note that Japan's classification system is more granular than the FDA's three-class system, with a distinct Class IV for the highest-risk devices. This may require different regulatory strategies when pursuing simultaneous approvals across multiple markets.
Process of Pre-market Approval (Class III and IV)
In order to obtain pre-market approval for a medical device, it's necessary to prove that the medical device has sufficient efficacy and safety. PMDA reviews the balance of benefit and risks, and the benefits should be superior to the risks.
Clinical Trial Requirements and Evidence Generation
Whether or not pre-marketing clinical trial (Chiken) is required will be judged considering novelty, background, pre-clinical data, intended purpose, differences from similar devices, and other factors. It's important to have a consultation meeting with PMDA before submitting an application to discuss whether a pre-marketing clinical trial is needed or not.
If a medical device in question has been approved in other countries, it's also possible to use foreign data for approval. Approximately 70% of medical devices approved in 2011 utilized data from foreign clinical trials, with no pre-marketing clinical trials conducted in Japan.
Important Consideration for Foreign Data:
However, it is necessary for clinical trials to be conducted in compliance with Japanese standards and to prove that differences between Japanese and foreign populations do not affect clinical outcomes. In such cases, post-marketing trials or surveillance would be required to obtain data from Japanese and various populations.
PMDA Review and Approval Process
Manufacturers submit an application to PMDA attaching pre-clinical and clinical data, quality documentation, and other supporting evidence. PMDA reviews the quality, safety, and efficacy of the medical device in question. PMDA also performs a Quality Management System inspection to ensure compliance with ISO 13485 or equivalent standards.
PMDA then sends the review result to MHLW who reviews the medical device in collaboration with the review committee. After that, MHLW issues approval of the device and approval to be covered by health insurance.
Clinical Evaluation Requirements
As in Europe, before the medical device is authorized in Japan, manufacturer needs to provide evidence of the clinical performance and safety, and clinical benefits of medical device in a clinical evaluation.
Japan, like Europe, allows this proof to be provided, under certain circumstances, based on literature data. No clinical evidence needs to be submitted for generic/me-too devices. In contrast, clinical studies are required for novel medical devices. For improved devices whose safety and performance have not been sufficiently demonstrated by pre-clinical data and literature data, data from clinical studies also has to be submitted.
Clinical Evidence Pathway:
- Generic/Me-Too Devices: Literature data and comparative analysis may be sufficient
- Improved Devices: Clinical data required if pre-clinical and literature data are insufficient
- Novel Devices: Comprehensive clinical studies required to demonstrate safety and efficacy
- Foreign Data: Acceptable if conducted to Japanese standards and population differences addressed
Clinical Trial Regulations in Japan
When conducting clinical trials, regulations that should be followed in Japan depend on the types of clinical trials. It is important to clarify your clinical trial in order to categorize which regulations are followed.
Types of Clinical Studies and Applicable Regulations
Since April 1st, 2018, the following regulations are applied to clinical trials:
| Study Type | Description | Applicable Regulation |
|---|---|---|
| Pre-marketing Clinical Trials (Chiken) | Clinical studies for unapproved products or off-label use; funded by MAH company | Clinical Study Act (Obligation to comply) |
| Specified Clinical Studies | Clinical studies funded by a MAH company for approved devices | Clinical Study Act (Make effort to comply) |
| Post-marketing Surveillance | Ongoing monitoring after device approval | Pharmaceuticals and Medical Devices Act |
| Other Clinical Studies | Academic or investigator-initiated research | Pharmaceuticals and Medical Devices Act |
Compliance Standards and Guidelines
All clinical research involving human subjects must comply with Japanese-GCP (J-GCP) for medical devices and the Ethical Guidelines for Medical and Health Research Involving Human Subjects. These standards are designed to protect human dignity and rights as well as to carry out research appropriately and smoothly.
For post-marketing surveillance studies, Good Post-marketing Study Practice (GPSP) guidelines must be followed to ensure data quality and regulatory compliance.
Clinical Trial Notification and Submission
Sponsors of clinical trials submit a Clinical Trial Notification (CTN) to PMDA and PMDA reviews the CTN and reports the result to MHLW in 30 days. Online submission has just started from January 11, 2023, streamlining the submission process for sponsors.
Key Points for Clinical Trial Planning:
- Determine the correct study classification (pre-marketing, specified, post-marketing, or other)
- Ensure compliance with applicable regulations (Clinical Study Act or PMD Act)
- Follow Japanese-GCP standards for medical devices
- Obtain IRB/Ethics Committee approval before initiating the study
- Submit Clinical Trial Notification (CTN) to PMDA
- Maintain comprehensive documentation and audit trails
- Report adverse events and safety updates promptly
Key Considerations for Market Entry Success
Successfully introducing a medical device in Japan requires careful planning, regulatory expertise, and understanding of the unique Japanese market dynamics. Here are the critical factors to consider:
Early PMDA Consultation
Engage with PMDA early in development to clarify classification, regulatory pathway, and clinical data requirements. This consultation can save time and resources later.
Device Classification
Accurately determine your device's JMDN code or use GHTF-based classification. This determines the entire regulatory pathway and approval timeline.
Clinical Evidence Strategy
Develop a comprehensive clinical evidence strategy, considering whether foreign data can be used and what additional Japanese data may be required.
Quality Management System
Ensure your QMS complies with ISO 13485 or equivalent Japanese standards. PMDA will conduct QMS inspections as part of the approval process.
Regulatory Documentation
Prepare comprehensive technical dossiers, clinical evaluation reports, and quality documentation in accordance with PMDA requirements and Japanese language standards.
Timeline Planning
Plan for longer timelines than some Western markets. PMDA review typically takes 6-12 months for Class III/IV devices, depending on complexity.
Partner With Eclevar for Japanese Market Entry
Navigating the Japanese regulatory landscape requires specialized expertise in PMDA requirements, clinical trial design, and Japanese regulatory standards. Eclevar MedTech has extensive experience guiding medical device manufacturers through the Japanese approval process.
Our team of regulatory experts and clinical specialists understands the nuances of PMDA submissions and can help ensure your clinical studies are comprehensive, compliant, and positioned for successful clearance in Japan.
Contact Us for Japanese Market SupportKey Takeaways
- Japan is one of the 10 largest medical device markets globally and represents significant commercial opportunity
- PMDA and MHLW work together to regulate medical devices and protect public health
- Japan uses a four-class system (I, II, III, IV) based on risk level and intended use
- Device classification is determined using the JMDN code or GHTF-based rules
- Class III and IV devices require pre-market approval with clinical and quality evidence
- Approximately 70% of approved devices use foreign clinical data, but Japanese population differences must be addressed
- Early PMDA consultation is critical to clarify regulatory pathway and data requirements
- Clinical trials must comply with Japanese-GCP standards and Clinical Study Act requirements
- Quality Management System inspections are mandatory as part of theapproval process
- Post-marketing surveillance may be required to collect Japanese population data
- Online CTN submission has been available since January 2023, streamlining the process
- Eclevar MedTech can guide you through every step of the Japanese regulatory pathway
Conclusion
Introducing medical devices to the Japanese market presents both significant opportunities and regulatory challenges. Japan's sophisticated healthcare system, aging population, and commitment to medical innovation make it one of the most attractive markets globally for medical device manufacturers.
Success in Japan requires a thorough understanding of the PMDA regulatory framework, device classification system, clinical trial requirements, and quality management standards. Early engagement with PMDA, strategic use of foreign clinical data, and careful planning of post-marketing surveillance can significantly streamline the approval process.
The four-class classification system, while more granular than some other markets, provides clear pathways for different risk levels. Class I devices benefit from simplified notification procedures, while Class III and IV devices require comprehensive pre-market approval with robust clinical and quality evidence.
The ability to leverage foreign clinical data is a significant advantage for international manufacturers, provided that Japanese standards are met and population differences are adequately addressed. This approach has been successfully used for approximately 70% of approved devices, demonstrating PMDA's pragmatic approach to evidence evaluation.
Understanding the regulatory landscape is just the first step. Working with experienced regulatory consultants and CRO partners who understand the nuances of Japanese regulations, cultural considerations, and PMDA expectations can be the difference between a smooth approval process and costly delays.
Eclevar MedTech specializes in supporting medical device manufacturers through complex international regulatory pathways, including the Japanese market. Our expertise in clinical trial design, regulatory strategy, and PMDA submissions positions us as your ideal partner for navigating the complexities of Japanese market entry.
Whether you're planning your first entry into Japan or looking to expand your device portfolio in this critical market, understanding these regulatory fundamentals will help you develop a successful market entry strategy.