Japan – PMDA Regulatory Landscape

Regulatory Framework

Japan regulates medical devices under the Act on Securing Quality, Efficacy, and Safety of Products Including Pharmaceuticals and Medical Devices (Act No. 145). This law is supported by Cabinet Orders, Ministerial Orders, and administrative notices that set detailed requirements for manufacturers, importers, and marketers.

Several ministerial orders are central to compliance:

• QMS Order – quality management system for design, manufacturing, and inspection of medical devices and in vitro diagnostic devices.
• GQP Order – standards for product quality assurance during manufacturing and distribution of drugs, quasi-drugs, cosmetics and regenerative products.
• GVP Order – post-market safety management requirements.
• GCP / GLP / GPSP Orders – standards for clinical trials, non-clinical studies, and post-market studies.

This layered structure ensures that regulatory oversight spans the entire lifecycle of a medical device, from product development to long-term safety monitoring.
 

Registration Pathways

Medical device applications can be reviewed by the PMDA (Pharmaceuticals and Medical Devices Agency) or by an RCB (Registered Certification Body), depending on device classification.

Two dossiers are required for market entry:

• STED dossier – product data, including safety and performance.
• QMS dossier – documentation proving the quality compliance of the manufacturing site.

These dossiers are assessed separately but in parallel. QMS conformity is verified through either a desktop or on-site inspection, and a QMS certificate must be obtained alongside product approval. In some cases, particularly for improved devices or new/novel devices without established approval criteria, clinical data will be requested.
 

Regulatory Updates

Recent and upcoming updates reflect Japan's emphasis on modernizing requirements:

• Usability Engineering: From March 2024, manufacturers must integrate usability standards (IEC 62366-1 / JIS T 60601-1-6) into design and manufacturing processes.
• Cybersecurity: From April 2024, medical devices must include documented cybersecurity measures covering the design, manufacturing, and lifecycle stages.
• Labeling: UDI and PI labeling will become mandatory for contact lenses from December 2025. Electronic IFUs are permitted if users can access them via UDI or JAN codes.
• EMC Compliance: By February 2026, medical devices must comply fully with the updated JIS T 0601-1-2:2023 standard for electromagnetic compatibility.

These changes highlight Japan's focus on risk management, patient safety, and the integration of digital considerations into device regulation.