Japan has a well-defined regulatory framework for medical devices, ensuring their safety, efficacy, and quality before they reach the market. The process is governed by two key regulatory authorities: the Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA).
Regulatory Authorities
The Ministry of Health, Labour and Welfare (MHLW) is responsible for administrative actions related to medical devices. These actions include issuing guidance, approving medical devices under the Act on Securing Quality, Efficacy, and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act), and determining whether a product qualifies as a medical device.
The Pharmaceuticals and Medical Devices Agency (PMDA) is tasked with conducting product reviews, assessing safety measures, and carrying out post-market surveillance to ensure continued compliance with regulatory requirements.
Medical Device Classification
Medical devices in Japan are categorized into four classes based on their risk level:
- Class I (Extremely low risk) – Examples of devices in this category include surgical instruments and dental mirrors.
- Class II (Low risk) – This class includes devices such as MRI scanners and infusion pumps.
- Class III (Medium risk) – Examples of medium-risk devices include artificial joints and pacemakers.
- Class IV (High risk) – High-risk devices include heart valves and implantable defibrillators.
The specific registration requirements vary depending on the classification of the device. Additionally, device classification is determined based on three main criteria:
- Device class
- Japan Association has JMDN code list (JAAME)
- Substantial equivalence with predicate devices
Medical device classifications in Japan can differ from those in other regulatory regions. For example, Class II products in the U.S. may be classified as Class III in Japan.
Registration Process
In order to market medical devices in Japan, foreign manufacturers must register their products through a Japanese Marketing Authorization Holder (MAH) or a Designated Marketing Authorization Holder (DMAH). The specific registration process depends on the classification of the device:
Class I Devices:
Manufacturers of Class I medical devices must submit a notification to the PMDA before marketing their products in Japan.
Class II Devices:
For Class II devices where certification standards exist, manufacturers must obtain certification from a Registered Certification Body. If no certification standards exist, the manufacturer may need to obtain approval from the PMDA.
Class III Devices:
For Class III devices that have established certification standards, certification by a Registered Certification Body is possible. If certification standards are not available, the manufacturer must seek approval from the PMDA.
Class IV Devices:
All Class IV devices, which carry the highest risk, require approval from the PMDA.
Class III and IV Device Registration Sub-Categories
For higher-risk devices (Class III and IV), registration falls into three sub-categories:
- Me-too or generic devices: These have an existing JMDN code and are based on a previously registered technical file.
- Improved devices: These have an existing JMDN code, but require a new technical file due to modifications.
- New devices: These have no appropriate JMDN code, no predicate device, and usually require local clinical trials before approval.
For In Vitro Diagnostics (IVDs), devices are classified into Classes I-III.
If the classification of a device is unclear, manufacturers may visit and discuss the matter with the regulatory affairs division of local prefectures to seek clarification.
PMDA Consultation Process
Before proceeding to a formal PMDA Consultation session, manufacturers can take advantage of one or two free PMDA consultations. Each free session lasts for 30 minutes and is primarily aimed at advising which formal PMDA consultation should be pursued. During this session, the PMDA may or may not answer specific questions.
For the free consultation, manufacturers are generally required to submit a short PowerPoint presentation (maximum 15 slides) introducing their company and product. If bringing Japanese Key Opinion Leaders (KOLs) to the meeting, it is important to ensure they are truly recognized KOLs rather than mid-level Japanese doctors. Additionally, conducting a rehearsal beforehand is highly recommended to clarify speaking roles and emphasize key slides.
Types of Formal PMDA Consultations
- Zenpan Sodan (General Introductory Consultation): This session is intended to provide general guidance on regulatory pathways. A short PowerPoint introducing the company and product should be submitted before the meeting. The goal is to understand the PMDA’s recommendations and determine the next appropriate consultation.
- Kaihatsumae Sodan (Pre-Development Consultation): This is a formal PMDA consultation session, and it involves a deeper review, covering required testing, supporting data, and other pre-development aspects.
- Rinsho Yohi Sodan (Clinical Trial Consultation): This is a formal PMDA consultation session and focuses on whether additional clinical trials are necessary. It evaluates existing non-clinical data, foreign clinical data, trial protocols, and, if a new trial is required, defines criteria such as patient numbers and study design.
- Please note there are also other types of PMDA consultations too.
Each type of PMDA meeting has different government fees and presentation requirements. Additionally, manufacturers should budget sufficient time for these consultations, as scheduling the first free consultation typically takes 2-3 weeks, while subsequent formal PMDA meetings may take up to 4 months to arrange.
For devices that require certification, a Registered Certification Body (RCB) evaluates compliance with applicable safety and efficacy standards. This process ensures that the device meets Japan’s regulatory requirements before being marketed.
For devices that require approval from the PMDA, the PMDA will conduct a comprehensive product review to assess their safety and efficacy.
This structured regulatory framework ensures that only safe and effective medical devices enter the Japanese market. By enforcing stringent safety measures, Japan maintains high healthcare standards and protects patient safety.
Registration Requirements
For a successful medical device registration in Japan, manufacturers must prepare a registration dossier that includes the following components:
- Dossier application and STED (Summary of Technical Documentation). Information such as product name, manufacturing
- QMS application, which involves either a paper or on-site audit, is required every five years.
- This application must include details such as a manufacturing flow chart, floor plan, ISO 13485 certificate, and quality manual.
- It is similar to ISO 13485:2003, but it is not identical. The QMS review is conducted simultaneously with the product application review and can be performed either on paper or on-site.
- However, even with MDSAP certification, some medical products such as radiopharmaceuticals for IVDs still require an on-site audit
- Manufacturers holding MDSAP certification must still submit a QMS application and pay an additional $2,000 per registered factory on top of the standard government fees.
- Foreign Manufacturer Registration (FMR) application
- Previously known as Foreign Manufacturer Accreditation (FMA) before 2014
- FMA (License process) required more facilities to be audited
- FMR (Accreditation process) reduces the number of facilities needing accreditation (now limited to the design facility, main assembly plant, sterilization site, and domestic distribution center)
- The FMR process is a paper exercise and is not overly complex
- Reliability Investigation Application Form (required for high-risk devices only)
Recent Regulatory Updates
Japan Advances Regulatory and Reimbursement Frameworks for SaMD Products
After a slow start, Japan is now taking decisive action to modernize its regulatory and reimbursement systems for Software as a Medical Device (SaMD) to keep pace with global healthcare innovation. The Pharmaceuticals and Medical Devices Agency (PMDA) has introduced several initiatives aimed at accelerating the review process and integrating SaMD products more effectively into the Japanese healthcare system.
Streamlining SaMD Approvals through Enhanced Review Protocols
A key regulatory development occurred on March 13, 2023, when the PMDA decided that SaMD products would undergo a priority review process with a target completion time of six months. This decision follows the success of the Trial Implementation of Priority Review for Program Medical Devices, which began in September 2022. To qualify for this priority review, SaMDs must either be introduced in Japan for the first time or launched simultaneously in global markets. Additionally, they must offer innovative approaches in treatment or diagnosis that provide significant benefits over existing technologies.
In a further regulatory enhancement, the PMDA considered a new two-stage approval mechanism during its May 29, 2023 meeting. This approach allows for an initial approval based on demonstrated efficacy, followed by a comprehensive assessment using post-market safety and efficacy data. The updated guidance outlines distinct registration criteria for diagnostic, therapeutic, and preventive SaMD products, ensuring a clear pathway for regulatory approval while maintaining patient safety.
Refining Reimbursement Strategies to Support SaMD Integration
Reimbursement policies for SaMD products were a focal point during the Chuikyo meeting (Chuikyo is the reimbursement body in Japan) on July 26, 2023, which discussed fiscal year 2024 reimbursement strategies. The discussion centered on tailoring reimbursement models to reflect the clinical value of SaMD products. Various models, including adjustments to existing medical fees, the application of medical fee premiums, and cost-based evaluations, are under consideration. Additionally, authorities are exploring performance-based reimbursement models, where payment structures are adjusted based on real-world clinical benefits observed post-deployment.
Aligning with International Standards and Practices
To enhance Japan’s competitiveness in the global digital health space, Chuikyo has analyzed reimbursement rates applied in international markets. This alignment ensures that Japan’s pricing structure remains competitive and reflects the innovative nature and clinical benefits of SaMD products. Furthermore, the PMDA launched the “Dash for SaMD2” program to improve regulatory efficiency, expand its SaMD review team, and establish a subscription-based consultation service for SaMD developers.
In its five-year plan (2024-2028) announced on January 22, 2024, the PMDA also committed to finalizing all SaMD registration reviews within six months, ensuring a faster and more predictable regulatory process.
Future Outlook
Japan’s proactive approach in regulating and reimbursing SaMD products underscores its commitment to fostering rapid technological innovation in healthcare. By optimizing both approval processes and reimbursement models, Japan is not only expediting the adoption of advanced medical technologies but also positioning itself as a leader in the global digital health sector.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.