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In Japan, the Pharmaceuticals and Medical Devices Agency (PMDA) serves as the regulatory authority for reviewing and approving pharmaceuticals, medical devices, and regenerative medicine products. The PMDA also conducts postmarket surveillance for this category. Regarding medical devices, the PMDA ensures that all devices marketed in Japan are safe, effective, and of high quality. This administrative agency falls under the Ministry of Health, Labour and Welfare (MHLW).
The PMDA operates under the Pharmaceutical and Medical Device Act (PMD Act), Japan’s regulatory framework that was enacted in 2014. The PMD Act outlines regulations for product approval, manufacturing control, distribution, and quality assurance. Of note, it leverages a risk-based classification model to categorize devices from Class I to Class IV based on their potential impact on patient safety and public health.
The PMDA is similar to other regulatory frameworks like the United States Food & Drug Administration and the European Medicines Agency (EMA). However, it is crucial for all medical device manufacturers seeking to enter the Japanese market to understand its unique procedures and classifications.
The core principles of the PMD Act are:
Patient safety.
Clinical performance.
Transparent documentation.
Traceability.
Risk-based classification and review.
Postmarket accountability.
Medical devices are categorized based on their assessed level of risk to patients and users. These classifications are broken into four levels and aligned with the IMDRF (International Medical Device Regulators Forum) and GHTF (Global Harmonization Task Force).
Devices in this category are classified as low risk. Examples include bandages, tongue depressors, and non-invasive monitors. Manufacturers self-declare compliance with JIS/ISO standards and register via the PMDA online portal.
Devices in this category are classified as moderate risk. Examples include MRI machines, powered wheelchairs, and contact lenses. This classification requires third-party certification by a Registered Certification Body (RCB), such as the Japan Quality Assurance Organization (JQA) or TÜV (Technischer Überwachungsverein). The RCB will verify the QMS (ISO 13485) and technical dossier. The PMDA oversees RCBs; the review generally lasts around three to six months.
Medical devices in this category are classified as high risk. Examples include stents, orthopedic implants, and dialysis machines. Class III devices require MDA pre-market review and MHLW final approval. They also require clinical data (from Japan or accepted foreign trials), GCP (Good Clinical Practice) compliance, and a full QMS audit. The review time typically lasts nine to 12 months.
Examples of highest risk devices include pacemakers, heart valves, neuromodulators, and invasive artificial intelligence (AI) software. These devices undergo the most rigorous PMDA review, including mandatory Japanese clinical trials unless foreign data is accepted under ICH (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use), extensive safety and efficacy validation, and postmarket studies. The review period can last 12 to 24 months or longer.
The first step to comply with Japan’s PMDA regulations is to determine the correct device classification under the PMD Act. Misclassification can delay approval. Manufacturers must identify whether their product qualifies as a medical device and then which class (I-IV) it falls under. Foreign manufacturers need to appoint a Marketing Authorization Holder (MAH) or a Designated Marketing Authorization Holder (DMAH) in Japan. This local entity will take on regulatory responsibility for the product (including submission management, quality audits, and adverse event reporting).
Next, manufacturers must demonstrate compliance with Japan’s QMS Ordinance. This ordinance aligns closely with ISO13485; however, it includes Japan-specific requirements such as local document retention and supplier oversight. PMDA inspectors may conduct on-site or remote audits to verify QMS conformity.
Foreign manufacturers also need to register their production facilities under the Foreign Manufacturer Registration System (FMRS) before receiving product approval.
Manufacturers pursue one of the following pathways, depending on the medical device’s classification:
Notification (Todokede) for Class I devices.
Third-party certification (Ninsho) for Class II devices.
Pre-market approval (Shonin) for Class III and IV devices.
High-risk devices (Class III/IV) require submission of extensive technical documentation including:
Clinical and non-clinical data.
Risk management reports.
Design and manufacturing information.
Performance testing and validation results.
Labeling and Instructions for Use (IFU).
The PMDA will conduct a scientific and regulatory review before forwarding recommendations to MHLW for final approval.
After approval, manufacturers are required to conduct continuous monitoring of product performance. Manufacturers must maintain records of complaints, adverse events, and field safety corrective actions (FSCAs). Any serious adverse events must be reported to the PMDA within the dictated timeframes. Periodic safety update reports (PSURs) may be required depending on the device type. The PMDA may also conduct re-examinations and re-evaluations to confirm continued safety and performance.
All approved medical devices must bear a Marketing Authorization Number and comply with Japan’s Unique Device Identification (UDI) system. Labeling must be in Japanese and clearly state the device name, intended use, MAH/DMAH, and relevant safety warnings.
If a manufacturer modifies an approved device, supplemental submissions may be required. The level of review depends on the significance of the change.
The PMDA emphasizes competence and ethical responsibility for medical device organizations. This means personnel must be adequately trained, and management must ensure continuous improvement (i.e., internal audits and corrective actions).
PMDA regulation compliance is essential to market access in Japan. Its benefits go beyond sheer compliance as the process to achieve approval enhances quality management systems (QMS), product traceability, and overall product quality. Japanese providers and patients view PMDA approval as a mark of quality and reliability, as it denotes independent, rigorous scientific and ethical evaluations by an independent authority. PMDA approval also has cultural significance; transparency and patient safety are core tenets of the Japanese health care system. Notably, this approval also strengthens brand credibility across Asia; Chinese, Korean, and ASEAN (Association of Southeast Asian Nations) often reference Japanese market data.
There are benefits at the global level as well. The PMDA works with the FDA and European Medicines Agency (EMA) through the International Medical Device Regulators Forum (IMDRF). This coordination helps drive cross-market compliance for medical device manufacturers. It also reduces the need for redundant testing and can help accelerate global launches of new medical devices. Manufacturers can leverage data from the PMDA’s real-world evidence programs to support FDA and EMA filings.
Foreign manufacturers must first determine the device classification under the PMD Act. The firm will then designate a DMAH in Japan, register its manufacturing facility with the FMRS, and ensure its QMS is aligned with Ordinance 169. MasterControl can assist by centralizing all regulatory and design documentation in a controlled, audit-ready environment. Simplify submission preparation for review by the PMDA through electronic signatures, automated approval routing, and traceability matrices.
Software-based devices, including those powered by AI algorithms, fall under the PMD Act if they perform diagnostic or therapeutic functions. There are specific SaMD guidelines that address algorithm validation, cybersecurity, and requirements for periodic revalidation when models are retrained. These devices are typically classified as Class II–IV (depending on usage). To receive market approval, SaMD outputs must be validated as accurate, consistent, and explainable. MasterControl solutions can help ensure compliance by managing software design documentation, version control, and audit logs across development cycles.
Global medical device manufacturers in Japan must track and report field performance data to the PMDA. With MasterControl’s Advanced Quality Event Management (Advanced QEM) platform, manufacturers can automate the capture and analysis of complaint data and link corrective action/preventive action (CAPA) actions to device performance trends. They can also generate postmarket surveillance reports to meet PMDA expectations.
The most common deficiencies that lead to delays in PMDA approvals are incomplete STED (Summary Technical Documentation) dossiers, missing or lacking Japanese clinical data for Class III and IV devices, noncompliant QMS, unclear JMDN (Japanese Medical Device Nomenclature) classifications, and untranslated foreign trial summaries. Organizations can also face additional delays if MAH or DMAH roles are undefined or GMP certificates lack PMDA-format specifics.
Japan mandates PMS plans at approval. It requires active data collection via MID-NET registries and hospital networks for four to seven years post-launch. The PMDA enforces manufacturer-led re-examination with clinical follow-up and public relief fund linkage. This leads to high real-world evidence volume and stricter recall triggers.
For major changes under Class III or IV, organizations will need to undergo partial or full Shonin reapproval. Examples of major changes include new indications, design alterations that affect safety and efficacy, and material changes. Minor changes (e.g., label tweaks or manufacturing site moves) require notification or minor change filing if the QMS impact is low. Manufacturers should review the PMDA’s Change Management Table to determine thresholds.
Japan’s CTN is unique in that it follows a 30-day silent approval. Trials will begin automatically unless the PMDA objects. Sponsors also self-certify GCP compliance and will submit it to the PMDA without the need for upfront review. While foreign data is often accepted, Class IV devices may need Japan-specific studies.