This article has been updated May 29, 2025.
Japan is globally recognized for its comprehensive and well-regulated system for medical device approval. The country’s regulatory framework is known for its scientific rigor, structured evaluation process, and focus on patient safety.
Devices entering the Japanese market must undergo a set of detailed procedures, ensuring that only high quality, effective, and safe medical products reach healthcare providers and patients. If you are a manufacturer or regulatory professional considering Japan for device registration, understanding the end-to-end requirements is essential.
This blog outlines every major step, from initial classification to post market responsibilities, helping you navigate the regulatory landscape with confidence. The process begins by determining the appropriate classification of your medical device.
Japan uses a risk-based classification system with four categories:
- Class I includes general use, low risk devices such as bandages and thermometers.
- Class II covers moderate risk products like dental x ray equipment or ultrasound machines.
- Class III includes higher risk products such as orthopedic implants, while Class IV is reserved for life supporting or life sustaining devices like pacemakers and heart valves.
- The class of the device determines which regulatory pathway it will follow and how thoroughly it will be reviewed.
Each medical device must also be assigned a JMDN code, which stands for Japan Medical Device Nomenclature. These codes are similar in purpose to global identifiers like GMDN codes and are essential for assigning risk classification and deciding the appropriate route for approval.
For low-risk Class I devices, manufacturers are required to submit only a notification to the Pharmaceuticals and Medical Devices Agency, known as the PMDA. Class II devices go through a third-party review process conducted by a Registered Certification Body.
For Class III and Class IV devices, full pre-market approval is needed, and this includes a comprehensive technical and sometimes clinical evaluation by the PMDA. Once your device has been classified, foreign manufacturers must appoint a local Japanese representative called a Marketing Authorization Holder.
This organization is legally responsible for regulatory submissions, handling communications with authorities, and ensuring full compliance throughout the product’s lifecycle in Japan. Additionally, manufacturers are required to complete a Foreign Manufacturer Registration with Japan’s Ministry of Health, Labour and Welfare.
This step confirms that the production sites meet Japanese quality and safety standards. Before submitting your application to authorities, your facility must have a Quality Management System that aligns with Japanese regulations.
Japan follows its own QMS ordinance known as Ministerial Ordinance 169, which is closely aligned with the global ISO 13485 standard. However, there are specific Japan oriented additions that manufacturers must follow.
For devices classified as Class II and above, a QMS audit is usually required. This audit may be conducted by the PMDA or a Registered Certification Body depending on the submission path.
These inspections are critical for verifying that the systems in place can consistently produce safe and reliable devices. Each classification level also comes with different registration timelines and costs.
Class I devices usually take one to two weeks to receive clearance after notification. These are subject to minimal administrative fees.
Class II certifications may take three to six months and often cost between five hundred thousand and one and a half million Japanese yen. Class III and IV devices undergo more in-depth reviews and typically take nine to eighteen months depending on the device’s complexity.
Approval costs for these higher risk devices usually start around two million yen and can exceed five million yen. Labeling is a mandatory and strictly enforced component of Japan’s medical device regulations.
Labels must be in Japanese and include accurate and readable details such as the device name, intended use, usage instructions, warnings, and manufacturer information. Since 2021, Japan has adopted electronic labeling for many devices.
Manufacturers are now expected to upload their package inserts to the Medical Device Safety Information Posting System. Paper inserts may still be required for consumer facing products.
Additionally, devices are required to carry a Unique Device Identifier barcode to support traceability and effective recall if needed. Following product approval, post market obligations become an ongoing part of the regulatory commitment.
Japan has a well-established adverse event reporting system. If a serious and unanticipated event occurs, manufacturers must report it within fifteen days.
Serious but expected events must be reported within thirty days. Minor or non-serious issues are generally included in annual reports.
Reports must be submitted through the PMDA’s electronic reporting platform. The MAH plays a key role in gathering data, submitting reports, and responding to any safety signals that arise.
Healthcare professionals in Japan are also encouraged to report device incidents, strengthening the entire safety monitoring ecosystem. For certain products, especially new or high-risk technologies, clinical trials may be required.
These must comply with Japan’s Good Clinical Practice guidelines. Before starting a trial, sponsors are required to submit a Clinical Trial Notification at least thirty days in advance.
Trials must be conducted in certified medical institutions under the supervision of qualified investigators. While data from foreign studies may be considered in some cases, Japan often prefers domestic trials that reflect the local population’s clinical characteristics and needs.
In addition to the primary regulatory steps, manufacturers should be aware of a few more important obligations. Japan now requires adherence to usability design principles through the JIS T 62366 standard, ensuring that devices are intuitive and reduce the chance of user errors. The UDI system must be implemented for all applicable devices.
Foreign Manufacturer Registration certificates must be renewed every five years, and it is the MAH’s duty to ensure that no certification lapses or documentation deadlines are missed.
In conclusion, Japan’s medical device regulatory environment is detailed and demands high levels of preparation, documentation, and collaboration. From risk classification and submission strategy to labeling, surveillance, and usability engineering, each step has specific rules and expectations. While the process may seem challenging at first, it is also predictable, consistent, and fair. With careful planning and support from a knowledgeable MAH, manufacturers can gain access to one of the world’s most trusted and innovation friendly healthcare markets.
Related post: Medical Device Reimbursement in Japan
