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.

 

South Korea – MFDS Regulatory Landscape

Regulatory Framework and Stakeholders

In South Korea, medical devices fall under the authority of the Ministry of Food and Drug Safety (MFDS). The system covers a wide range of stakeholders, from manufacturers to distributors, with a particular focus on foreign companies appointing a local Authorized Representative (Importer). This representative plays a critical role, handling submissions, labeling, recalls, and post-market safety reporting on behalf of the manufacturer.

 

Classification and Registration

Devices are classified into four risk classes:

• Class I – low risk, reviewed by NIDS.
• Class II – reviewed by designated notified bodies.
• Class III & IV – higher-risk devices, reviewed by MFDS or NIFDS.

In addition to product registration, KGMP (South Korea Good Manufacturing Practice) certification is required. Any site involved in design, assembly, sterilization, packaging, quality control, or shipment must hold KGMP certification. Subcontractors performing these functions are also required to comply. Certification is typically valid for three years, but facilities recognized as “excellent” may extend the cycle to six years. KGMP is closely aligned with ISO 13485, with only minor local adaptations.

 

Product Certificate and Technical Documentation

To obtain a product license, manufacturers must submit technical documentation covering safety, performance, biocompatibility, and electromagnetic compatibility. Devices that involve software must also meet cybersecurity documentation requirements, as clarified in MFDS Notification No. 2023-80. Clinical evidence may be required for higher-risk products, and in certain cases, MFDS allows the use of international testing reports (e.g., ISO, IEC) if equivalent.

 

Regulatory Updates

South Korea has introduced several changes to modernize its system:

• Digital Health: Clearer definitions and pathways for digital healthcare products.
• Fast-Track Approvals: A regulatory route for innovative technologies to reach the market sooner.
• Extended KGMP Cycles: Inspection intervals lengthened to six years for high-performing facilities.
• Adverse Event Reporting: Contact details must be included in device documentation, with reporting timelines set based on severity.
• Implantable Devices: A new legal framework introduces post-market tracking requirements.

These changes reflect South Korea's intent to encourage innovation while maintaining strict oversight of safety and quality.

 

Key Takeaways

Both Japan and South Korea represent promising yet highly regulated medical device markets. In Japan, applicants must navigate a dual review process for product approval and QMS conformity, with increasing attention on usability, cybersecurity, labeling, and EMC compliance. In South Korea, the emphasis lies on KGMP certification and the central role of the Authorized Representative, while new frameworks for digital health, and implantable devices show the country's forward-looking approach.

 

With over 25 years of experience, Qualtech combines global expertise with strong local presence. Our in-house expert teams based in Tokyo, Osaka, and Seoul work directly with clients on Japan and South Korea projects, ensuring practical, up-to-date guidance.

 

Stay tuned with Qualtech for the latest regulatory insights from Japan and South Korea!